Trial Outcomes & Findings for Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of Alzheimer's Type (NCT NCT01438060)

Last Updated: 2013-12-02

Results Overview

The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

232 participants

Primary outcome timeframe

Baseline (Day 0), Week 10

Results posted on

2013-12-02

Participant Flow

232 participants were enrolled, 24 were not randomized (baseline failures).

Participant milestones

Participant milestones
Measure	Placebo Acute Phase: 0 mg, Once daily (10 Weeks)	Aripiprazole Acute Phase: Dosed at 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Acute Phase: Double-blind, 10 Weeks STARTED	102	106
Acute Phase: Double-blind, 10 Weeks COMPLETED	84	88
Acute Phase: Double-blind, 10 Weeks NOT COMPLETED	18	18
Extension Phase: Week 10 to Week 130 STARTED	80	81
Extension Phase: Week 10 to Week 130 COMPLETED	22	25
Extension Phase: Week 10 to Week 130 NOT COMPLETED	58	56
On Study Beyond Week 140 STARTED	0	9
On Study Beyond Week 140 COMPLETED	0	1
On Study Beyond Week 140 NOT COMPLETED	0	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Acute Phase: 0 mg, Once daily (10 Weeks)	Aripiprazole Acute Phase: Dosed at 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Acute Phase: Double-blind, 10 Weeks Adverse Event	7	9
Acute Phase: Double-blind, 10 Weeks Lack of Efficacy	6	3
Acute Phase: Double-blind, 10 Weeks Withdrawal by Subject	3	4
Acute Phase: Double-blind, 10 Weeks Lost to Follow-up	1	0
Acute Phase: Double-blind, 10 Weeks Death	0	2
Acute Phase: Double-blind, 10 Weeks Other Reason	1	0
Extension Phase: Week 10 to Week 130 Adverse Event	15	16
Extension Phase: Week 10 to Week 130 Lack of Efficacy	8	8
Extension Phase: Week 10 to Week 130 Withdrawal by Subject	3	5
Extension Phase: Week 10 to Week 130 Participant Unreliability	1	0
Extension Phase: Week 10 to Week 130 Lost to Follow-up	2	0
Extension Phase: Week 10 to Week 130 Death	22	12
Extension Phase: Week 10 to Week 130 Other Reason	7	15
On Study Beyond Week 140 Adverse Event	0	2
On Study Beyond Week 140 Lack of Efficacy	0	1
On Study Beyond Week 140 Withdrawal by Subject	0	1
On Study Beyond Week 140 Death	0	1
On Study Beyond Week 140 Other Reason	0	3

Baseline Characteristics

Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of Alzheimer's Type

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=102 Participants Acute Phase: 0 mg, Once daily (10 Weeks)	Aripiprazole n=106 Participants Acute Phase: Dosed at 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).	Total n=208 Participants Total of all reporting groups
Age Continuous	82.0 years n=5 Participants	81.0 years n=7 Participants	81.0 years n=5 Participants
Sex: Female, Male Female	74 Participants n=5 Participants	75 Participants n=7 Participants	149 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	31 Participants n=7 Participants	59 Participants n=5 Participants
Race/Ethnicity, Customized White	98 Participants n=5 Participants	105 Participants n=7 Participants	203 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian/ Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Weight	58.8 kg n=5 Participants	59.0 kg n=7 Participants	59.0 kg n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0), Week 10

Population: Last Observation Carried forward (LOCF) data set, efficacy sample. Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=103 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change From Baseline in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 10 in Acute Phase Baseline (Day 0)	12.12 Units on a scale Standard Error 0.60	12.29 Units on a scale Standard Error 0.59
Change From Baseline in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 10 in Acute Phase Mean Change from Baseline at Week 10	-5.52 Units on a scale Standard Error 0.66	-6.55 Units on a scale Standard Error 0.65

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, and 8

Population: LOCF data set, efficacy sample. Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=103 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change From Baseline in NPI Psychosis Subscale Score Through Week 8 in Acute Phase Baseline (Day 0)	12.12 Units on Scale 95% Confidence Interval 0.60 • Interval 10.95 to 13.3	12.29 Units on Scale 95% Confidence Interval 0.59 • Interval 11.12 to 13.46
Change From Baseline in NPI Psychosis Subscale Score Through Week 8 in Acute Phase Week 1	-3.33 Units on Scale 95% Confidence Interval 0.53 • Interval -4.37 to -2.28	-2.26 Units on Scale 95% Confidence Interval 0.52 • Interval -3.29 to -1.22
Change From Baseline in NPI Psychosis Subscale Score Through Week 8 in Acute Phase Week 2	-3.96 Units on Scale 95% Confidence Interval 0.67 • Interval -5.27 to -2.65	-3.81 Units on Scale 95% Confidence Interval 0.66 • Interval -5.11 to -2.5
Change From Baseline in NPI Psychosis Subscale Score Through Week 8 in Acute Phase Week 3	-4.54 Units on Scale 95% Confidence Interval 0.64 • Interval -5.8 to -3.28	-4.86 Units on Scale 95% Confidence Interval 0.64 • Interval -6.12 to -3.61
Change From Baseline in NPI Psychosis Subscale Score Through Week 8 in Acute Phase Week 4	-5.38 Units on Scale 95% Confidence Interval 0.61 • Interval -6.59 to -4.18	-5.66 Units on Scale 95% Confidence Interval 0.61 • Interval -6.86 to -4.47
Change From Baseline in NPI Psychosis Subscale Score Through Week 8 in Acute Phase Week 6	-4.87 Units on Scale 95% Confidence Interval 0.64 • Interval -6.13 to -3.61	-6.00 Units on Scale 95% Confidence Interval 0.63 • Interval -7.25 to -4.75
Change From Baseline in NPI Psychosis Subscale Score Through Week 8 in Acute Phase Week 8	-5.04 Units on Scale 95% Confidence Interval 0.69 • Interval -6.4 to -3.69	-6.01 Units on Scale 95% Confidence Interval 0.68 • Interval -7.36 to -4.67

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Total Score is calculated by adding the Individual Item Scores for all 12 domains, to yield a possible NPI Total Score of 0 to 144. Lower score=less severity. A negative change score from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=103 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change From Baseline in NPI Total Score in Acute Phase Baseline (Day 0)	40.08 Units on a Scale 95% Confidence Interval 1.88 • Interval 36.38 to 43.78	39.82 Units on a Scale 95% Confidence Interval 1.86 • Interval 36.14 to 43.49
Change From Baseline in NPI Total Score in Acute Phase Week 1	-6.26 Units on a Scale 95% Confidence Interval 1.58 • Interval -9.39 to -3.13	-4.13 Units on a Scale 95% Confidence Interval 1.57 • Interval -7.23 to -1.03
Change From Baseline in NPI Total Score in Acute Phase Week 2	-9.98 Units on a Scale 95% Confidence Interval 1.86 • Interval -13.65 to -6.32	-8.40 Units on a Scale 95% Confidence Interval 1.84 • Interval -12.04 to -4.77
Change From Baseline in NPI Total Score in Acute Phase Week 3	-10.85 Units on a Scale 95% Confidence Interval 2.13 • Interval -15.04 to -6.65	-8.61 Units on a Scale 95% Confidence Interval 2.11 • Interval -12.77 to -4.45
Change From Baseline in NPI Total Score in Acute Phase Week 4	-11.81 Units on a Scale 95% Confidence Interval 1.87 • Interval -15.5 to -8.12	-11.74 Units on a Scale 95% Confidence Interval 1.86 • Interval -15.4 to -8.08
Change From Baseline in NPI Total Score in Acute Phase Week 6	-10.47 Units on a Scale 95% Confidence Interval 2.09 • Interval -14.59 to -6.35	-11.61 Units on a Scale 95% Confidence Interval 2.07 • Interval -15.69 to -7.52
Change From Baseline in NPI Total Score in Acute Phase Week 8	-9.68 Units on a Scale 95% Confidence Interval 2.32 • Interval -14.26 to -5.09	-10.71 Units on a Scale 95% Confidence Interval 2.30 • Interval -15.26 to -6.17
Change From Baseline in NPI Total Score in Acute Phase Week 10	-9.75 Units on a Scale 95% Confidence Interval 2.35 • Interval -14.4 to -5.11	-11.20 Units on a Scale 95% Confidence Interval 2.33 • Interval -15.8 to -6.59

SECONDARY outcome

Timeframe: Weeks 1, 2, 3, 4, 6, 8, and 10

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=103 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Participants Who Demonstrated a ≥ 50% Decrease From Baseline to Endpoint in the NPI Psychosis Subscale Score in Acute Phase Week 6	53 Participants	56 Participants
Participants Who Demonstrated a ≥ 50% Decrease From Baseline to Endpoint in the NPI Psychosis Subscale Score in Acute Phase Week 8	58 Participants	64 Participants
Participants Who Demonstrated a ≥ 50% Decrease From Baseline to Endpoint in the NPI Psychosis Subscale Score in Acute Phase Week 10	60 Participants	70 Participants
Participants Who Demonstrated a ≥ 50% Decrease From Baseline to Endpoint in the NPI Psychosis Subscale Score in Acute Phase Week 1	24 Participants	18 Participants
Participants Who Demonstrated a ≥ 50% Decrease From Baseline to Endpoint in the NPI Psychosis Subscale Score in Acute Phase Week 2	37 Participants	34 Participants
Participants Who Demonstrated a ≥ 50% Decrease From Baseline to Endpoint in the NPI Psychosis Subscale Score in Acute Phase Week 3	45 Participants	44 Participants
Participants Who Demonstrated a ≥ 50% Decrease From Baseline to Endpoint in the NPI Psychosis Subscale Score in Acute Phase Week 4	52 Participants	47 Participants

SECONDARY outcome

Timeframe: Weeks 1, 2, 3, 4, 6, 8, and 10

The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Total Score is calculated by adding the Individual Item Scores for all 12 domains, to yield a possible NPI Total Score of 0 to 144. Lower score=less severity. A negative change score from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=103 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Participants Who Demonstrated a ≥ 50% Decrease From Baseline in the Total NPI Score in Acute Phase Week 1	12 Participants	11 Participants
Participants Who Demonstrated a ≥ 50% Decrease From Baseline in the Total NPI Score in Acute Phase Week 2	31 Participants	29 Participants
Participants Who Demonstrated a ≥ 50% Decrease From Baseline in the Total NPI Score in Acute Phase Week 3	35 Participants	33 Participants
Participants Who Demonstrated a ≥ 50% Decrease From Baseline in the Total NPI Score in Acute Phase Week 4	44 Participants	37 Participants
Participants Who Demonstrated a ≥ 50% Decrease From Baseline in the Total NPI Score in Acute Phase Week 6	45 Participants	45 Participants
Participants Who Demonstrated a ≥ 50% Decrease From Baseline in the Total NPI Score in Acute Phase Week 8	52 Participants	50 Participants
Participants Who Demonstrated a ≥ 50% Decrease From Baseline in the Total NPI Score in Acute Phase Week 10	47 Participants	53 Participants

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale:0=not at all distressing to 5=extremely distressing). The NPI Psychosis Subscale Caregiver Distress Score is calculated by adding Individual Item Scores for the domains of Delusions and Hallucinations, to yield a possible total score of 0 to 10. Lower score=less severity. A negative change score from baseline=improvement.

