Trial Outcomes & Findings for A Follow-on Study of the Long-Term Safety of Aripiprazole in Patients With Chronic Schizophrenia (NCT NCT02435836)

Last Updated: 2015-09-21

Results Overview

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

631 participants

Primary outcome timeframe

Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit

Results posted on

2015-09-21

Participant Flow

This trial was conducted in 631 participants at 139 trial sites in 23 countries.

All participants enrolled in this trial had previously participated in the double-blind aripiprazole; 89 participants from trial 31-97-301 and 542 participants from trial 31-98-304-01. NCT numbers were not available for these 2 trials as this was before the requirement. Studies were initiated in 1997 (31-97-201) and 1998 (31-98-304-01).

Participant milestones

Participant milestones
Measure	Aripiprazole All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Overall Study STARTED	631
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	631

Reasons for withdrawal

Reasons for withdrawal
Measure	Aripiprazole All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Overall Study Lost to Follow-up	21
Overall Study Lack of Efficacy	1
Overall Study Withdrawal by Subject	236
Overall Study Insufficient Clinical Response	26
Overall Study Adverse Event	44
Overall Study Sponsor discontinued trial	167
Overall Study Noncompliance	27
Overall Study Protocol Violation	6
Overall Study Met Withdrawal Criteria	7
Overall Study AE of Worsening Schizophrenia	96

Baseline Characteristics

A Follow-on Study of the Long-Term Safety of Aripiprazole in Patients With Chronic Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aripiprazole n=631 Participants All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Age, Continuous	37.5 Years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	264 Participants n=5 Participants
Sex: Female, Male Male	367 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit

Population: All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.

Outcome measures

Outcome measures
Measure	Aripiprazole n=631 Participants All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 60 (N= 395)	-9.28 Units on a scale Standard Deviation 14.71
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 144 (N= 288)	-11.70 Units on a scale Standard Deviation 17.72
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 156 (N= 279)	-11.90 Units on a scale Standard Deviation 17.47
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 504 (N= 2)	-9.50 Units on a scale Standard Deviation 28.99
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 636 (N= 5)	-7.60 Units on a scale Standard Deviation 22.35
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 648 (N= 2)	-10.00 Units on a scale Standard Deviation 14.14
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 660 (N= 3)	-15.33 Units on a scale Standard Deviation 19.66
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 204 (N= 239)	-12.10 Units on a scale Standard Deviation 17.72
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 216 (N= 238)	-11.54 Units on a scale Standard Deviation 17.05
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 228 (N= 224)	-12.24 Units on a scale Standard Deviation 17.53
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 240 (N= 183)	-12.14 Units on a scale Standard Deviation 19.35
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 252 (N= 139)	-15.19 Units on a scale Standard Deviation 18.61
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 264 (N= 83)	-22.16 Units on a scale Standard Deviation 21.07
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 1 (N= 619)	-1.63 Units on a scale Standard Deviation 7.92
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 2 (N= 595)	-3.19 Units on a scale Standard Deviation 9.64
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 4 (N= 586)	-4.27 Units on a scale Standard Deviation 10.90
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 6 (N= 573)	-4.93 Units on a scale Standard Deviation 12.07
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 8 (N= 552)	-5.35 Units on a scale Standard Deviation 13.03
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 12 (N= 532)	-5.47 Units on a scale Standard Deviation 14.61
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 16 (N= 517)	-6.28 Units on a scale Standard Deviation 14.44
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 24 (N= 489)	-6.78 Units on a scale Standard Deviation 14.22
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 36 (N= 458)	-7.22 Units on a scale Standard Deviation 14.17
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 48 (N= 426)	-8.07 Units on a scale Standard Deviation 15.72
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 72 (N= 382)	-9.81 Units on a scale Standard Deviation 15.98
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 84 (N= 362)	-10.54 Units on a scale Standard Deviation 15.92
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 96 (N= 340)	-10.68 Units on a scale Standard Deviation 16.40
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 108 (N= 328)	-11.46 Units on a scale Standard Deviation 16.56
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 120 (N= 316)	-11.43 Units on a scale Standard Deviation 17.01
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 132 (N= 306)	-11.05 Units on a scale Standard Deviation 17.37
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 168 (N= 272)	-11.69 Units on a scale Standard Deviation 17.11
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 180 (N= 268)	-11.83 Units on a scale Standard Deviation 17.41
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 192 (N= 255)	-11.46 Units on a scale Standard Deviation 18.00
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 276 (N= 58)	-29.45 Units on a scale Standard Deviation 20.33
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 288 (N= 56)	-28.79 Units on a scale Standard Deviation 20.66
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 300 (N= 55)	-21.95 Units on a scale Standard Deviation 19.91
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 312 (N= 37)	-25.35 Units on a scale Standard Deviation 18.41
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 324 (N= 38)	-21.95 Units on a scale Standard Deviation 17.45
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 336 (N= 28)	-24.86 Units on a scale Standard Deviation 17.78
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 348 (N= 8)	-12.88 Units on a scale Standard Deviation 14.71
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 360 (N= 10)	-17.70 Units on a scale Standard Deviation 35.32
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 372 (N= 3)	-10.67 Units on a scale Standard Deviation 4.16
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 384 (N= 5)	-4.60 Units on a scale Standard Deviation 9.07
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 396 (N= 10)	-10.10 Units on a scale Standard Deviation 12.67
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 408 (N= 9)	-5.56 Units on a scale Standard Deviation 7.06
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 420 (N= 4)	-8.00 Units on a scale Standard Deviation 2.83
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 432 (N= 3)	-13.67 Units on a scale Standard Deviation 24.19
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 444 (N= 1)	-28.00 Units on a scale Standard Deviation NA Standard deviation (SD) was not calculated as N= 1.
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 456 (N= 4)	-48.25 Units on a scale Standard Deviation 32.12
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 468 (N= 2)	-36.00 Units on a scale Standard Deviation 2.83
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 480 (N= 1)	-10.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 492 (N= 9)	-10.00 Units on a scale Standard Deviation 13.52
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 672 (N= 1)	1.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Week 696 (N= 1)	-7.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week Last Visit (N= 629)	-2.30 Units on a scale Standard Deviation 22.21

PRIMARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit

Population: All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).