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=103 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change From Baseline in NPI Psychosis Subscale Caregiver Distress Score in Acute Phase Baseline (Day 0)	4.80 Unit on a Scale 95% Confidence Interval 0.25 • Interval 4.3 to 5.29	4.70 Unit on a Scale 95% Confidence Interval 0.25 • Interval 4.21 to 5.19
Change From Baseline in NPI Psychosis Subscale Caregiver Distress Score in Acute Phase Week 1	-0.80 Unit on a Scale 95% Confidence Interval 0.21 • Interval -1.21 to -0.38	-0.64 Unit on a Scale 95% Confidence Interval 0.21 • Interval -1.05 to -0.24
Change From Baseline in NPI Psychosis Subscale Caregiver Distress Score in Acute Phase Week 2	-0.84 Unit on a Scale 95% Confidence Interval 0.23 • Interval -1.3 to -0.38	-0.78 Unit on a Scale 95% Confidence Interval 0.23 • Interval -1.24 to -0.33
Change From Baseline in NPI Psychosis Subscale Caregiver Distress Score in Acute Phase Week 3	-1.15 Unit on a Scale 95% Confidence Interval 0.24 • Interval -1.62 to -0.69	-0.93 Unit on a Scale 95% Confidence Interval 0.23 • Interval -1.4 to -0.47
Change From Baseline in NPI Psychosis Subscale Caregiver Distress Score in Acute Phase Week 4	-1.31 Unit on a Scale 95% Confidence Interval 0.23 • Interval -1.76 to -0.86	-1.28 Unit on a Scale 95% Confidence Interval 0.23 • Interval -1.73 to -0.84
Change From Baseline in NPI Psychosis Subscale Caregiver Distress Score in Acute Phase Week 6	-1.36 Unit on a Scale 95% Confidence Interval 0.27 • Interval -1.89 to -0.84	-1.62 Unit on a Scale 95% Confidence Interval 0.26 • Interval -2.14 to -1.1
Change From Baseline in NPI Psychosis Subscale Caregiver Distress Score in Acute Phase Week 8	-1.18 Unit on a Scale 95% Confidence Interval 0.27 • Interval -1.71 to -0.65	-1.65 Unit on a Scale 95% Confidence Interval 0.27 • Interval -2.17 to -1.12
Change From Baseline in NPI Psychosis Subscale Caregiver Distress Score in Acute Phase Week 10	-1.35 Unit on a Scale 95% Confidence Interval 0.26 • Interval -1.86 to -0.83	-1.79 Unit on a Scale 95% Confidence Interval 0.26 • Interval -2.3 to -1.28

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The total NPI Caregiver Distress Score is calculated by adding the 12 Caregiver Distress Individual Item Scores, to yield a possible total score of 0 to 60. Lower score=less severity. A negative change score from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=103 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change From Baseline in NPI Total Caregiver Distress Score in Acute Phase Baseline (Day 0)	16.58 Units on a Scale 95% Confidence Interval 0.87 • Interval 14.87 to 18.29	17.06 Units on a Scale 95% Confidence Interval 0.86 • Interval 15.37 to 18.76
Change From Baseline in NPI Total Caregiver Distress Score in Acute Phase Week 1	-1.81 Units on a Scale 95% Confidence Interval 0.65 • Interval -3.08 to -0.53	-1.64 Units on a Scale 95% Confidence Interval 0.65 • Interval -2.92 to -0.36
Change From Baseline in NPI Total Caregiver Distress Score in Acute Phase Week 2	-3.25 Units on a Scale 95% Confidence Interval 0.72 • Interval -4.67 to -1.83	-3.04 Units on a Scale 95% Confidence Interval 0.72 • Interval -4.47 to -1.61
Change From Baseline in NPI Total Caregiver Distress Score in Acute Phase Week 3	-4.10 Units on a Scale 95% Confidence Interval 0.81 • Interval -5.76 to -2.44	-2.58 Units on a Scale 95% Confidence Interval 0.84 • Interval -4.25 to -0.92
Change From Baseline in NPI Total Caregiver Distress Score in Acute Phase Week 4	-4.01 Units on a Scale 95% Confidence Interval 0.80 • Interval -5.59 to -2.44	-3.48 Units on a Scale 95% Confidence Interval 0.80 • Interval -5.06 to -1.9
Change From Baseline in NPI Total Caregiver Distress Score in Acute Phase Week 6	-3.58 Units on a Scale 95% Confidence Interval 0.98 • Interval -5.51 to -1.66	-3.72 Units on a Scale 95% Confidence Interval 0.98 • Interval -5.65 to -1.79
Change From Baseline in NPI Total Caregiver Distress Score in Acute Phase Week 8	-3.20 Units on a Scale 95% Confidence Interval 0.99 • Interval -5.16 to -1.25	-3.46 Units on a Scale 95% Confidence Interval 0.99 • Interval -5.42 to -1.5
Change From Baseline in NPI Total Caregiver Distress Score in Acute Phase Week 10	-3.15 Units on a Scale 95% Confidence Interval 1.03 • Interval -5.19 to -1.11	-3.53 Units on a Scale 95% Confidence Interval 1.04 • Interval -5.57 to -1.48

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Severity scale is a 7-point scale that requires the clinician to rate the severity of the illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. The assessment is based on severity of mental illness at the time of rating, 0=not assessed, 1=normal, 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill.

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=102 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score in Acute Phase Baseline (Day 0)	4.84 Units on Scale 95% Confidence Interval 0.09 • Interval 4.67 to 5.01	4.83 Units on Scale 95% Confidence Interval 0.09 • Interval 4.66 to 5.0
Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score in Acute Phase Week 1	-0.19 Units on Scale 95% Confidence Interval 0.08 • Interval -0.34 to -0.04	-0.10 Units on Scale 95% Confidence Interval 0.08 • Interval -0.25 to 0.05
Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score in Acute Phase Week 2	-0.29 Units on Scale 95% Confidence Interval 0.11 • Interval -0.52 to -0.06	-0.19 Units on Scale 95% Confidence Interval 0.12 • Interval -0.41 to 0.04
Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score in Acute Phase Week 3	-0.44 Units on Scale 95% Confidence Interval 0.11 • Interval -0.65 to -0.22	-0.44 Units on Scale 95% Confidence Interval 0.11 • Interval -0.65 to -0.22
Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score in Acute Phase Week 4	-0.47 Units on Scale 95% Confidence Interval 0.12 • Interval -0.7 to -0.24	-0.49 Units on Scale 95% Confidence Interval 0.12 • Interval -0.73 to -0.26
Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score in Acute Phase Week 6	-0.44 Units on Scale 95% Confidence Interval 0.12 • Interval -0.69 to -0.2	-0.58 Units on Scale 95% Confidence Interval 0.12 • Interval -0.83 to -0.34
Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score in Acute Phase Week 8	-0.56 Units on Scale 95% Confidence Interval 0.13 • Interval -0.83 to -0.3	-0.65 Units on Scale 95% Confidence Interval 0.13 • Interval -0.92 to -0.39
Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score in Acute Phase Week 10	-0.54 Units on Scale 95% Confidence Interval 0.14 • Interval -0.82 to -0.26	-0.69 Units on Scale 95% Confidence Interval 0.14 • Interval -0.98 to -0.41

SECONDARY outcome

Timeframe: Weeks 1, 2, 3, 4, 6, 8, and 10

Population: LOCF data set, efficacy sample. n = Participants who had both post baseline and baseline values. Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)

The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Improvement scale is a 7 point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=103 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
CGI Improvement Score in Acute Phase Week 1; n=98, 102	3.81 Units on Scale Standard Error 0.09 • Interval 0.09 to	3.96 Units on Scale Standard Error 0.08
CGI Improvement Score in Acute Phase Week 2; n=98, 102	3.55 Units on Scale Standard Error 0.11	3.71 Units on Scale Standard Error 0.10
CGI Improvement Score in Acute Phase Week 3; n=100, 103	3.37 Units on Scale Standard Error 0.12	3.49 Units on Scale Standard Error 0.11
CGI Improvement Score in Acute Phase Week 4; n=100, 103	3.28 Units on Scale Standard Error 0.12	3.32 Units on Scale Standard Error 0.12
CGI Improvement Score in Acute Phase Week 6; n=100, 103	3.26 Units on Scale Standard Error 0.12	3.23 Units on Scale Standard Error 0.13
CGI Improvement Score in Acute Phase Week 8; n=100, 103	3.11 Units on Scale Standard Error 0.14	3.16 Units on Scale Standard Error 0.13
CGI Improvement Score in Acute Phase Week 10; n=100, 103	3.07 Units on Scale Standard Error 0.15	3.17 Units on Scale Standard Error 0.14

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

The BPRS is designed to measure clinical change in participants and is used as a global measure of psychopathology. The BPRS includes 18 items with items devoted to hallucinatory behavior, suspiciousness, unusual thought content, etc. BPRS is an 18-item clinician rated scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. Total possible score range=18 to 126. A negative change score signifies improvement.

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=103 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score in Acute Phase Baseline (Day 0); n=95, 100	43.42 Unit on Scale 95% Confidence Interval 1.32 • Interval 40.32 to 46.02	43.63 Unit on Scale 95% Confidence Interval 1.28 • Interval 41.1 to 46.16
Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score in Acute Phase Week 2; n=87, 95	-4.65 Unit on Scale 95% Confidence Interval 0.95 • Interval -6.54 to -2.77	-5.82 Unit on Scale 95% Confidence Interval 0.94 • Interval -7.68 to -3.96
Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score in Acute Phase Week 4; n=95, 100	-5.80 Unit on Scale 95% Confidence Interval 0.97 • Interval -7.72 to -3.88	-7.44 Unit on Scale 95% Confidence Interval 0.95 • Interval -9.31 to -5.58
Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score in Acute Phase Week 6; n=95, 100	-6.13 Unit on Scale 95% Confidence Interval 1.09 • Interval -8.29 to -3.97	-8.50 Unit on Scale 95% Confidence Interval 1.07 • Interval -10.6 to -6.4
Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score in Acute Phase Week 8; n=95, 100	-6.45 Unit on Scale 95% Confidence Interval 1.17 • Interval -8.76 to -4.14	-8.47 Unit on Scale 95% Confidence Interval 1.14 • Interval -10.72 to -6.22
Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score in Acute Phase Week 10; n=95, 100	-6.28 Unit on Scale 95% Confidence Interval 1.26 • Interval -9.07 to -4.09	-8.53 Unit on Scale 95% Confidence Interval 1.23 • Interval -10.95 to -6.1

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 10

Population: LOCF data set, efficacy sample. n=Participants who had both post baseline and baseline values. Of the 208 randomized participants, 5 were excluded from the efficacy data set: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)

The MMSE is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language). It is a 19 item scale, the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline.