Outcome measures

Outcome measures
Measure	Aripiprazole n=631 Participants All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 24 (N= 489)	-1.54 Units on a scale Standard Deviation 4.26
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 72 (N= 382)	-2.08 Units on a scale Standard Deviation 4.63
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 360 (N= 10)	-3.80 Units on a scale Standard Deviation 7.60
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 1 (N= 619)	-0.39 Units on a scale Standard Deviation 2.51
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 2 (N= 595)	-0.81 Units on a scale Standard Deviation 3.15
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 4 (N= 586)	-1.13 Units on a scale Standard Deviation 3.47
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 6 (N= 573)	-1.23 Units on a scale Standard Deviation 3.70
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 8 (N= 552)	-1.30 Units on a scale Standard Deviation 3.97
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 12 (N= 533)	-1.24 Units on a scale Standard Deviation 4.43
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 16 (N= 517)	-1.43 Units on a scale Standard Deviation 4.20
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 36 (N= 458)	-1.56 Units on a scale Standard Deviation 4.20
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 48 (N= 426)	-1.73 Units on a scale Standard Deviation 4.64
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 60 (N= 395)	-2.01 Units on a scale Standard Deviation 4.32
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 84 (N= 362)	-2.26 Units on a scale Standard Deviation 4.65
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 96 (N= 340)	-2.26 Units on a scale Standard Deviation 4.81
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 108 (N= 328)	-2.50 Units on a scale Standard Deviation 4.76
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 120 (N= 316)	-2.45 Units on a scale Standard Deviation 4.84
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 132 (N= 306)	-2.25 Units on a scale Standard Deviation 5.02
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 144 (N= 289)	-2.49 Units on a scale Standard Deviation 5.03
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 156 (N= 279)	-2.46 Units on a scale Standard Deviation 4.87
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 168 (N= 272)	-2.35 Units on a scale Standard Deviation 4.62
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 180 (N= 268)	-2.40 Units on a scale Standard Deviation 4.78
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 192 (N= 255)	-2.22 Units on a scale Standard Deviation 4.91
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 204 (N= 239)	-2.48 Units on a scale Standard Deviation 4.86
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 216 (N= 238)	-2.21 Units on a scale Standard Deviation 4.57
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 228 (N= 224)	-2.42 Units on a scale Standard Deviation 4.51
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 240 (N= 183)	-2.10 Units on a scale Standard Deviation 5.16
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 252 (N= 139)	-2.74 Units on a scale Standard Deviation 4.81
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 264 (N= 83)	-4.24 Units on a scale Standard Deviation 5.69
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 276 (N= 58)	-5.90 Units on a scale Standard Deviation 5.80
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 288 (N= 56)	-6.30 Units on a scale Standard Deviation 5.61
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 300 (N= 55)	-4.16 Units on a scale Standard Deviation 5.54
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 312 (N= 37)	-5.27 Units on a scale Standard Deviation 5.57
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 324 (N= 38)	-4.45 Units on a scale Standard Deviation 5.64
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 336 (N= 28)	-5.46 Units on a scale Standard Deviation 5.73
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 348 (N= 8)	-0.75 Units on a scale Standard Deviation 1.04
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 372 (N= 3)	-0.67 Units on a scale Standard Deviation 0.58
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 384 (N= 5)	-0.80 Units on a scale Standard Deviation 3.96
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 396 (N= 10)	-2.40 Units on a scale Standard Deviation 3.63
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 408 (N= 9)	-0.89 Units on a scale Standard Deviation 2.80
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 420 (N= 4)	-0.75 Units on a scale Standard Deviation 1.50
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 432 (N= 3)	-4.67 Units on a scale Standard Deviation 8.08
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 444 (N= 1)	-9.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 456 (N= 4)	-10.50 Units on a scale Standard Deviation 5.97
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 468 (N= 2)	-6.50 Units on a scale Standard Deviation 3.54
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 480 (N= 1)	-2.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 492 (N= 9)	-2.00 Units on a scale Standard Deviation 2.65
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 504 (N= 2)	-2.50 Units on a scale Standard Deviation 7.78
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 636 (N= 5)	-1.80 Units on a scale Standard Deviation 4.02
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 648 (N= 2)	-4.50 Units on a scale Standard Deviation 7.78
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 660 (N= 3)	-2.00 Units on a scale Standard Deviation 2.65
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 672 (N= 1)	1.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Week 696 (N= 1)	-1.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week Last Visit (N= 629)	0.23 Units on a scale Standard Deviation 6.58

PRIMARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit

Population: All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).

Outcome measures

Outcome measures
Measure	Aripiprazole n=631 Participants All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 660 (N= 3)	-4.67 Units on a scale Standard Deviation 6.66
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 636 (N= 5)	-1.80 Units on a scale Standard Deviation 5.85
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 648 (N= 2)	0.00 Units on a scale Standard Deviation 0.00
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 12 (N= 532)	-1.54 Units on a scale Standard Deviation 4.01
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 300 (N= 55)	-6.58 Units on a scale Standard Deviation 6.42
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 348 (N= 8)	-4.88 Units on a scale Standard Deviation 5.89
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 492 (N= 9)	-2.00 Units on a scale Standard Deviation 3.61
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 672 (N= 1)	1.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 696 (N= 1)	-3.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Last Visit (N= 629)	-1.34 Units on a scale Standard Deviation 6.09
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 444 (N= 1)	-6.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 1 (N= 619)	-0.35 Units on a scale Standard Deviation 2.18
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 2 (N= 595)	-0.82 Units on a scale Standard Deviation 2.59
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 4 (N= 586)	-1.05 Units on a scale Standard Deviation 3.04
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 6 (N= 573)	-1.24 Units on a scale Standard Deviation 3.38
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 8 (N= 552)	-1.41 Units on a scale Standard Deviation 3.54
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 16 (N= 517)	-1.85 Units on a scale Standard Deviation 4.12
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 24 (N= 489)	-2.02 Units on a scale Standard Deviation 4.13
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 36 (N= 458)	-2.16 Units on a scale Standard Deviation 4.41
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 48 (N= 426)	-2.43 Units on a scale Standard Deviation 4.71
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 60 (N= 395)	-2.75 Units on a scale Standard Deviation 4.38
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 72 (N= 382)	-2.94 Units on a scale Standard Deviation 4.79
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 84 (N= 362)	-3.17 Units on a scale Standard Deviation 4.87
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 96 (N= 340)	-3.22 Units on a scale Standard Deviation 4.99
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 108 (N= 328)	-3.36 Units on a scale Standard Deviation 4.99
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 120 (N= 316)	-3.37 Units on a scale Standard Deviation 5.25
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 132 (N= 306)	-3.41 Units on a scale Standard Deviation 5.29
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 144 (N= 288)	-3.58 Units on a scale Standard Deviation 5.43
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 156 (N= 279)	-3.70 Units on a scale Standard Deviation 5.27
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 168 (N= 272)	-3.68 Units on a scale Standard Deviation 5.28
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 180 (N= 268)	-3.69 Units on a scale Standard Deviation 5.21
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 192 (N= 255)	-3.65 Units on a scale Standard Deviation 5.40
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 204 (N= 239)	-3.79 Units on a scale Standard Deviation 5.37
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 216 (N= 238)	-3.74 Units on a scale Standard Deviation 5.17
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 228 (N= 224)	-3.90 Units on a scale Standard Deviation 5.38
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 240 (N= 183)	-4.09 Units on a scale Standard Deviation 5.86
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 252 (N= 139)	-4.88 Units on a scale Standard Deviation 5.69
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 264 (N= 83)	-6.87 Units on a scale Standard Deviation 6.50
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 276 (N= 58)	-8.71 Units on a scale Standard Deviation 6.57
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 288 (N= 56)	-8.32 Units on a scale Standard Deviation 6.85
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 312 (N= 37)	-7.51 Units on a scale Standard Deviation 5.43
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 324 (N= 38)	-6.63 Units on a scale Standard Deviation 4.44
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 336 (N= 28)	-7.43 Units on a scale Standard Deviation 4.59
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 360 (N= 10)	-5.60 Units on a scale Standard Deviation 9.40
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 372 (N= 3)	-4.33 Units on a scale Standard Deviation 1.53
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 384 (N= 5)	0.00 Units on a scale Standard Deviation 2.12
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 396 (N= 10)	-2.90 Units on a scale Standard Deviation 3.67
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 408 (N= 9)	-1.22 Units on a scale Standard Deviation 2.54
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 420 (N= 4)	-2.25 Units on a scale Standard Deviation 2.22
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 432 (N= 3)	-2.67 Units on a scale Standard Deviation 7.51
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 456 (N= 4)	-13.75 Units on a scale Standard Deviation 9.95
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 468 (N= 2)	-9.00 Units on a scale Standard Deviation 5.66
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 480 (N= 1)	-5.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week Week 504 (N= 2)	-1.50 Units on a scale Standard Deviation 12.02

PRIMARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit

Population: All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.

The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.

Outcome measures

Outcome measures
Measure	Aripiprazole n=631 Participants All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 12 (N= 533)	-0.25 Units on a scale Standard Deviation 0.86
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 16 (N= 517)	-0.30 Units on a scale Standard Deviation 0.86
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 1 (N= 619)	-0.07 Units on a scale Standard Deviation 0.49
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 24 (N= 489)	-0.31 Units on a scale Standard Deviation 0.89
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 36 (N= 458)	-0.32 Units on a scale Standard Deviation 0.95
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 48 (N= 426)	-0.38 Units on a scale Standard Deviation 0.94
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 60 (N= 395)	-0.45 Units on a scale Standard Deviation 0.92
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 72 (N= 382)	-0.45 Units on a scale Standard Deviation 0.93
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 84 (N= 362)	-0.49 Units on a scale Standard Deviation 0.95
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 96 (N= 340)	-0.48 Units on a scale Standard Deviation 0.99
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 2 (N= 595)	-0.13 Units on a scale Standard Deviation 0.60
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 4 (N= 586)	-0.20 Units on a scale Standard Deviation 0.67
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 6 (N= 573)	-0.23 Units on a scale Standard Deviation 0.78
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 108 (N= 328)	-0.51 Units on a scale Standard Deviation 0.95
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 120 (N= 316)	-0.53 Units on a scale Standard Deviation 0.98
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 8 (N= 552)	-0.25 Units on a scale Standard Deviation 0.79
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 564 (N= 17)	-0.41 Units on a scale Standard Deviation 0.87
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 132 (N= 306)	-0.48 Units on a scale Standard Deviation 1.03
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 144 (N= 290)	-0.52 Units on a scale Standard Deviation 1.04
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 156 (N= 279)	-0.53 Units on a scale Standard Deviation 1.00
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 168 (N= 272)	-0.53 Units on a scale Standard Deviation 0.96
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 180 (N= 268)	-0.55 Units on a scale Standard Deviation 0.98
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 192 (N= 255)	-0.54 Units on a scale Standard Deviation 1.04
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 204 (N= 239)	-0.55 Units on a scale Standard Deviation 1.01
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 216 (N= 238)	-0.53 Units on a scale Standard Deviation 0.99
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 576 (N= 17)	-0.35 Units on a scale Standard Deviation 0.86
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 588 (N= 17)	-0.41 Units on a scale Standard Deviation 0.87
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 600 (N= 16)	-0.44 Units on a scale Standard Deviation 0.89
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 612 (N= 16)	-0.44 Units on a scale Standard Deviation 0.89
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 624 (N= 16)	-0.50 Units on a scale Standard Deviation 0.73
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 636 (N= 16)	-0.44 Units on a scale Standard Deviation 0.89
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 648 (N= 10)	-0.70 Units on a scale Standard Deviation 0.67
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 660 (N= 8)	-0.50 Units on a scale Standard Deviation 0.53
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 672 (N= 3)	-0.67 Units on a scale Standard Deviation 0.58
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 684 (N= 1)	-1.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 696 (N= 1)	-1.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Last Visit (N= 629)	-0.00 Units on a scale Standard Deviation 1.31
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 228 (N= 232)	-0.56 Units on a scale Standard Deviation 1.00
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 240 (N= 216)	-0.56 Units on a scale Standard Deviation 1.06
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 252 (N= 208)	-0.58 Units on a scale Standard Deviation 0.96
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 264 (N= 194)	-0.58 Units on a scale Standard Deviation 1.04
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 276 (N= 187)	-0.61 Units on a scale Standard Deviation 1.01
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 288 (N= 177)	-0.64 Units on a scale Standard Deviation 1.02
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 300 (N= 167)	-0.63 Units on a scale Standard Deviation 0.99
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 312 (N= 145)	-0.57 Units on a scale Standard Deviation 1.01
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 324 (N= 137)	-0.60 Units on a scale Standard Deviation 0.99
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 336 (N= 121)	-0.59 Units on a scale Standard Deviation 0.95
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 348 (N= 114)	-0.48 Units on a scale Standard Deviation 0.97
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 360 (N= 105)	-0.54 Units on a scale Standard Deviation 0.98
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 372 (N= 93)	-0.49 Units on a scale Standard Deviation 0.94
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 384 (N= 91)	-0.51 Units on a scale Standard Deviation 0.94
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 396 (N= 80)	-0.53 Units on a scale Standard Deviation 1.06
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 408 (N= 69)	-0.62 Units on a scale Standard Deviation 0.96
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 420 (N= 61)	-0.70 Units on a scale Standard Deviation 1.07
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 432 (N= 58)	-0.69 Units on a scale Standard Deviation 1.16
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 444 (N= 51)	-0.59 Units on a scale Standard Deviation 0.96
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 456 (N= 48)	-0.65 Units on a scale Standard Deviation 1.10
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 468 (N= 37)	-0.46 Units on a scale Standard Deviation 1.04
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 480 (N= 33)	-0.42 Units on a scale Standard Deviation 0.83
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 492 (N= 31)	-0.55 Units on a scale Standard Deviation 0.99
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 504 (N= 21)	-0.57 Units on a scale Standard Deviation 0.93
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 516 (N= 19)	-0.53 Units on a scale Standard Deviation 0.84
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 528 (N= 19)	-0.47 Units on a scale Standard Deviation 0.90
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 540 (N= 18)	-0.61 Units on a scale Standard Deviation 0.70
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week Week 552 (N= 18)	-0.56 Units on a scale Standard Deviation 0.86

PRIMARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit

Population: All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.

The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse.