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=103 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change From Baseline in Mini Mental State Examination (MMSE) Total Score in Acute Phase Baseline (Day 0); N=86,94	14.13 Units on Scale Standard Error 0.60	14.35 Units on Scale Standard Error 0.58
Change From Baseline in Mini Mental State Examination (MMSE) Total Score in Acute Phase Week 10; n=82, 87	0.53 Units on Scale Standard Error 0.37	-0.81 Units on Scale Standard Error 0.36

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=103 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change From Baseline in NPI Individual Item Scores in Acute Phase: Delusions Baseline (Day 0)	7.85 Units on a Scale Interval 7.29 to 8.41	8.11 Units on a Scale Interval 7.55 to 8.67
Change From Baseline in NPI Individual Item Scores in Acute Phase: Delusions Week 1	-2.37 Units on a Scale Interval -3.02 to -1.71	-1.61 Units on a Scale Interval -2.25 to -0.97
Change From Baseline in NPI Individual Item Scores in Acute Phase: Delusions Week 2	-2.84 Units on a Scale Interval -3.69 to -1.98	-2.72 Units on a Scale Interval -3.57 to -1.88
Change From Baseline in NPI Individual Item Scores in Acute Phase: Delusions Week 3	-3.25 Units on a Scale Interval -4.07 to -2.42	-3.50 Units on a Scale Interval -4.32 to -2.69
Change From Baseline in NPI Individual Item Scores in Acute Phase: Delusions Week 4	-3.72 Units on a Scale Interval -4.54 to -2.9	-3.89 Units on a Scale Interval -4.69 to -3.08
Change From Baseline in NPI Individual Item Scores in Acute Phase: Delusions Week 6	-3.45 Units on a Scale Interval -4.28 to -2.61	-3.95 Units on a Scale Interval -4.78 to -3.13
Change From Baseline in NPI Individual Item Scores in Acute Phase: Delusions Week 8	-3.52 Units on a Scale Interval -4.41 to -2.63	-3.91 Units on a Scale Interval -4.79 to -3.03
Change From Baseline in NPI Individual Item Scores in Acute Phase: Delusions Week 10	-3.94 Units on a Scale Interval -4.81 to -3.07	-4.28 Units on a Scale Interval -5.14 to -3.43

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=103 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change From Baseline in NPI Individual Item Scores in Acute Phase: Hallucinations Baseline (Day 0)	4.27 Units on a Scale Interval 3.25 to 5.29	4.18 Units on a Scale Interval 3.17 to 5.19
Change From Baseline in NPI Individual Item Scores in Acute Phase: Hallucinations Week 1	-0.98 Units on a Scale Interval -1.63 to -0.32	-0.65 Units on a Scale Interval -1.3 to 0.0
Change From Baseline in NPI Individual Item Scores in Acute Phase: Hallucinations Week 2	-1.15 Units on a Scale Interval -1.86 to -0.43	-1.09 Units on a Scale Interval -1.8 to -0.38
Change From Baseline in NPI Individual Item Scores in Acute Phase: Hallucinations Week 3	-1.34 Units on a Scale Interval -2.05 to -0.63	-1.37 Units on a Scale Interval -2.08 to -0.67
Change From Baseline in NPI Individual Item Scores in Acute Phase: Hallucinations Week 4	-1.71 Units on a Scale Interval -2.31 to -1.1	-1.79 Units on a Scale Interval -2.4 to -1.19
Change From Baseline in NPI Individual Item Scores in Acute Phase: Hallucinations Week 6	-1.43 Units on a Scale Interval -2.02 to -0.84	-2.03 Units on a Scale Interval -2.62 to -1.45
Change From Baseline in NPI Individual Item Scores in Acute Phase: Hallucinations Week 8	-1.57 Units on a Scale Interval -2.22 to -0.91	-2.12 Units on a Scale Interval -2.77 to -1.47
Change From Baseline in NPI Individual Item Scores in Acute Phase: Hallucinations Week 10	-1.65 Units on a Scale Interval -2.28 to -1.03	-2.30 Units on a Scale Interval -2.92 to -1.67

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=103 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change From Baseline in NPI Individual Item Scores in Acute Phase: Agitation/Aggression Baseline (Day 0)	3.52 Units on a Scale Interval 2.68 to 4.37	4.04 Units on a Scale Interval 3.2 to 4.87
Change From Baseline in NPI Individual Item Scores in Acute Phase: Agitation/Aggression Week 1	-0.34 Units on a Scale Interval -1.12 to 0.43	0.10 Units on a Scale Interval -0.68 to 0.88
Change From Baseline in NPI Individual Item Scores in Acute Phase: Agitation/Aggression Week 2	-1.16 Units on a Scale Interval -1.86 to -0.47	-0.69 Units on a Scale Interval -1.38 to 0.01
Change From Baseline in NPI Individual Item Scores in Acute Phase: Agitation/Aggression Week 3	-0.73 Units on a Scale Interval -1.5 to 0.03	-0.59 Units on a Scale Interval -1.35 to 0.17
Change From Baseline in NPI Individual Item Scores in Acute Phase: Agitation/Aggression Week 4	-0.78 Units on a Scale Interval -1.51 to -0.05	-1.38 Units on a Scale Interval -2.11 to -0.65
Change From Baseline in NPI Individual Item Scores in Acute Phase: Agitation/Aggression Week 6	-0.31 Units on a Scale Interval -1.08 to 0.46	-0.94 Units on a Scale Interval -1.71 to -0.18
Change From Baseline in NPI Individual Item Scores in Acute Phase: Agitation/Aggression Week 8	-0.12 Units on a Scale Interval -0.94 to 0.69	-0.84 Units on a Scale Interval -1.65 to -0.03
Change From Baseline in NPI Individual Item Scores in Acute Phase: Agitation/Aggression Week 10	-0.47 Units on a Scale Interval -1.32 to 0.37	-1.12 Units on a Scale Interval -1.96 to -0.28

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=103 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change From Baseline in NPI Individual Item Scores in Acute Phase: Depression/Dysphoria Baseline (Day 0)	3.27 Units on a Scale Interval 2.59 to 3.95	2.28 Units on a Scale Interval 1.6 to 2.95
Change From Baseline in NPI Individual Item Scores in Acute Phase: Depression/Dysphoria Week 1	0.21 Units on a Scale Interval -0.39 to 0.81	-0.04 Units on a Scale Interval -0.62 to 0.54
Change From Baseline in NPI Individual Item Scores in Acute Phase: Depression/Dysphoria Week 2	-0.44 Units on a Scale Interval -1.01 to 0.13	-0.36 Units on a Scale Interval -0.91 to 0.19
Change From Baseline in NPI Individual Item Scores in Acute Phase: Depression/Dysphoria Week 3	-0.77 Units on a Scale Interval -1.28 to -0.25	-0.33 Units on a Scale Interval -0.84 to 0.17
Change From Baseline in NPI Individual Item Scores in Acute Phase: Depression/Dysphoria Week 4	-0.72 Units on a Scale Interval -1.22 to -0.22	-0.50 Units on a Scale Interval -0.99 to -0.02
Change From Baseline in NPI Individual Item Scores in Acute Phase: Depression/Dysphoria Week 6	-0.47 Units on a Scale Interval -1.04 to 0.1	-0.55 Units on a Scale Interval -1.1 to 0.0
Change From Baseline in NPI Individual Item Scores in Acute Phase: Depression/Dysphoria Week 8	-0.65 Units on a Scale Interval -1.2 to -0.11	-0.54 Units on a Scale Interval -1.07 to -0.01
Change From Baseline in NPI Individual Item Scores in Acute Phase: Depression/Dysphoria Week 10	-0.32 Units on a Scale Interval -0.95 to 0.32	-0.42 Units on a Scale Interval -1.04 to 0.19

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=103 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change From Baseline in NPI Individual Item Scores in Acute Phase: Anxiety Baseline (Day 0)	3.64 Units on a Scale Interval 2.81 to 4.46	3.17 Units on a Scale Interval 2.36 to 3.99
Change From Baseline in NPI Individual Item Scores in Acute Phase: Anxiety Week 1	0.02 Units on a Scale Interval -0.73 to 0.77	0.05 Units on a Scale Interval -0.69 to 0.79
Change From Baseline in NPI Individual Item Scores in Acute Phase: Anxiety Week 2	-0.08 Units on a Scale Interval -0.73 to 0.58	0.08 Units on a Scale Interval -0.56 to 0.72
Change From Baseline in NPI Individual Item Scores in Acute Phase: Anxiety Week 3	-0.43 Units on a Scale Interval -1.14 to 0.29	0.07 Units on a Scale Interval -0.63 to 0.77
Change From Baseline in NPI Individual Item Scores in Acute Phase: Anxiety Week 4	-0.80 Units on a Scale Interval -1.47 to -0.14	-0.38 Units on a Scale Interval -1.03 to 0.27
Change From Baseline in NPI Individual Item Scores in Acute Phase: Anxiety Week 6	-0.79 Units on a Scale Interval -1.49 to -0.08	-0.13 Units on a Scale Interval -0.82 to 0.57
Change From Baseline in NPI Individual Item Scores in Acute Phase: Anxiety Week 8	-0.23 Units on a Scale Interval -0.9 to 0.44	-0.21 Units on a Scale Interval -0.87 to 0.46
Change From Baseline in NPI Individual Item Scores in Acute Phase: Anxiety Week 10	-0.43 Units on a Scale Interval -1.13 to 0.26	-0.31 Units on a Scale Interval -0.99 to 0.37