Outcome measures

Outcome measures
Measure	Aripiprazole n=631 Participants All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 72 (N= 382)	2.73 Units on a scale Standard Deviation 1.11
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 108 (N= 328)	2.60 Units on a scale Standard Deviation 1.12
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 192 (N= 255)	2.59 Units on a scale Standard Deviation 1.20
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 216 (N= 238)	2.56 Units on a scale Standard Deviation 1.20
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 300 (N= 167)	2.26 Units on a scale Standard Deviation 1.16
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 384 (N= 91)	2.50 Units on a scale Standard Deviation 1.52
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 504 (N= 2)	2.50 Units on a scale Standard Deviation 2.12
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 636 (N= 5)	2.00 Units on a scale Standard Deviation 0.00
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 648 (N= 2)	1.50 Units on a scale Standard Deviation 0.71
Mean Clinical Global Impression of Improvement (CGI-I) by Week Last Visit (N= 629)	3.35 Units on a scale Standard Deviation 1.60
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 12 (N= 533)	3.16 Units on a scale Standard Deviation 1.12
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 1 (N= 619)	3.60 Units on a scale Standard Deviation 0.93
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 2 (N= 595)	3.42 Units on a scale Standard Deviation 0.98
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 4 (N= 586)	3.29 Units on a scale Standard Deviation 1.02
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 6 (N= 573)	3.21 Units on a scale Standard Deviation 1.08
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 8 (N= 552)	3.17 Units on a scale Standard Deviation 1.10
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 16 (N= 517)	3.08 Units on a scale Standard Deviation 1.18
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 24 (N= 489)	3.03 Units on a scale Standard Deviation 1.14
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 36 (N= 458)	2.95 Units on a scale Standard Deviation 1.14
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 48 (N= 426)	2.88 Units on a scale Standard Deviation 1.17
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 60 (N= 395)	2.76 Units on a scale Standard Deviation 1.14
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 84 (N= 362)	2.67 Units on a scale Standard Deviation 1.11
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 96 (N= 340)	2.67 Units on a scale Standard Deviation 1.15
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 120 (N= 316)	2.58 Units on a scale Standard Deviation 1.15
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 132 (N= 306)	2.62 Units on a scale Standard Deviation 1.17
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 144 (N= 290)	2.59 Units on a scale Standard Deviation 1.20
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 156 (N= 279)	2.58 Units on a scale Standard Deviation 1.16
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 168 (N= 272)	2.57 Units on a scale Standard Deviation 1.15
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 180 (N= 268)	2.57 Units on a scale Standard Deviation 1.16
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 204 (N= 239)	2.56 Units on a scale Standard Deviation 1.16
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 228 (N= 232)	2.49 Units on a scale Standard Deviation 1.17
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 240 (N= 216)	2.48 Units on a scale Standard Deviation 1.21
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 252 (N= 208)	2.37 Units on a scale Standard Deviation 1.13
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 264 (N= 194)	2.14 Units on a scale Standard Deviation 1.07
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 276 (N= 187)	2.16 Units on a scale Standard Deviation 1.03
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 288 (N= 177)	2.26 Units on a scale Standard Deviation 1.06
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 312 (N= 145)	2.18 Units on a scale Standard Deviation 1.11
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 324 (N= 137)	2.23 Units on a scale Standard Deviation 1.05
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 336 (N= 121)	2.03 Units on a scale Standard Deviation 1.09
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 348 (N= 114)	2.45 Units on a scale Standard Deviation 1.00
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 360 (N= 105)	2.53 Units on a scale Standard Deviation 1.36
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 372 (N= 93)	2.14 Units on a scale Standard Deviation 1.07
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 396 (N= 80)	3.00 Units on a scale Standard Deviation 1.63
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 408 (N= 69)	2.50 Units on a scale Standard Deviation 1.18
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 420 (N= 61)	2.43 Units on a scale Standard Deviation 1.40
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 432 (N= 58)	2.00 Units on a scale Standard Deviation 1.73
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 444 (N= 51)	1.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 456 (N= 48)	1.83 Units on a scale Standard Deviation 0.75
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 468 (N= 37)	2.00 Units on a scale Standard Deviation 0.00
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 480 (N= 33)	2.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 492 (N= 9)	2.33 Units on a scale Standard Deviation 1.32
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 528 (N= 1)	4.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 660 (N= 3)	2.33 Units on a scale Standard Deviation 1.15
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 672 (N= 3)	1.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Clinical Global Impression of Improvement (CGI-I) by Week Week 696 (N= 1)	1.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.

PRIMARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit

Population: All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.

The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in participants with mood disorders. The questionnaire includes questions on the following symptoms. 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The usual cut-off points are: 0 to 6 = normal/ symptom absent, 7 to 19 = mild depression, 20 to 34 = moderate depression, \>34 = severe depression.

Outcome measures

Outcome measures
Measure	Aripiprazole n=631 Participants All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 4 (N= 586)	-1.38 Units on a scale Standard Deviation 4.73
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 6 (N= 572)	-1.54 Units on a scale Standard Deviation 5.15
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 8 (N= 552)	-1.40 Units on a scale Standard Deviation 4.98
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 12 (N= 533)	-1.31 Units on a scale Standard Deviation 5.77
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 16 (N= 517)	-1.60 Units on a scale Standard Deviation 5.41
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 24 (N= 489)	-1.61 Units on a scale Standard Deviation 5.75
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 36 (N= 458)	-1.66 Units on a scale Standard Deviation 5.75
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 48 (N= 425)	-1.75 Units on a scale Standard Deviation 5.47
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 72 (N= 382)	-2.21 Units on a scale Standard Deviation 5.29
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 192 (N= 255)	-2.53 Units on a scale Standard Deviation 6.05
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 408 (N= 9)	-1.89 Units on a scale Standard Deviation 1.27
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 420 (N= 4)	0.75 Units on a scale Standard Deviation 4.11
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 432 (N= 3)	-2.33 Units on a scale Standard Deviation 5.86
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 444 (N= 1)	-1.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 1 (N= 619)	-0.78 Units on a scale Standard Deviation 3.62
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 2 (N= 595)	-1.13 Units on a scale Standard Deviation 4.09
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 60 (N= 395)	-2.13 Units on a scale Standard Deviation 5.41
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 108 (N= 328)	-2.30 Units on a scale Standard Deviation 5.68
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 84 (N= 362)	-2.33 Units on a scale Standard Deviation 5.51
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 120 (N= 316)	-2.40 Units on a scale Standard Deviation 5.67
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 132 (N= 306)	-2.22 Units on a scale Standard Deviation 5.85
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 144 (N= 291)	-2.47 Units on a scale Standard Deviation 5.85
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 156 (N= 279)	-2.51 Units on a scale Standard Deviation 5.64
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 168 (N= 272)	-2.51 Units on a scale Standard Deviation 5.49
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 180 (N= 268)	-2.73 Units on a scale Standard Deviation 5.67
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 348 (N= 8)	-4.00 Units on a scale Standard Deviation 7.45
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 360 (N= 10)	-2.80 Units on a scale Standard Deviation 16.09
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 372 (N= 3)	-2.67 Units on a scale Standard Deviation 2.08
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 384 (N= 5)	0.00 Units on a scale Standard Deviation 0.00
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 204 (N= 239)	-2.69 Units on a scale Standard Deviation 6.20
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 216 (N= 238)	-2.50 Units on a scale Standard Deviation 5.87
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 228 (N= 224)	-2.62 Units on a scale Standard Deviation 5.82
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 240 (N= 183)	-2.92 Units on a scale Standard Deviation 6.50
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 252 (N= 139)	-3.63 Units on a scale Standard Deviation 6.53
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 96 (N= 339)	-2.26 Units on a scale Standard Deviation 5.70
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 264 (N= 83)	-5.52 Units on a scale Standard Deviation 7.89
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 396 (N= 10)	-1.40 Units on a scale Standard Deviation 2.95
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 276 (N= 58)	-7.71 Units on a scale Standard Deviation 8.88
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 288 (N= 56)	-7.57 Units on a scale Standard Deviation 8.64
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 300 (N= 55)	-6.15 Units on a scale Standard Deviation 7.52
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 312 (N= 37)	-7.24 Units on a scale Standard Deviation 8.51
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 324 (N= 38)	-6.32 Units on a scale Standard Deviation 8.76
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 336 (N= 28)	-7.21 Units on a scale Standard Deviation 8.01
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 456 (N= 5)	-9.60 Units on a scale Standard Deviation 8.85
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 468 (N= 2)	-3.00 Units on a scale Standard Deviation 2.83
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 480 (N= 1)	0.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 492 (N= 9)	-6.56 Units on a scale Standard Deviation 8.44
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 504 (N= 2)	-13.50 Units on a scale Standard Deviation 13.44
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 636 (N= 5)	0.40 Units on a scale Standard Deviation 3.36
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 648 (N= 2)	-1.00 Units on a scale Standard Deviation 1.41
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 660 (N= 3)	-4.33 Units on a scale Standard Deviation 2.31
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 672 (N= 1)	-2.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Week 696 (N= 1)	-1.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Last Visit (N= 629)	-0.31 Units on a scale Standard Deviation 8.02

PRIMARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit

Population: All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.

The SAS is composed of 10 items. This scale contains 10 items: Gait, Arm dropping, Shoulder shaking, Elbow rigidity, Wrist rigidity, Head rotation, Glabella Tap, Tremor, Salivation, Akathisia. Grade of severity of each item is rated using a 5-point scale, 1 (normal) and 5 (most severe). The total score ranges from 10 to 50. Negative changes from baseline indicate an improvement, with higher negative values indicating better improvement.

Outcome measures

Outcome measures
Measure	Aripiprazole n=631 Participants All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 480 (N= 1)	-1.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 492 (N= 9)	-3.22 Units on a scale Standard Deviation 5.33
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 360 (N= 9)	-0.44 Units on a scale Standard Deviation 5.75
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 432 (N= 3)	-1.00 Units on a scale Standard Deviation 1.73
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 456 (N= 5)	-7.20 Units on a scale Standard Deviation 8.87
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 504 (N= 2)	-3.00 Units on a scale Standard Deviation 4.24
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 636 (N= 5)	-0.20 Units on a scale Standard Deviation 0.45
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 648 (N= 2)	0.00 Units on a scale Standard Deviation 0.00
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 660 (N= 3)	-1.00 Units on a scale Standard Deviation 1.00
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 672 (N= 1)	-3.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 696 (N= 1)	-7.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Last Visit (N= 628)	-1.36 Units on a scale Standard Deviation 4.31
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 1 (N= 618)	-0.78 Units on a scale Standard Deviation 3.05
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 2 (N= 594)	-1.01 Units on a scale Standard Deviation 3.32
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 4 (N= 585)	-1.06 Units on a scale Standard Deviation 3.68
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 6 (N= 572)	-1.14 Units on a scale Standard Deviation 3.94
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 8 (N= 550)	-1.19 Units on a scale Standard Deviation 4.00
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 12 (N= 532)	-1.28 Units on a scale Standard Deviation 4.03
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 16 (N= 516)	-1.27 Units on a scale Standard Deviation 4.18
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 24 (N= 488)	-1.24 Units on a scale Standard Deviation 3.91
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 36 (N= 456)	-1.10 Units on a scale Standard Deviation 3.79
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 48 (N= 426)	-1.33 Units on a scale Standard Deviation 4.14
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 60 (N= 395)	-1.25 Units on a scale Standard Deviation 3.89
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 72 (N= 382)	-1.36 Units on a scale Standard Deviation 4.07
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 84 (N= 362)	-1.33 Units on a scale Standard Deviation 4.16
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 96 (N= 338)	-1.24 Units on a scale Standard Deviation 3.92
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 108 (N= 328)	-1.29 Units on a scale Standard Deviation 3.83
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 120 (N= 316)	-1.22 Units on a scale Standard Deviation 3.83
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 132 (N= 306)	-1.26 Units on a scale Standard Deviation 3.88
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 144 (N= 289)	-1.26 Units on a scale Standard Deviation 3.99
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 156 (N= 278)	-1.33 Units on a scale Standard Deviation 4.04
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 168 (N= 272)	-1.31 Units on a scale Standard Deviation 3.92
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 180 (N= 268)	-1.43 Units on a scale Standard Deviation 4.08
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 192 (N= 255)	-1.46 Units on a scale Standard Deviation 4.07
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 204 (N= 239)	-1.49 Units on a scale Standard Deviation 4.16
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 216 (N= 238)	-1.39 Units on a scale Standard Deviation 3.48
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 228 (N= 224)	-1.44 Units on a scale Standard Deviation 3.55
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 240 (N= 183)	-1.68 Units on a scale Standard Deviation 3.72
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 252 (N= 139)	-2.11 Units on a scale Standard Deviation 4.16
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 264 (N= 83)	-2.89 Units on a scale Standard Deviation 4.99
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 276 (N= 58)	-3.84 Units on a scale Standard Deviation 5.64
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 288 (N= 56)	-3.88 Units on a scale Standard Deviation 5.77
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 300 (N= 55)	-2.53 Units on a scale Standard Deviation 4.55
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 312 (N= 37)	-2.30 Units on a scale Standard Deviation 4.07
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 324 (N= 38)	-1.76 Units on a scale Standard Deviation 4.10
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 336 (N= 28)	-1.64 Units on a scale Standard Deviation 3.90
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 348 (N= 8)	-2.00 Units on a scale Standard Deviation 2.78
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 372 (N= 3)	-1.00 Units on a scale Standard Deviation 0.00
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 384 (N= 5)	-0.20 Units on a scale Standard Deviation 0.45
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 396 (N= 10)	-0.30 Units on a scale Standard Deviation 1.16
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 408 (N= 9)	-0.89 Units on a scale Standard Deviation 1.27
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 420 (N= 4)	-1.25 Units on a scale Standard Deviation 1.50
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 444 (N= 1)	1.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week Week 468 (N= 2)	0.00 Units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit

Population: All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.

BARS consisted of 4 items: objective observation of akathisia by study physician, subjective feelings of restlessness by participant, participant distress due to akathisia, global evaluation of akathisia. The first 3 items were rated on a 4-point scale: 0 = absence of symptoms to 3 = severe condition. The global clinical evaluation were made on a 6-point scale, (0=absent, 1=questionable, 2=mild, 3=moderate, 4=marked, 5=severe). Participants were observed while they were seated and then stood for a minimum of 2 minutes in each position. Symptoms observed in other situations (e.g., while engaged in neutral conversation or engaged in activity on the ward) may also be rated. Subjective phenomena were elicited by direct questioning. The BARS Global Score was derived from the global clinical assessment of akathisia from the BARS panel. Total score ranges from 0 to 14. Negative changes from baseline indicate improvement, with higher negative values indicating better improvement.

Outcome measures

Outcome measures
Measure	Aripiprazole n=631 Participants All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 2 (N= 595)	-0.20 Units on a scale Standard Deviation 0.70
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 108 (N= 327)	-0.21 Units on a scale Standard Deviation 0.77
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 1 (N= 618)	-0.15 Units on a scale Standard Deviation 0.67
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 4 (N= 586)	-0.20 Units on a scale Standard Deviation 0.74
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 6 (N= 572)	-0.23 Units on a scale Standard Deviation 0.76
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 8 (N= 552)	-0.22 Units on a scale Standard Deviation 0.79
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 12 (N= 533)	-0.22 Units on a scale Standard Deviation 0.78
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 16 (N= 517)	-0.22 Units on a scale Standard Deviation 0.77
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 24 (N= 489)	-0.22 Units on a scale Standard Deviation 0.74
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 36 (N= 458)	-0.21 Units on a scale Standard Deviation 0.75
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 48 (N= 425)	-0.20 Units on a scale Standard Deviation 0.75
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 60 (N= 395)	-0.20 Units on a scale Standard Deviation 0.70
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 72 (N= 382)	-0.19 Units on a scale Standard Deviation 0.73
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 84 (N= 362)	-0.21 Units on a scale Standard Deviation 0.74
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 96 (N= 340)	-0.21 Units on a scale Standard Deviation 0.79
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 120 (N= 316)	-0.20 Units on a scale Standard Deviation 0.75
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 132 (N= 306)	-0.22 Units on a scale Standard Deviation 0.76
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 144 (N= 291)	-0.22 Units on a scale Standard Deviation 0.79
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 156 (N= 278)	-0.24 Units on a scale Standard Deviation 0.79
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 168 (N= 272)	-0.22 Units on a scale Standard Deviation 0.78
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 180 (N= 268)	-0.24 Units on a scale Standard Deviation 0.81
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 192 (N= 255)	-0.29 Units on a scale Standard Deviation 0.79
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 204 (N= 238)	-0.29 Units on a scale Standard Deviation 0.80
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 216 (N= 237)	-0.26 Units on a scale Standard Deviation 0.76
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 228 (N= 223)	-0.26 Units on a scale Standard Deviation 0.78
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 240 (N= 183)	-0.24 Units on a scale Standard Deviation 0.75
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 252 (N= 139)	-0.29 Units on a scale Standard Deviation 0.81
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 264 (N= 83)	-0.51 Units on a scale Standard Deviation 1.06
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 276 (N= 58)	-0.69 Units on a scale Standard Deviation 1.16
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 288 (N= 56)	-0.64 Units on a scale Standard Deviation 1.09
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 300 (N= 55)	-0.51 Units on a scale Standard Deviation 0.96
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 312 (N= 37)	-0.35 Units on a scale Standard Deviation 0.68
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 324 (N= 38)	-0.26 Units on a scale Standard Deviation 0.60
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 336 (N= 28)	-0.29 Units on a scale Standard Deviation 0.66
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 348 (N= 8)	-0.75 Units on a scale Standard Deviation 1.04
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 360 (N= 9)	-0.22 Units on a scale Standard Deviation 0.67
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 372 (N= 3)	0.00 Units on a scale Standard Deviation 0.00
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 384 (N= 5)	0.00 Units on a scale Standard Deviation 0.00
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 396 (N= 10)	-0.10 Units on a scale Standard Deviation 0.32
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 408 (N= 9)	-0.33 Units on a scale Standard Deviation 0.71
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 420 (N= 4)	-0.25 Units on a scale Standard Deviation 0.50
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 432 (N= 3)	0.00 Units on a scale Standard Deviation 0.00
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 444 (N= 1)	0.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 456 (N= 5)	-1.40 Units on a scale Standard Deviation 1.67
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 468 (N= 2)	0.00 Units on a scale Standard Deviation 0.00
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 480 (N= 1)	0.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 492 (N= 9)	-0.56 Units on a scale Standard Deviation 1.01
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 504 (N= 2)	-1.50 Units on a scale Standard Deviation 0.71
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 636 (N= 5)	-0.40 Units on a scale Standard Deviation 0.89
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 648 (N= 2)	0.00 Units on a scale Standard Deviation 0.00
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 660 (N= 3)	-0.67 Units on a scale Standard Deviation 1.15
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 672 (N= 1)	-4.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Week 696 (N= 1)	0.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week Last Visit (N= 629)	-0.26 Units on a scale Standard Deviation 0.85

PRIMARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit

Population: All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.

The AIMS assessment consisted of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) were observed unobtrusively while the participant was at rest (e.g., in the waiting room), and the study physician would make global judgments on the participant's dyskinesia's (items 8 through 10). For this scale, the participant was seated on a hard, firm chair. These items are rated on a five-point scale: 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). The total score ranges from 0 to 40. Negative changes from baseline indicate an improvement, with higher negative values indicating better improvement.

Outcome measures

Outcome measures
Measure	Aripiprazole n=631 Participants All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 1 (N= 619)	-0.21 Units on a scale Standard Deviation 1.61
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 2 (N= 595)	-0.29 Units on a scale Standard Deviation 1.77
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 4 (N= 586)	-0.28 Units on a scale Standard Deviation 1.96
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 6 (N= 572)	-0.34 Units on a scale Standard Deviation 2.25
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 8 (N= 552)	-0.34 Units on a scale Standard Deviation 2.22
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 12 (N= 533)	-0.37 Units on a scale Standard Deviation 2.26
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 16 (N= 517)	-0.39 Units on a scale Standard Deviation 2.31
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 24 (N= 489)	-0.35 Units on a scale Standard Deviation 2.08
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 36 (N= 458)	-0.21 Units on a scale Standard Deviation 1.85
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 48 (N= 425)	-0.35 Units on a scale Standard Deviation 2.17
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 60 (N= 395)	-0.33 Units on a scale Standard Deviation 2.02
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 72 (N= 382)	-0.31 Units on a scale Standard Deviation 2.10
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 84 (N= 362)	-0.31 Units on a scale Standard Deviation 2.12
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 96 (N= 340)	-0.25 Units on a scale Standard Deviation 1.84
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 108 (N= 328)	-0.27 Units on a scale Standard Deviation 1.88
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 120 (N= 316)	-0.26 Units on a scale Standard Deviation 1.85
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 132 (N= 306)	-0.26 Units on a scale Standard Deviation 1.91
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 144 (N= 290)	-0.29 Units on a scale Standard Deviation 1.97
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 156 (N= 279)	-0.31 Units on a scale Standard Deviation 2.04
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 168 (N= 272)	-0.29 Units on a scale Standard Deviation 1.87
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 180 (N= 268)	-0.34 Units on a scale Standard Deviation 2.08
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 192 (N= 255)	-0.35 Units on a scale Standard Deviation 2.08
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 204 (N= 239)	-0.30 Units on a scale Standard Deviation 2.06
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 216 (N= 238)	-0.26 Units on a scale Standard Deviation 1.50
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 228 (N= 224)	-0.31 Units on a scale Standard Deviation 1.41
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 240 (N= 183)	-0.31 Units on a scale Standard Deviation 1.44
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 252 (N= 139)	-0.40 Units on a scale Standard Deviation 1.59
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 264 (N= 83)	-0.61 Units on a scale Standard Deviation 1.95
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 276 (N= 58)	-0.76 Units on a scale Standard Deviation 2.30
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 288 (N= 56)	-0.57 Units on a scale Standard Deviation 2.72
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 300 (N= 55)	-0.18 Units on a scale Standard Deviation 1.45
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 312 (N= 37)	-0.35 Units on a scale Standard Deviation 0.68
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 324 (N= 38)	-0.32 Units on a scale Standard Deviation 0.57
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 336 (N= 28)	-0.36 Units on a scale Standard Deviation 0.56
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 348 (N= 8)	-0.50 Units on a scale Standard Deviation 1.07
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 360 (N= 9)	-0.44 Units on a scale Standard Deviation 0.73
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 372 (N= 3)	0.00 Units on a scale Standard Deviation 0.00
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 384 (N= 5)	0.00 Units on a scale Standard Deviation 0.00
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 396 (N= 10)	0.00 Units on a scale Standard Deviation 0.00
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 408 (N= 9)	0.00 Units on a scale Standard Deviation 0.00
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 420 (N= 4)	0.00 Units on a scale Standard Deviation 0.00
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 432 (N= 3)	0.00 Units on a scale Standard Deviation 0.00
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 444 (N= 1)	0.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 456 (N= 5)	-1.00 Units on a scale Standard Deviation 2.24
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 468 (N= 2)	0.00 Units on a scale Standard Deviation 0.00
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 480 (N= 1)	0.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 492 (N= 9)	-0.44 Units on a scale Standard Deviation 0.53
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 504 (N= 2)	-0.50 Units on a scale Standard Deviation 0.71
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 636 (N= 5)	0.20 Units on a scale Standard Deviation 0.45
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 648 (N= 2)	0.00 Units on a scale Standard Deviation 0.00
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 660 (N= 3)	0.00 Units on a scale Standard Deviation 0.00
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 672 (N= 1)	0.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Week 696 (N= 1)	0.00 Units on a scale Standard Deviation NA SD was not calculated as N= 1.
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week Last Visit (N= 629)	-0.39 Units on a scale Standard Deviation 2.36