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=103 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change From Baseline in NPI Individual Item Scores in Acute Phase: Apathy/Indifference Baseline (Day 0)	4.14 Units on a Scale Interval 3.41 to 4.86	3.47 Units on a Scale Interval 2.75 to 4.19
Change From Baseline in NPI Individual Item Scores in Acute Phase: Apathy/Indifference Week 1	0.03 Units on a Scale Interval -0.66 to 0.71	-0.70 Units on a Scale Interval -1.37 to -0.03
Change From Baseline in NPI Individual Item Scores in Acute Phase: Apathy/Indifference Week 2	-0.48 Units on a Scale Interval -1.11 to 0.15	-0.76 Units on a Scale Interval -1.37 to -0.14
Change From Baseline in NPI Individual Item Scores in Acute Phase: Apathy/Indifference Week 3	-0.09 Units on a Scale Interval -0.8 to 0.62	-0.36 Units on a Scale Interval -1.06 to 0.33
Change From Baseline in NPI Individual Item Scores in Acute Phase: Apathy/Indifference Week 4	-0.65 Units on a Scale Interval -1.39 to 0.1	-0.67 Units on a Scale Interval -1.4 to 0.06
Change From Baseline in NPI Individual Item Scores in Acute Phase: Apathy/Indifference Week 6	-0.63 Units on a Scale Interval -1.43 to 0.17	-0.40 Units on a Scale Interval -1.18 to 0.38
Change From Baseline in NPI Individual Item Scores in Acute Phase: Apathy/Indifference Week 8	-0.87 Units on a Scale Interval -1.6 to -0.15	-0.21 Units on a Scale Interval -0.92 to 0.49
Change From Baseline in NPI Individual Item Scores in Acute Phase: Apathy/Indifference Week 10	-0.95 Units on a Scale Interval -1.78 to -0.11	-0.09 Units on a Scale Interval -0.91 to 0.72

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=103 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change From Baseline in NPI Individual Item Scores in Acute Phase: Elation/Euphoria Week 3	-0.48 Units on a Scale Interval -0.76 to -0.2	-0.27 Units on a Scale Interval -0.54 to 0.01
Change From Baseline in NPI Individual Item Scores in Acute Phase: Elation/Euphoria Baseline (Day 0)	0.56 Units on a Scale Interval 0.06 to 1.05	0.73 Units on a Scale Interval 0.24 to 1.23
Change From Baseline in NPI Individual Item Scores in Acute Phase: Elation/Euphoria Week 1	-0.48 Units on a Scale Interval -0.75 to -0.22	-0.26 Units on a Scale Interval -0.52 to 0.01
Change From Baseline in NPI Individual Item Scores in Acute Phase: Elation/Euphoria Week 2	-0.37 Units on a Scale Interval -0.63 to -0.11	-0.18 Units on a Scale Interval -0.43 to 0.08
Change From Baseline in NPI Individual Item Scores in Acute Phase: Elation/Euphoria Week 4	-0.47 Units on a Scale Interval -0.66 to -0.28	-0.40 Units on a Scale Interval -0.59 to -0.21
Change From Baseline in NPI Individual Item Scores in Acute Phase: Elation/Euphoria Week 6	-0.38 Units on a Scale Interval -0.58 to -0.18	-0.39 Units on a Scale Interval -0.59 to -0.2
Change From Baseline in NPI Individual Item Scores in Acute Phase: Elation/Euphoria Week 8	-0.32 Units on a Scale Interval -0.59 to -0.04	-0.25 Units on a Scale Interval -0.52 to 0.03
Change From Baseline in NPI Individual Item Scores in Acute Phase: Elation/Euphoria Week 10	-0.42 Units on a Scale Interval -0.65 to -0.19	-0.36 Units on a Scale Interval -0.59 to -0.14

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=103 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change From Baseline in NPI Individual Item Scores in Acute Phase: Disinhibition Baseline (Day 0)	0.98 Units on a Scale Interval 0.39 to 1.57	1.36 Units on a Scale Interval 0.77 to 1.94
Change From Baseline in NPI Individual Item Scores in Acute Phase: Disinhibition Week 1	-0.14 Units on a Scale Interval -0.54 to 0.25	-0.39 Units on a Scale Interval -0.79 to 0.0
Change From Baseline in NPI Individual Item Scores in Acute Phase: Disinhibition Week 2	-0.42 Units on a Scale Interval -0.91 to 0.07	-0.44 Units on a Scale Interval -0.93 to 0.05
Change From Baseline in NPI Individual Item Scores in Acute Phase: Disinhibition Week 3	-0.27 Units on a Scale Interval -0.86 to 0.32	-0.21 Units on a Scale Interval -0.8 to 0.38
Change From Baseline in NPI Individual Item Scores in Acute Phase: Disinhibition Week 4	-0.55 Units on a Scale Interval -1.04 to -0.06	-0.67 Units on a Scale Interval -1.16 to -0.19
Change From Baseline in NPI Individual Item Scores in Acute Phase: Disinhibition Week 6	-0.19 Units on a Scale Interval -0.64 to 0.26	-0.72 Units on a Scale Interval -1.17 to -0.28
Change From Baseline in NPI Individual Item Scores in Acute Phase: Disinhibition Week 8	-0.20 Units on a Scale Interval -0.67 to 0.28	-0.44 Units on a Scale Interval -0.91 to 0.03
Change From Baseline in NPI Individual Item Scores in Acute Phase: Disinhibition Week 10	0.07 Units on a Scale Interval -0.47 to 0.6	-0.35 Units on a Scale Interval -0.88 to 0.18

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=103 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change From Baseline in NPI Individual Item Scores in Acute Phase: Irritability/Lability Baseline (Day 0)	3.73 Units on a Scale Interval 2.8 to 4.66	4.36 Units on a Scale Interval 3.44 to 5.28
Change From Baseline in NPI Individual Item Scores in Acute Phase: Irritability/Lability Week 1	-0.73 Units on a Scale Interval -1.48 to 0.02	-0.09 Units on a Scale Interval -0.84 to 0.66
Change From Baseline in NPI Individual Item Scores in Acute Phase: Irritability/Lability Week 2	-0.89 Units on a Scale Interval -1.65 to -0.12	-0.69 Units on a Scale Interval -1.45 to 0.08
Change From Baseline in NPI Individual Item Scores in Acute Phase: Irritability/Lability Week 3	-1.11 Units on a Scale Interval -1.89 to -0.32	-1.09 Units on a Scale Interval -1.87 to -0.3
Change From Baseline in NPI Individual Item Scores in Acute Phase: Irritability/Lability Week 4	-0.75 Units on a Scale Interval -1.53 to 0.02	-1.53 Units on a Scale Interval -2.3 to -0.76
Change From Baseline in NPI Individual Item Scores in Acute Phase: Irritability/Lability Week 6	-0.42 Units on a Scale Interval -1.19 to 0.36	-1.29 Units on a Scale Interval -2.06 to -0.51
Change From Baseline in NPI Individual Item Scores in Acute Phase: Irritability/Lability Week 8	-0.33 Units on a Scale Interval -1.16 to 0.5	-0.99 Units on a Scale Interval -1.82 to -0.16
Change From Baseline in NPI Individual Item Scores in Acute Phase: Irritability/Lability Week 10	-0.24 Units on a Scale Interval -1.02 to 0.53	-1.26 Units on a Scale Interval -2.03 to -0.48

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=103 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change From Baseline in NPI Individual Item Scores in Acute Phase: Aberrant Motor Behavior Baseline (Day 0)	3.67 Units on a Scale Interval 2.69 to 4.66	3.61 Units on a Scale Interval 2.63 to 4.59
Change From Baseline in NPI Individual Item Scores in Acute Phase: Aberrant Motor Behavior Week 1	-0.66 Units on a Scale Interval -1.26 to -0.06	0.18 Units on a Scale Interval -0.42 to 0.77
Change From Baseline in NPI Individual Item Scores in Acute Phase: Aberrant Motor Behavior Week 2	-0.84 Units on a Scale Interval -1.63 to -0.06	-0.51 Units on a Scale Interval -1.29 to 0.27
Change From Baseline in NPI Individual Item Scores in Acute Phase: Aberrant Motor Behavior Week 3	-1.68 Units on a Scale Interval -2.45 to -0.09	-0.66 Units on a Scale Interval -1.43 to 0.12
Change From Baseline in NPI Individual Item Scores in Acute Phase: Aberrant Motor Behavior Week 4	-0.91 Units on a Scale Interval -1.73 to -0.09	-0.16 Units on a Scale Interval -0.98 to 0.65
Change From Baseline in NPI Individual Item Scores in Acute Phase: Aberrant Motor Behavior Week 6	-0.89 Units on a Scale Interval -1.64 to -0.13	-0.61 Units on a Scale Interval -1.36 to 0.14
Change From Baseline in NPI Individual Item Scores in Acute Phase: Aberrant Motor Behavior Week 8	-1.06 Units on a Scale Interval -1.78 to -0.33	-0.83 Units on a Scale Interval -1.55 to -0.11
Change From Baseline in NPI Individual Item Scores in Acute Phase: Aberrant Motor Behavior Week 10	-1.02 Units on a Scale Interval -1.83 to -0.22	-0.89 Units on a Scale Interval -1.69 to -0.09

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=103 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change From Baseline in NPI Individual Item Scores in Acute Phase: Appetite/Eating Behaviors Baseline (Day 0)	1.78 Units on a Scale Interval 1.18 to 2.39	1.47 Units on a Scale Interval 0.87 to 2.07
Change From Baseline in NPI Individual Item Scores in Acute Phase: Appetite/Eating Behaviors Week 1	-0.24 Units on a Scale Interval -0.73 to 0.25	-0.18 Units on a Scale Interval -0.66 to 0.3
Change From Baseline in NPI Individual Item Scores in Acute Phase: Appetite/Eating Behaviors Week 2	-0.36 Units on a Scale Interval -0.84 to 0.12	-0.21 Units on a Scale Interval -0.68 to 0.26
Change From Baseline in NPI Individual Item Scores in Acute Phase: Appetite/Eating Behaviors Week 3	-0.14 Units on a Scale Interval -0.65 to 0.36	0.23 Units on a Scale Interval -0.27 to 0.73
Change From Baseline in NPI Individual Item Scores in Acute Phase: Appetite/Eating Behaviors Week 4	-0.44 Units on a Scale Interval -0.96 to 0.07	-0.04 Units on a Scale Interval -0.55 to 0.47
Change From Baseline in NPI Individual Item Scores in Acute Phase: Appetite/Eating Behaviors Week 6	-0.27 Units on a Scale Interval -0.96 to 0.42	0.23 Units on a Scale Interval -0.45 to 0.91
Change From Baseline in NPI Individual Item Scores in Acute Phase: Appetite/Eating Behaviors Week 8	-0.11 Units on a Scale Interval -0.72 to 0.49	0.45 Units on a Scale Interval -0.15 to 1.05
Change From Baseline in NPI Individual Item Scores in Acute Phase: Appetite/Eating Behaviors Week 10	-0.17 Units on a Scale Interval -0.79 to 0.46	0.56 Units on a Scale Interval -0.05 to 1.17