PRIMARY outcome

Timeframe: Baseline to Last Visit

Population: Safety Sample includes all randomized participants who receive at least one dose of study medication.

The AEs were one of the primary parameters to measure the safety and tolerability of individual participants. The AEs were captured for all participants from the time the ICF was signed until the end of the trial.

Outcome measures

Outcome measures
Measure	Aripiprazole n=631 Participants All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Number of Participants With Adverse Events (AEs) Participants with serious TEAEs	179 Participants
Number of Participants With Adverse Events (AEs) Participants with severe TEAEs	116 Participants
Number of Participants With Adverse Events (AEs) Participants discontinued medication due to AE	140 Participants
Number of Participants With Adverse Events (AEs) Participants with TEAEs	523 Participants
Number of Participants With Adverse Events (AEs) Participants discontinued due to AEs or death	140 Participants

PRIMARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit

Population: Safety Sample includes all randomized participants who receive at least one dose of study medication.

The vital signs were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance included abnormal values in heart rate, systolic and diastolic blood pressure, respiratory rate and weight that were identified based on pre-defined criteria.

Outcome measures

Outcome measures
Measure	Aripiprazole n=631 Participants All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Percentage of Participants With Vital Signs of Potential Clinical Relevance Heart rate sitting increase ≥15 bpm (N=625)	0.5 percentage of participants
Percentage of Participants With Vital Signs of Potential Clinical Relevance Systolic sitting BP increase ≥20 mmHg (N=627)	0.8 percentage of participants
Percentage of Participants With Vital Signs of Potential Clinical Relevance Systolic sitting BP decrease ≥20 mmHg (N=627)	1.3 percentage of participants
Percentage of Participants With Vital Signs of Potential Clinical Relevance Diastolic sitting BP increase ≥15mmHg (N=627)	3.0 percentage of participants
Percentage of Participants With Vital Signs of Potential Clinical Relevance Weight gain ≥7% (N=622)	38.9 percentage of participants
Percentage of Participants With Vital Signs of Potential Clinical Relevance Weight loss ≥7% (N=622)	23.6 percentage of participants

PRIMARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit

Population: Safety Sample includes all randomized participants who receive at least one dose of study medication.

The measurement of ECG was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, and QTcF that were identified based on pre-defined criteria.

Outcome measures

Outcome measures
Measure	Aripiprazole n=631 Participants All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Percentage of Participants With ECG Measurements of Potential Clinical Relevance Tachycardia (N=612)	0.8 Percentage of participants
Percentage of Participants With ECG Measurements of Potential Clinical Relevance Bradycardia (N=612)	7.5 Percentage of participants
Percentage of Participants With ECG Measurements of Potential Clinical Relevance Sinus tachycardia (N=612)	0.8 Percentage of participants
Percentage of Participants With ECG Measurements of Potential Clinical Relevance Sinus bradycardia (N=612)	7.4 Percentage of participants
Percentage of Participants With ECG Measurements of Potential Clinical Relevance Ventricular premature beat (N=612)	2.9 Percentage of participants
Percentage of Participants With ECG Measurements of Potential Clinical Relevance Primary atrioventricular block (N=606)	2.5 Percentage of participants
Percentage of Participants With ECG Measurements of Potential Clinical Relevance Secondary atrioventricular block (N=612)	0.2 Percentage of participants
Percentage of Participants With ECG Measurements of Potential Clinical Relevance Left bundle branch block (N=612)	0.2 Percentage of participants
Percentage of Participants With ECG Measurements of Potential Clinical Relevance Right bundle branch block (N=612)	16.0 Percentage of participants
Percentage of Participants With ECG Measurements of Potential Clinical Relevance Pre-excitation syndrome (N=612)	0.3 Percentage of participants
Percentage of Participants With ECG Measurements of Potential Clinical Relevance Other intraventricular conduction block (N=611)	1.8 Percentage of participants
Percentage of Participants With ECG Measurements of Potential Clinical Relevance Acute infarction (N=612)	0.2 Percentage of participants
Percentage of Participants With ECG Measurements of Potential Clinical Relevance Old infarction (N=612)	0.7 Percentage of participants
Percentage of Participants With ECG Measurements of Potential Clinical Relevance QTcB (N=612)	8.0 Percentage of participants
Percentage of Participants With ECG Measurements of Potential Clinical Relevance QTcF (N=611)	2.1 Percentage of participants
Percentage of Participants With ECG Measurements of Potential Clinical Relevance QTcN (N=611)	2.3 Percentage of participants

PRIMARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit

Population: Safety Sample includes all randomized participants who receive at least one dose of study medication.

The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria.