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=103 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change From Baseline in NPI Individual Item Scores in Acute Phase: Sleep Baseline (Day 0)	2.67 Units on a Scale Interval 1.78 to 3.55	3.03 Units on a Scale Interval 2.15 to 3.91
Change From Baseline in NPI Individual Item Scores in Acute Phase: Sleep Week 1	-0.10 Units on a Scale Interval -0.84 to 0.64	-0.07 Units on a Scale Interval -0.81 to 0.67
Change From Baseline in NPI Individual Item Scores in Acute Phase: Sleep Week 2	-0.20 Units on a Scale Interval -0.95 to 0.55	-0.07 Units on a Scale Interval -0.82 to 0.67
Change From Baseline in NPI Individual Item Scores in Acute Phase: Sleep Week 3	-0.20 Units on a Scale Interval -0.98 to 0.58	0.10 Units on a Scale Interval -0.68 to 0.87
Change From Baseline in NPI Individual Item Scores in Acute Phase: Sleep Week 4	0.02 Units on a Scale Interval -0.65 to 0.7	0.15 Units on a Scale Interval -0.53 to 0.82
Change From Baseline in NPI Individual Item Scores in Acute Phase: Sleep Week 6	-0.39 Units on a Scale Interval -1.12 to 0.34	-0.03 Units on a Scale Interval -0.76 to 0.69
Change From Baseline in NPI Individual Item Scores in Acute Phase: Sleep Week 8	-0.06 Units on a Scale Interval -0.8 to 0.68	-0.06 Units on a Scale Interval -0.79 to 0.68
Change From Baseline in NPI Individual Item Scores in Acute Phase: Sleep Week 10	0.05 Units on a Scale Interval -0.69 to 0.79	-0.06 Units on a Scale Interval -0.8 to 0.67

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 2, 4, and 10

Population: Observed cases data set, Efficacy Sample. n=Participants who had both post baseline and baseline values. Of the 208 randomized participants, 5 were excluded from the efficacy data set: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)

The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50.(lower score=less severe). Negative change scores indicate improvement.

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=103 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change From Baseline in Simpson-Angus Scale (SAS) Total Score in Acute Phase Baseline (Day 0); n=97, 100	14.41 Units on scale 95% Confidence Interval NA • Interval 13.37 to 15.46	14.47 Units on scale 95% Confidence Interval NA • Interval 13.45 to 15.5
Change From Baseline in Simpson-Angus Scale (SAS) Total Score in Acute Phase Week 2; n=89, 94	0.02 Units on scale Interval -0.49 to 0.52	-0.35 Units on scale Interval -0.84 to 0.14
Change From Baseline in Simpson-Angus Scale (SAS) Total Score in Acute Phase Week 4; n=93, 96	-0.15 Units on scale Interval -0.76 to 0.45	-0.06 Units on scale Interval -0.65 to 0.54
Change From Baseline in Simpson-Angus Scale (SAS) Total Score in Acute Phase Week 10; n=82, 85	-0.44 Units on scale Interval -1.19 to 0.31	0.33 Units on scale Interval -0.4 to 1.07

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 2, 4, 8, and 10

Population: Observed Cased data set, efficacy sample. n=Participants who had both post baseline and baseline values. Of the 208 randomized participants, 5 were excluded from the efficacy data set: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)

The Abnormal Involuntary Movement Scale (AIMS) is a rating scale that was designed to measure involuntary movements (tardive dyskinesia). The AIMS test has a total of twelve items rating involuntary movements of various areas of the patient's body. These items are rated on a five-point scale of severity from 0-4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). AIMS Total Score is from 0 to 28. A negative change score signifies improvement.

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=103 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score in Acute Phase Baseline (Day 0); n=99, 101	0.87 Units on scale Interval 0.32 to 1.42	0.93 Units on scale Interval 0.39 to 1.48
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score in Acute Phase Week 2; n=91, 95	-0.10 Units on scale Interval -0.25 to 0.04	-0.17 Units on scale Interval -0.32 to -0.03
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score in Acute Phase Week 4; n=97, 97	-0.05 Units on scale Interval -0.3 to 0.19	-0.08 Units on scale Interval -0.33 to 0.17
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score in Acute Phase Week 8; n=87, 87	0.07 Units on scale Interval -0.3 to 0.44	-0.14 Units on scale Interval -0.51 to 0.23
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score in Acute Phase Week 10; n=85, 87	0.05 Units on scale Interval -0.33 to 0.43	-0.17 Units on scale Interval -0.55 to 0.2

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Population: Observed cases data set, efficacy sample. n=Participants with both post-baseline and baseline measures. Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)

The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=103 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change From Baseline in Barnes Global Clinical Assessment of Akathisia in Acute Phase Baseline (Day 0); n=100,101	0.20 Unit on scale Interval 0.09 to 0.31	0.19 Unit on scale Interval 0.07 to 0.3
Change From Baseline in Barnes Global Clinical Assessment of Akathisia in Acute Phase Week 1; n=99, 101	-0.06 Unit on scale Interval -0.12 to 0.0	-0.06 Unit on scale Interval -0.12 to 0.0
Change From Baseline in Barnes Global Clinical Assessment of Akathisia in Acute Phase Week 2; n=91, 95	-0.02 Unit on scale Interval -0.07 to 0.03	-0.05 Unit on scale Interval -0.11 to 0.0
Change From Baseline in Barnes Global Clinical Assessment of Akathisia in Acute Phase Week 3; n=95, 99	-0.03 Unit on scale Interval -0.08 to 0.02	-0.06 Unit on scale Interval -0.11 to -0.01
Change From Baseline in Barnes Global Clinical Assessment of Akathisia in Acute Phase Week 4; n=97, 98	0.00 Unit on scale 95% Confidence Interval NA • Interval -0.07 to 0.07	-0.08 Unit on scale Interval -0.15 to -0.02
Change From Baseline in Barnes Global Clinical Assessment of Akathisia in Acute Phase Week 6; n=91, 92	-0.07 Unit on scale Interval -0.14 to -0.01	-0.02 Unit on scale Interval -0.09 to 0.04
Change From Baseline in Barnes Global Clinical Assessment of Akathisia in Acute Phase Week 8; n=87, 87	-0.05 Unit on scale Interval -0.11 to 0.01	-0.03 Unit on scale Interval -0.09 to 0.03
Change From Baseline in Barnes Global Clinical Assessment of Akathisia in Acute Phase Week 10; n=85, 87	-0.05 Unit on scale Interval -0.11 to 0.0	-0.05 Unit on scale Interval -0.11 to 0.01

SECONDARY outcome

Timeframe: Week 1 to week 10

Population: Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication.

Extrapyramidal symptoms (EPS) are various movement disorders such as acute dystonic reactions, pseudoparkinsonism, or akathisia

Outcome measures

Outcome measures
Measure	Placebo n=102 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=105 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events in Acute Phase Dyskinesia	2 Participants	0 Participants
Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events in Acute Phase Extrapyramidal syndrome	1 Participants	2 Participants
Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events in Acute Phase Hypertonia	1 Participants	1 Participants
Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events in Acute Phase Hypokinesia	0 Participants	1 Participants
Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events in Acute Phase Tremor	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Week 1 to week 10

Population: Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication.

AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.

Outcome measures

Outcome measures
Measure	Placebo n=102 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=105 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs in Acute Phase Any adverse event (AE)	53 Participants	67 Participants
Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs in Acute Phase Serious adverse event	9 Participants	16 Participants
Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs in Acute Phase Deaths	0 Participants	4 Participants
Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs in Acute Phase Discontinuations due to AE	7 Participants	11 Participants

SECONDARY outcome

Timeframe: Week 1 to Week 10

Population: Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication. n=Participants with values for laboratory findings

Criteria for identifying potentially clinically significant laboratory values were based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products. Normal ranges are local lab data and vary according to the site. M=male, F=female. Criteria for hematocrit also includes a 3 point shift from baseline.

Outcome measures

Outcome measures
Measure	Placebo n=102 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=105 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase Alanine aminotransferase ≥3 x ULN; n=98, 98	1 Participants	3 Participants
Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase Aspartate aminotransferase ≥3 x ULN; n=98, 98	1 Participants	1 Participants
Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase Alkaline phosphatase ≥3 x ULN; n=98, 98	1 Participants	0 Participants
Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase Creatine phosphokinase (total) ≥3 x ULN; n=98, 98	1 Participants	2 Participants
Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase Creatinine ≥ 2.0 mg/dL; n=98, 98	2 Participants	2 Participants
Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase Uric acid ≥8.5 mg/dL (F);≥10.5 mg/dL(M); n=98, 98	5 Participants	2 Participants
Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase Calcium ≥ 10.6 mg/dL; n=98, 98	1 Participants	2 Participants
Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase Calcium ≤ 8.4 mg/dL; n=98, 98	4 Participants	5 Participants
Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase Serum Chloride ≥ 113 mEq/L; n=98, 98	6 Participants	4 Participants
Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase Serum Chloride ≤ 93 mEq/L; n=98, 98	5 Participants	6 Participants
Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase Cholesterol Total > ULN; n=98, 98	47 Participants	36 Participants
Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase Cholesterol Total < LLN; n=98, 98	1 Participants	0 Participants
Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase Serum Glucose Fasting > ULN; n=36, 31	13 Participants	16 Participants
Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase Serum Potassium ≥ 5.6 mEq/L; n=98, 98	7 Participants	7 Participants
Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase Serum Potassium ≤ 3.4 mEq/L; n=98, 98	4 Participants	4 Participants
Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase Serum Sodium ≥ 148 mEq/L; n=98, 98	2 Participants	1 Participants
Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase Serum Sodium ≤ 132 mEq/L; n=98, 98	3 Participants	3 Participants
Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase Urea ≥ 10.1mmol/L; n=98, 97	19 Participants	14 Participants
Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase Platelet ≥ 700,000 mm3; n=97, 96	0 Participants	1 Participants
Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase Platelet ≤ 75,000 mm3; n=97, 96	1 Participants	0 Participants
Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase Eosinophils ≥ 10%; n=97, 96	1 Participants	1 Participants
Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase Hematocrit ≤ 37% (M)/≤ 32% (F); n=97, 96	7 Participants	6 Participants
Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase Hemoglobin ≤ 11.5 (M)/≤ 9.5 g/dL (F); n=97, 96	6 Participants	4 Participants
Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase Urine Glucose ≥ 2-unit increase; n=92, 93	2 Participants	0 Participants
Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase Urine Protein ≥ 2-unit increase; n=92, 93	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 1 to week 10

Systolic BP: increase defined as ≥180 and a ≥20-mmHg increase from baseline (BL); decrease defined as ≤90 and a ≥20mmHg decrease from BL. Diastolic BP: increase defined as ≥105 and a ≥15mmHg decrease from BL, decrease defined as ≤50 and a ≥15mmHg decrease from BL. Heart rate: increase defined as ≥120 and ≥15bpm increase from BL, decrease defined as ≤50 and ≥15bpm decrease from BL; Weight: increase defined as ≥7% from BL, decrease defined as ≤7% decrease BL. Criteria for identifying PCS measurements are based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products

Outcome measures

Outcome measures
Measure	Placebo n=102 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=105 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Participants With Potentially Clinically Significant (PCS) Vital Sign Abnormalities in Acute Phase Increased Systolic BP, standing; n=99, 100	5 Participants	5 Participants
Participants With Potentially Clinically Significant (PCS) Vital Sign Abnormalities in Acute Phase Decreased Systolic BP, standing; n=99, 100	1 Participants	1 Participants
Participants With Potentially Clinically Significant (PCS) Vital Sign Abnormalities in Acute Phase Increased Systolic BP, supine; n=101, 102	6 Participants	2 Participants
Participants With Potentially Clinically Significant (PCS) Vital Sign Abnormalities in Acute Phase Decreased Systolic BP, supine; n=101, 102	0 Participants	2 Participants
Participants With Potentially Clinically Significant (PCS) Vital Sign Abnormalities in Acute Phase Decreased Systolic BP, sitting; n=13, 20	0 Participants	1 Participants
Participants With Potentially Clinically Significant (PCS) Vital Sign Abnormalities in Acute Phase Increased Diastolic BP, standing; n=99, 100	2 Participants	2 Participants
Participants With Potentially Clinically Significant (PCS) Vital Sign Abnormalities in Acute Phase Decreased Diastolic BP, standing; n=99, 100	6 Participants	3 Participants
Participants With Potentially Clinically Significant (PCS) Vital Sign Abnormalities in Acute Phase Increased Diastolic BP, supine; n=101, 102	2 Participants	0 Participants
Participants With Potentially Clinically Significant (PCS) Vital Sign Abnormalities in Acute Phase Decreased Diastolic BP, supine; n=101, 102	4 Participants	3 Participants
Participants With Potentially Clinically Significant (PCS) Vital Sign Abnormalities in Acute Phase Decreased Diastolic BP, sitting; n=13, 20	2 Participants	0 Participants
Participants With Potentially Clinically Significant (PCS) Vital Sign Abnormalities in Acute Phase Increased Heart rate, standing; n=99, 100	1 Participants	0 Participants
Participants With Potentially Clinically Significant (PCS) Vital Sign Abnormalities in Acute Phase Decreased Heart rate, standing; n=99, 100	0 Participants	1 Participants
Participants With Potentially Clinically Significant (PCS) Vital Sign Abnormalities in Acute Phase Decreased Heart rate, supine; n=101, 102	1 Participants	3 Participants
Participants With Potentially Clinically Significant (PCS) Vital Sign Abnormalities in Acute Phase Increased Weight; n=89, 93	3 Participants	5 Participants
Participants With Potentially Clinically Significant (PCS) Vital Sign Abnormalities in Acute Phase Decreased Weight; n=89,93	5 Participants	5 Participants

SECONDARY outcome

Timeframe: Week 1 to Week 10

Bradycardia:Heart rate ≤50 bpm and ≥15 bpm decrease from baseline; Supraventricular premature beat: ≥2 per 10 seconds and any increase from baseline; 1st degree A-V Block: PR ≥0.20 seconds and increase of ≥0.05 second from baseline; Intraventricular conduction block:QRS ≥0.12 second and increase of ≥0.02 second from baseline; QTcB= ≥450 msec and ≥10% increase from baseline; QTcN =≥450 msec and ≥10% increase from baseline. All other events were not present at baseline but observed during the study. Inc=increase

Outcome measures

Outcome measures
Measure	Placebo n=102 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole n=105 Participants Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase Bradycardia; n=99, 102	3 Participants	1 Participants
Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase Sinus Bradycardia; n=99, 102	2 Participants	1 Participants
Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase Supraventricular premature beat; n=99, 102	10 Participants	7 Participants
Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase Ventricular premature beat; n=99, 102	7 Participants	12 Participants
Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase Supraventricular tachycardia; n=99, 102	1 Participants	0 Participants
Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase Atrial fibrillation; n=99, 102	3 Participants	1 Participants
Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase Atrial flutter; n=99, 102	0 Participants	1 Participants
Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase 1st degree A-V Block; n=95, 97	2 Participants	0 Participants
Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase Left bundle branch block; n=99, 102	1 Participants	2 Participants
Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase Right bundle branch block; n=99, 102	2 Participants	1 Participants
Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase Other intraventricular conduction block; n=99, 102	0 Participants	2 Participants
Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase Subacute infarction; n=99, 102	1 Participants	0 Participants
Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase Old infarction; n=99, 102	2 Participants	2 Participants
Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase Myocardial ischemia; n=99, 102	3 Participants	4 Participants
Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase Symmetrical T-wave inversion; n=99, 102	2 Participants	1 Participants
Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase Inc QTcB (≥450 msec≥,10% from baseline); n=99, 102	5 Participants	5 Participants
Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase Inc QTcN (≥450 msec,≥10% from baseline); n=99, 102	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 18,26,40,52,68,84,100,116,132,140

Population: Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values Of the 161 participants (80 in placebo and 81 in aripiprazole group), 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements).

Outcome measures

Outcome measures
Measure	Placebo n=158 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score From Baseline During Extension Phase Baseline, Day 0 (n=154)	12.312 Units on a Scale Standard Error 0.426	—
Change in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score From Baseline During Extension Phase Week 18 (n=151)	-8.589 Units on a Scale Standard Error 0.548	—
Change in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score From Baseline During Extension Phase Week 26 (n=139)	-8.993 Units on a Scale Standard Error 0.589	—
Change in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score From Baseline During Extension Phase Week 40 (n=115)	-8.270 Units on a Scale Standard Error 0.677	—
Change in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score From Baseline During Extension Phase Week 52 (n=98)	-8.582 Units on a Scale Standard Error 0.672	—
Change in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score From Baseline During Extension Phase Week 68 (n=69)	-9.232 Units on a Scale Standard Error 0.824	—
Change in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score From Baseline During Extension Phase Week 84 (n=62)	-10.18 Units on a Scale Standard Error 0.848	—
Change in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score From Baseline During Extension Phase Week 100 (n=52)	-10.06 Units on a Scale Standard Error 1.031	—
Change in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score From Baseline During Extension Phase Week 116 (n=47)	-10.19 Units on a Scale Standard Error 1.183	—
Change in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score From Baseline During Extension Phase Week 132 (n=31)	-11.68 Units on a Scale Standard Error 1.554	—
Change in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score From Baseline During Extension Phase Week 140 (n=25)	-13.12 Units on a Scale Standard Error 1.586	—

SECONDARY outcome

Timeframe: Weeks 12, 14, 18, 22, 26, 30, 34, 40, 46, 52, 68, 84, 100, 116, 132, 140

Population: Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values. Of the 161 participants, 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements).

Outcome measures

Outcome measures
Measure	Placebo n=158 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Clinical Global Impression (CGI) Improvement Score During Extension Phase Week 12; n=158	2.873 Units on Scale Standard Error 0.089	—
Clinical Global Impression (CGI) Improvement Score During Extension Phase Week 14; n=151	2.709 Units on Scale Standard Error 0.084	—
Clinical Global Impression (CGI) Improvement Score During Extension Phase Week 18; n=152	2.625 Units on Scale Standard Error 0.091	—
Clinical Global Impression (CGI) Improvement Score During Extension Phase Week 22; n=145	2.552 Units on Scale Standard Error 0.087	—
Clinical Global Impression (CGI) Improvement Score During Extension Phase Week 26; n=140	2.707 Units on Scale Standard Error 0.113	—
Clinical Global Impression (CGI) Improvement Score During Extension Phase Week 30; n=129	2.636 Units on Scale Standard Error 0.113	—
Clinical Global Impression (CGI) Improvement Score During Extension Phase Week 34; n=121	2.554 Units on Scale Standard Error 0.106	—
Clinical Global Impression (CGI) Improvement Score During Extension Phase Week 40; n=114	2.482 Units on Scale Standard Error 0.121	—
Clinical Global Impression (CGI) Improvement Score During Extension Phase Week 46; n=103	2.592 Units on Scale Standard Error 0.130	—
Clinical Global Impression (CGI) Improvement Score During Extension Phase Week 52; n=100	2.580 Units on Scale Standard Error 0.138	—
Clinical Global Impression (CGI) Improvement Score During Extension Phase Week 68; n=70	2.514 Units on Scale Standard Error 0.155	—
Clinical Global Impression (CGI) Improvement Score During Extension Phase Week 84; n=62	2.306 Units on Scale Standard Error 0.150	—
Clinical Global Impression (CGI) Improvement Score During Extension Phase Week 100; n=53	2.660 Units on Scale Standard Error 0.196	—
Clinical Global Impression (CGI) Improvement Score During Extension Phase Week 116; n=47	2.787 Units on Scale Standard Error 0.233	—
Clinical Global Impression (CGI) Improvement Score During Extension Phase Week 132; n=36	3.028 Units on Scale Standard Error 0.289	—
Clinical Global Impression (CGI) Improvement Score During Extension Phase Week 140; n=26	2.385 Units on Scale Standard Error 0.299	—

SECONDARY outcome

Timeframe: End of Acute Phase (Week 10), Weeks 14, 18, 22, 26, 30, 34, 40, 46, 52, 68, 84, 100, 116, 140

Population: Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values. Of the 161 participants (80 in placebo and 81 in aripiprazole group), 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements).

AIMS is a rating scale that was designed to measure involuntary movements (tardive dyskinesia). The AIMS test has a total of twelve items rating involuntary movements of various areas of the patient's body. These items are rated on a five-point scale of severity from 0-4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). AIMS Total Score is from 0 to 28. A negative change score signifies improvement.

Outcome measures

Outcome measures
Measure	Placebo n=158 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase End of Acute Phase (Week 10); n=157	0.95 Units on Scale Standard Error 0.20	—
Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase Week 14; n=151	0.25 Units on Scale Standard Error 0.12	—
Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase Week 18; n=152	0.09 Units on Scale Standard Error 0.11	—
Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase Week 22; n=145	0.02 Units on Scale Standard Error 0.13	—
Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase Week 26; n=140	-0.12 Units on Scale Standard Error 0.13	—
Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase Week 30; n=128	-0.01 Units on Scale Standard Error 0.10	—
Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase Week 34; n=121	-0.10 Units on Scale Standard Error 0.15	—
Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase Week 40; n=115	-0.01 Units on Scale Standard Error 0.16	—
Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase Week 46; n=104	-0.02 Units on Scale Standard Error 0.15	—
Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase Week 52; n=100	-0.02 Units on Scale Standard Error 0.20	—
Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase Week 68; n=70	-0.29 Units on Scale Standard Error 0.17	—
Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase Week 84; n=62	-0.24 Units on Scale Standard Error 0.17	—
Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase Week 100; n=52	-0.21 Units on Scale Standard Error 0.15	—
Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase Week 116; n=47	-0.21 Units on Scale Standard Error 0.20	—
Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase Week 140; n=15	0.00 Units on Scale Standard Error 0.20	—
Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase Endpoint (LOCF data set); n=157	-0.03 Units on Scale Standard Error 0.15	—

SECONDARY outcome

Timeframe: End of Acute Phase (Week 10), Weeks 18,26, 40, 52

The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50 (lower score=less severe). Negative change scores indicate improvement.