Outcome measures

Outcome measures
Measure	Aripiprazole n=631 Participants All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Percentage of Participants With Laboratory Values of Potential Clinical Relevance Urea nitrogen (mg/dl) (N=626)	0.8 Percentage of participants
Percentage of Participants With Laboratory Values of Potential Clinical Relevance Alanine aminotransferase (IU/L) (N=626)	1.1 Percentage of participants
Percentage of Participants With Laboratory Values of Potential Clinical Relevance Aspartate aminotransferase (IU/L) (N=626)	1.0 Percentage of participants
Percentage of Participants With Laboratory Values of Potential Clinical Relevance Bilirubin (mg/dl) (high)(N=626)	3.0 Percentage of participants
Percentage of Participants With Laboratory Values of Potential Clinical Relevance Calcium (mg/dl) (low) (N=626)	3.4 Percentage of participants
Percentage of Participants With Laboratory Values of Potential Clinical Relevance Chloride (meq/l) (low) (N=626)	0.5 Percentage of participants
Percentage of Participants With Laboratory Values of Potential Clinical Relevance Chloride (meq/l) (high) (N=626)	0.2 Percentage of participants
Percentage of Participants With Laboratory Values of Potential Clinical Relevance Creatinine phosphokinase (IU/L) (N=626)	14.9 Percentage of participants
Percentage of Participants With Laboratory Values of Potential Clinical Relevance Creatinine (mg/dl) (N=617)	0.5 Percentage of participants
Percentage of Participants With Laboratory Values of Potential Clinical Relevance Glucose (mg/dl) (N=626)	3.0 Percentage of participants
Percentage of Participants With Laboratory Values of Potential Clinical Relevance Lactic dehydrogenase (IU/L) (N=626)	0.2 Percentage of participants
Percentage of Participants With Laboratory Values of Potential Clinical Relevance Potassium (meq/l) (low) (N=626)	0.2 Percentage of participants
Percentage of Participants With Laboratory Values of Potential Clinical Relevance Potassium (meq/l) (high) (N=626)	5.3 Percentage of participants
Percentage of Participants With Laboratory Values of Potential Clinical Relevance Sodium (meq/l) (low) (N=626)	0.5 Percentage of participants
Percentage of Participants With Laboratory Values of Potential Clinical Relevance Sodium (meq/l) (high) (N=626)	0.2 Percentage of participants
Percentage of Participants With Laboratory Values of Potential Clinical Relevance Uric acid (mg/dl) (N=626)	1.0 Percentage of participants
Percentage of Participants With Laboratory Values of Potential Clinical Relevance Eosinophils (%) (N=624)	3.2 Percentage of participants
Percentage of Participants With Laboratory Values of Potential Clinical Relevance Hematocrit (%) (N=623)	2.7 Percentage of participants
Percentage of Participants With Laboratory Values of Potential Clinical Relevance Hemoglobin (g/dl) (N=625)	2.4 Percentage of participants
Percentage of Participants With Laboratory Values of Potential Clinical Relevance Platelet count (per cubic mm) (low) (N=625)	0.2 Percentage of participants
Percentage of Participants With Laboratory Values of Potential Clinical Relevance Platelet count (per cubic mm) (high) (N=625)	0.3 Percentage of participants
Percentage of Participants With Laboratory Values of Potential Clinical Relevance White blood count (thou/mcl) (low) (N=625)	1.1 Percentage of participants
Percentage of Participants With Laboratory Values of Potential Clinical Relevance White blood count (thou/mcl) (high) (N=625)	3.8 Percentage of participants
Percentage of Participants With Laboratory Values of Potential Clinical Relevance Glucose, urine (N=613)	1.6 Percentage of participants
Percentage of Participants With Laboratory Values of Potential Clinical Relevance Protein, urine (N=599)	1.8 Percentage of participants

Adverse Events

Aripiprazole

Serious events: 179 serious events

Other events: 364 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Aripiprazole n=631 participants at risk All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Blood and lymphatic system disorders Anemia	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Cardiac disorders Atrial flutter	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Cardiac disorders Cardiac failure	0.32% 2/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Cardiac disorders Myocardial infarction	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Cardiac disorders Myocardial ischaemia	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Cardiac disorders Palpitations	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Eye disorders Cataract	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Eye disorders Glaucoma	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Gastrointestinal disorders Abdominal pain	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Gastrointestinal disorders Duodenal ulcer perforation	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Gastrointestinal disorders Inguinal hernia	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Gastrointestinal disorders Umbilical hernia	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Infections and infestations Appendicitis	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Infections and infestations Gangrene	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Infections and infestations Pneumonia	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Infections and infestations Syphilis	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Injury, poisoning and procedural complications Foreign body	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Injury, poisoning and procedural complications Overdose	0.48% 3/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Injury, poisoning and procedural complications Toxicity to various agents	0.32% 2/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Injury, poisoning and procedural complications Traumatic liver injury	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Investigations Blood creatinine phosphokinase increased	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Investigations Electrocardiogram QT prolonged	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Investigations Weight decreased	0.32% 2/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Metabolism and nutrition disorders Decreased appetite	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Metabolism and nutrition disorders Diabetes mellitus	0.32% 2/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Musculoskeletal and connective tissue disorders Back pain	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Musculoskeletal and connective tissue disorders Myopathy	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Musculoskeletal and connective tissue disorders Metastases to liver	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Nervous system disorders Akathisia	0.32% 2/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Nervous system disorders Carpal tunnel syndrome	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Nervous system disorders Dizziness	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Nervous system disorders Multiple sclerosis	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Abnormal behaviour	0.32% 2/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Adjustment disorder	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Agression	0.63% 4/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Agitation	0.32% 2/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Alcohol abuse	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Anxiety	1.6% 10/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Completed suicide	0.63% 4/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Confusional state	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Delusion	0.32% 2/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Depressed mood	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Depression	0.32% 2/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Depressive symptom	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Drug abuse	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Hallucination	0.63% 4/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Hypomania	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Illusion	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Insomnia	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Intentional self-injury	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Persecutory delusion	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Psychotic disorder	3.2% 20/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Restlessness	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Schizophrenia	13.5% 85/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Schizophrenia, paranoid type	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Suicidal ideation	0.32% 2/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Suicidal attempt	0.95% 6/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Reproductive system and breast disorders Bartholin's cyst	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Reproductive system and breast disorders Menorrhagia	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Reproductive system and breast disorders Ovarian cyst	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Reproductive system and breast disorders Prostatic disorder	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Reproductive system and breast disorders Uterine haemorrhage	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Respiratory, thoracic and mediastinal disorders Pulmonary thrombosis	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Social circumstances Homicide	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Social circumstances Respite care	0.32% 2/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Social circumstances Social stay hospitalisation	2.5% 16/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Social circumstances Substance use	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Vascular disorders Hypertension	0.16% 1/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.

Other adverse events

Other adverse events
Measure	Aripiprazole n=631 participants at risk All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Infections and infestations Influenza	7.4% 47/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Investigations Weight increased	8.9% 56/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Nervous system disorders Akathisia	13.3% 84/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Nervous system disorders Extrapyramidal disorder	7.9% 50/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Nervous system disorders Headache	7.6% 48/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Nervous system disorders Tremor	7.9% 50/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Anxiety	11.6% 73/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Insomnia	18.7% 118/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Psychiatric disorders Schizophrenia	12.5% 79/631 • From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.

Additional Information

Global Medical Affairs

Otsuka Pharmaceutical Development and Commercialization, Inc.

Phone: 800 562-3974

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place