Outcome measures

Outcome measures
Measure	Placebo n=158 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change in Simpson-Angus Scale (SAS) Total Score During Extension Phase End of Acute Phase (Week 10); n=153	14.34 Units on Scale Standard Error 0.40	—
Change in Simpson-Angus Scale (SAS) Total Score During Extension Phase Week 18; n=148	0.62 Units on Scale Standard Error 0.23	—
Change in Simpson-Angus Scale (SAS) Total Score During Extension Phase Week 26; n=132	1.24 Units on Scale Standard Error 0.31	—
Change in Simpson-Angus Scale (SAS) Total Score During Extension Phase Week 40; n=107	1.25 Units on Scale Standard Error 0.39	—
Change in Simpson-Angus Scale (SAS) Total Score During Extension Phase Week 52; n=95	1.14 Units on Scale Standard Error 0.40	—
Change in Simpson-Angus Scale (SAS) Total Score During Extension Phase Endpoint (LOCF data set); n=153	2.01 Units on Scale Standard Error 0.37	—

SECONDARY outcome

Timeframe: End of Acute Phase (Week 10), Weeks 18,26, 40, 52

Outcome measures

Outcome measures
Measure	Placebo n=158 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Change in Barnes Global Clinical Assessment of Akathisia Score During Extension Phase End of Acute Phase (Week 10); n=155	0.14 units on a scale Standard Error 0.03	—
Change in Barnes Global Clinical Assessment of Akathisia Score During Extension Phase Week 18; n=151	0.04 units on a scale Standard Error 0.03	—
Change in Barnes Global Clinical Assessment of Akathisia Score During Extension Phase Week 26; n=139	0.03 units on a scale Standard Error 0.04	—
Change in Barnes Global Clinical Assessment of Akathisia Score During Extension Phase Week 40; n=114	0.04 units on a scale Standard Error 0.04	—
Change in Barnes Global Clinical Assessment of Akathisia Score During Extension Phase Week 52; n=99	0.06 units on a scale Standard Error 0.03	—
Change in Barnes Global Clinical Assessment of Akathisia Score During Extension Phase Endpoint (LOCF data set); n=155	0.06 units on a scale Standard Error 0.03	—

SECONDARY outcome

Timeframe: Week 11 to Week 140

Population: All the 161 participants (80 in placebo and 81 in aripiprazole group)were included in the Extension Phase Safety Sample.

Extrapyramidal symptoms (EPS) are various movement disorders such as acute dystonic reactions, pseudoparkinsonism, or akathisia

Outcome measures

Outcome measures
Measure	Placebo n=161 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events During Extension Phase Dyskinesia	2 Participants	—
Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events During Extension Phase Muscle Rigidity	3 Participants	—
Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events During Extension Phase Extrapyramidal Disorder	14 Participants	—
Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events During Extension Phase Hypokinesia	8 Participants	—
Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events During Extension Phase Tremor	8 Participants	—
Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events During Extension Phase Akinesia	1 Participants	—
Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events During Extension Phase Bradykinesia	1 Participants	—
Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events During Extension Phase Parkinsonian Gait	1 Participants	—
Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events During Extension Phase Muscle Twitching	1 Participants	—

SECONDARY outcome

Timeframe: Week 11 to Week 140

Population: All the 161 participants (80 in placebo and 81 in aripiprazole group)were included in the Extension Phase Safety Sample.

Outcome measures

Outcome measures
Measure	Placebo n=161 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Extension Phase Death	41 Participants	—
Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Extension Phase SAE	59 Participants	—
Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Extension Phase AE	148 Participants	—
Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Extension Phase Discontinuation due to AE	66 Participants	—

SECONDARY outcome

Timeframe: Week 11 to Week 140

Population: All the 161 participants (80 in placebo and 81 in aripiprazole group) were included in the Extension Phase Safety Sample.

Systolic BP: increase defined as ≥180 and a ≥20-mmHg increase from baseline (BL); decrease defined as ≤90 and a ≤20mmHg decrease from BL. Diastolic BP: increase defined as ≥105 and a ≥15mmHg decrease from BL, decrease defined as ≤50 and a ≤15mmHg decrease from BL. Heart rate: increase defined as ≥120 and ≥15bpm increase from bBL, decrease defined as ≤50 and ≤15bpm decrease from BL; Weight: increase defined as ≥7% from baseline, decrease defined as ≤7% decrease BL. Criteria for identifying PCS measurements based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products

Outcome measures

Outcome measures
Measure	Placebo n=161 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase Increased Systolic BP, standing; n=159	6 Participants	—
Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase Decreased Systolic BP, standing; n=159	9 Participants	—
Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase Increased Systolic BP, supine; n=158	6 Participants	—
Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase Decreased Systolic BP, supine; n=158	7 Participants	—
Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase Decreased Systolic BP, sitting; n=45	1 Participants	—
Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase Increased Diastolic BP, standing; n=159	4 Participants	—
Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase Decreased Diastolic BP, standing; n=159	19 Participants	—
Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase Increased Diastolic BP, supine; n=158	1 Participants	—
Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase Decreased Diastolic BP, sitting; n=45	1 Participants	—
Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase Increased Heart rate, standing; n=159	2 Participants	—
Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase Decreased Heart rate, standing; n=159	3 Participants	—
Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase Increased Heart rate, supine; n=158	1 Participants	—
Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase Decreased Heart rate, supine; n=158	5 Participants	—
Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase Increased Weight; n=133	28 Participants	—
Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase Decreased Weight; n=133	58 Participants	—
Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase Decreased Diastolic BP, supine; n=158	25 Participants	—

SECONDARY outcome

Timeframe: Week 11 to Week 140

Population: All the 161 participants (80 in placebo and 81 in aripiprazole group) were included in the Extension Phase Safety Sample.

Outcome measures

Outcome measures
Measure	Placebo n=161 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Participants With a Potentially Clinically Significant Electrocardiogram Abnormalities During Extension Phase Atrial Fibrillation; n=145	5 Participants	—
Participants With a Potentially Clinically Significant Electrocardiogram Abnormalities During Extension Phase Atrial Flutter; n=145	1 Participants	—
Participants With a Potentially Clinically Significant Electrocardiogram Abnormalities During Extension Phase Bradycardia; n=145	4 Participants	—
Participants With a Potentially Clinically Significant Electrocardiogram Abnormalities During Extension Phase Left Bundle Branch Block; n=145	5 Participants	—
Participants With a Potentially Clinically Significant Electrocardiogram Abnormalities During Extension Phase Myocardial Ischemia; n=145	10 Participants	—
Participants With a Potentially Clinically Significant Electrocardiogram Abnormalities During Extension Phase Old Infarction; n=145	2 Participants	—
Participants With a Potentially Clinically Significant Electrocardiogram Abnormalities During Extension Phase Right Bundle Branch Block; n=145	3 Participants	—
Participants With a Potentially Clinically Significant Electrocardiogram Abnormalities During Extension Phase Sinus Bradycardia; n=145	2 Participants	—
Participants With a Potentially Clinically Significant Electrocardiogram Abnormalities During Extension Phase Sinus Tachycardia; n=145	2 Participants	—
Participants With a Potentially Clinically Significant Electrocardiogram Abnormalities During Extension Phase Supraventricular Premature Beat; n=145	12 Participants	—
Participants With a Potentially Clinically Significant Electrocardiogram Abnormalities During Extension Phase Supraventricular Tachycardia; n=145	2 Participants	—
Participants With a Potentially Clinically Significant Electrocardiogram Abnormalities During Extension Phase Symmetrical T-wave Inversions; n=145	8 Participants	—
Participants With a Potentially Clinically Significant Electrocardiogram Abnormalities During Extension Phase Tachycardia; n=145	4 Participants	—
Participants With a Potentially Clinically Significant Electrocardiogram Abnormalities During Extension Phase Ventricular premature Beat; n=145	13 Participants	—

SECONDARY outcome

Timeframe: Week 11 to Week 140

Population: All the 161 participants (80 in placebo and 81 in aripiprazole group) were included in the Extension Phase Safety Sample.

Criteria for identifying potentially clinically significant laboratory values were based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products.

Outcome measures

Outcome measures
Measure	Placebo n=161 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase High Alanine aminotransferase; ≥ 41 U/L	0 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase High Aspartate aminotransferase; ≥ 38 U/L	1 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase High Alkaline phosphatase; ≥ 117 U/L	2 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase High Lactate dehydrogenase; >480 U/L	1 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase High Urea; >8.4 mmol/L	56 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase High Creatinine; ≥ 2.0 mg/dL	8 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase High Uric acid; >5.7 mg/dL	9 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase High Total Billirubin; > 1 mg/dL	0 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase High Creatinine Kinase; ≥ 170 U/L	2 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase High Serum Glucose Fasting; >118 mg/dL	36 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase High Serum Glucose Non-fasting; >118 mg/dL	17 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase High Cholesterol Total; > 220mg/dL	131 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase High Serum Calcium; >10.2 mg/dL	5 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase Low Serum Calcium; <8.6 mg/dL	26 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase High Serum Chloride; >108 mEq/L	24 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase Low Serum Chloride; <96 mEq/L	36 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase High Serum Potassium; >5.1 mEq/L	36 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase Low Serum Potassium; <3.3mEq/L	11 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase High Serum Sodium; > 145 mEq/L	13 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase Low Serum Sodium; < 133 mEq/L	12 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase Low Hematocrit; <37%	21 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase Low Hemoglobin; < 12 g/dL	19 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase High Leukocyte count; > 10.8 x 10^3 c/uL	7 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase Low Leukocyte count: < 4.8 x 10^3 c/uL	4 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase High Eosinophil count; > 5%	3 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase High Platelet count; >450 x 10^9 c/L	0 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase Low Platelet count; < 150 x 10^9 c/L	1 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase High Urine Protein; ≥ 2-unit increase	2 Participants	—
Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase High Urine Glucose; ≥ 2-unit increase	3 Participants	—

SECONDARY outcome

Timeframe: Week 140 to Week 328

Population: Participants in France who completed the 130-week open-label extension phase and continued beyond Week 140 were included in safety sample.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Acute Phase: 0 mg, Once daily (10 Weeks	Aripiprazole Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Treatment Beyond 140 Weeks Any AE	7 Participants	—
Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Treatment Beyond 140 Weeks SAE	1 Participants	—
Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Treatment Beyond 140 Weeks Death	1 Participants	—
Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Treatment Beyond 140 Weeks Discontinuation due to AE	3 Participants	—

Adverse Events

1 Double Blind Aripiprazole

Serious events: 16 serious events

Other events: 31 other events

Deaths: 0 deaths

2 Double Blind Placebo

Serious events: 8 serious events

Other events: 27 other events

Deaths: 0 deaths

3 Ext - Aripiprazole

Serious events: 84 serious events

Other events: 101 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	1 Double Blind Aripiprazole n=105 participants at risk	2 Double Blind Placebo n=102 participants at risk	3 Ext - Aripiprazole n=161 participants at risk
Respiratory, thoracic and mediastinal disorders ACQUIRED DIAPHRAGMATIC EVENTRATION	0.00% 0/105	0.00% 0/102	0.62% 1/161
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY DISTRESS SYNDROME	0.00% 0/105	0.00% 0/102	0.62% 1/161
Cardiac disorders CARDIOVASCULAR INSUFFICIENCY	0.00% 0/105	0.00% 0/102	0.62% 1/161
General disorders DEATH	1.9% 2/105	0.00% 0/102	2.5% 4/161
Nervous system disorders DIABETIC COMA	0.00% 0/105	0.00% 0/102	0.62% 1/161
Skin and subcutaneous tissue disorders ECZEMA VESICULAR	0.00% 0/105	0.00% 0/102	0.62% 1/161
Infections and infestations ESCHERICHIA SEPSIS	0.00% 0/105	0.00% 0/102	0.62% 1/161
Injury, poisoning and procedural complications FEMUR FRACTURE	0.00% 0/105	0.00% 0/102	2.5% 4/161
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.00% 0/105	0.00% 0/102	0.62% 1/161
Respiratory, thoracic and mediastinal disorders LUNG DISORDER	0.00% 0/105	0.00% 0/102	3.1% 5/161
Musculoskeletal and connective tissue disorders MUSCLE RIGIDITY	0.00% 0/105	0.00% 0/102	0.62% 1/161
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL STIFFNESS	0.00% 0/105	0.00% 0/102	0.62% 1/161
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.00% 0/105	0.00% 0/102	0.62% 1/161
Gastrointestinal disorders SALIVARY HYPERSECRETION	0.95% 1/105	0.00% 0/102	0.00% 0/161
Infections and infestations SEPSIS	0.00% 0/105	0.00% 0/102	1.9% 3/161
Renal and urinary disorders URINARY RETENTION	0.00% 0/105	0.00% 0/102	0.62% 1/161
Infections and infestations URINARY TRACT INFECTION	0.00% 0/105	0.00% 0/102	1.2% 2/161
Respiratory, thoracic and mediastinal disorders BRONCHOPNEUMOPATHY	0.00% 0/105	0.00% 0/102	0.62% 1/161
Vascular disorders CIRCULATORY COLLAPSE	0.00% 0/105	0.00% 0/102	0.62% 1/161
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/105	0.00% 0/102	1.9% 3/161
Injury, poisoning and procedural complications FALL	0.95% 1/105	0.98% 1/102	0.62% 1/161
Blood and lymphatic system disorders LEUKOPENIA	0.00% 0/105	0.00% 0/102	0.62% 1/161
Vascular disorders PERIPHERAL ISCHAEMIA	0.00% 0/105	0.00% 0/102	0.62% 1/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.00% 0/105	0.00% 0/102	0.62% 1/161
Infections and infestations PYELONEPHRITIS	0.00% 0/105	0.00% 0/102	1.2% 2/161
Nervous system disorders DEMENTIA ALZHEIMER'S TYPE	0.00% 0/105	0.00% 0/102	0.62% 1/161
Nervous system disorders EPILEPSY	0.00% 0/105	0.98% 1/102	0.00% 0/161
Infections and infestations ERYSIPELAS	0.00% 0/105	0.00% 0/102	0.62% 1/161
Gastrointestinal disorders FAECALOMA	0.00% 0/105	0.00% 0/102	0.62% 1/161
Hepatobiliary disorders HEPATITIS ACUTE	0.00% 0/105	0.00% 0/102	0.62% 1/161
Infections and infestations INFECTION	0.00% 0/105	0.00% 0/102	0.62% 1/161
Gastrointestinal disorders INTESTINAL OBSTRUCTION	0.00% 0/105	0.00% 0/102	0.62% 1/161
Injury, poisoning and procedural complications JAW FRACTURE	0.00% 0/105	0.00% 0/102	0.62% 1/161
Surgical and medical procedures PSYCHOSOCIAL SUPPORT	1.9% 2/105	0.00% 0/102	0.62% 1/161
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/105	0.00% 0/102	0.62% 1/161
Respiratory, thoracic and mediastinal disorders ACUTE PULMONARY OEDEMA	0.00% 0/105	0.00% 0/102	1.2% 2/161
General disorders ASTHENIA	0.00% 0/105	0.00% 0/102	1.2% 2/161
Cardiac disorders CARDIAC ARREST	0.00% 0/105	0.00% 0/102	6.2% 10/161
Cardiac disorders CARDIAC FAILURE ACUTE	0.00% 0/105	0.00% 0/102	0.62% 1/161
Cardiac disorders CARDIOPULMONARY FAILURE	0.00% 0/105	0.00% 0/102	0.62% 1/161
Metabolism and nutrition disorders DEHYDRATION	0.95% 1/105	0.00% 0/102	1.9% 3/161
Injury, poisoning and procedural complications HUMERUS FRACTURE	0.95% 1/105	0.00% 0/102	0.00% 0/161
Nervous system disorders ISCHAEMIC STROKE	0.00% 0/105	0.00% 0/102	0.62% 1/161
General disorders MALAISE	0.00% 0/105	0.00% 0/102	0.62% 1/161
Infections and infestations PNEUMONIA	0.00% 0/105	0.00% 0/102	1.9% 3/161
General disorders PYREXIA	0.00% 0/105	0.00% 0/102	0.62% 1/161
Renal and urinary disorders RENAL FAILURE	0.00% 0/105	0.00% 0/102	0.62% 1/161
Cardiac disorders ATRIAL FLUTTER	0.00% 0/105	0.00% 0/102	0.62% 1/161
Psychiatric disorders CONFUSIONAL STATE	0.95% 1/105	0.00% 0/102	0.62% 1/161
Gastrointestinal disorders DIARRHOEA	0.00% 0/105	0.00% 0/102	0.62% 1/161
Vascular disorders EMBOLISM	0.00% 0/105	0.00% 0/102	0.62% 1/161
Gastrointestinal disorders HAEMATEMESIS	0.00% 0/105	0.00% 0/102	0.62% 1/161
Nervous system disorders LETHARGY	0.00% 0/105	0.00% 0/102	0.62% 1/161
Cardiac disorders MYOCARDIAL INFARCTION	0.00% 0/105	0.00% 0/102	2.5% 4/161
Respiratory, thoracic and mediastinal disorders PNEUMONIA ASPIRATION	0.00% 0/105	0.00% 0/102	0.62% 1/161
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.00% 0/105	0.00% 0/102	1.2% 2/161
Infections and infestations SEPTIC SHOCK	0.95% 1/105	0.00% 0/102	0.00% 0/161
Nervous system disorders VASCULAR DEMENTIA	0.00% 0/105	0.00% 0/102	0.62% 1/161
Investigations BLOOD GLUCOSE INCREASED	0.00% 0/105	0.00% 0/102	0.62% 1/161
Infections and infestations BRONCHOPNEUMONIA	0.00% 0/105	0.00% 0/102	0.62% 1/161
Cardiac disorders CARDIAC FAILURE	0.95% 1/105	0.00% 0/102	1.2% 2/161
Cardiac disorders CARDIO-RESPIRATORY ARREST	0.00% 0/105	0.00% 0/102	1.2% 2/161
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.00% 0/105	0.00% 0/102	1.9% 3/161
Hepatobiliary disorders CHOLECYSTITIS	0.95% 1/105	0.00% 0/102	0.62% 1/161
Psychiatric disorders DELIRIUM	0.00% 0/105	0.00% 0/102	0.62% 1/161
Metabolism and nutrition disorders DIABETES MELLITUS	0.00% 0/105	0.00% 0/102	0.62% 1/161
Injury, poisoning and procedural complications FEMORAL NECK FRACTURE	1.9% 2/105	0.00% 0/102	3.7% 6/161
Injury, poisoning and procedural complications HAND FRACTURE	0.00% 0/105	0.00% 0/102	0.62% 1/161
Psychiatric disorders PSYCHOTIC DISORDER	0.00% 0/105	0.98% 1/102	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SALIVARY GLAND NEOPLASM	0.00% 0/105	0.98% 1/102	0.00% 0/161
Nervous system disorders SCIATICA	0.00% 0/105	0.00% 0/102	0.62% 1/161
Social circumstances SOCIAL PROBLEM	0.00% 0/105	0.00% 0/102	0.62% 1/161
General disorders SUDDEN CARDIAC DEATH	0.00% 0/105	0.00% 0/102	0.62% 1/161
Nervous system disorders SYNCOPE	0.00% 0/105	0.00% 0/102	1.2% 2/161
Psychiatric disorders AGGRESSION	1.9% 2/105	0.00% 0/102	0.00% 0/161
Eye disorders CATARACT	0.95% 1/105	0.98% 1/102	0.00% 0/161
Metabolism and nutrition disorders MALNUTRITION	0.00% 0/105	0.00% 0/102	0.62% 1/161
Respiratory, thoracic and mediastinal disorders RESPIRATORY ARREST	0.00% 0/105	0.00% 0/102	0.62% 1/161
Vascular disorders VARICOSE VEIN	0.95% 1/105	0.00% 0/102	0.00% 0/161
Gastrointestinal disorders VOMITING	0.00% 0/105	0.00% 0/102	0.62% 1/161
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/105	0.00% 0/102	0.62% 1/161
Blood and lymphatic system disorders ANAEMIA	0.00% 0/105	0.00% 0/102	1.2% 2/161
Cardiac disorders BRADYCARDIA	0.95% 1/105	0.98% 1/102	0.00% 0/161
Infections and infestations BRONCHITIS	0.95% 1/105	0.00% 0/102	1.9% 3/161
General disorders CHEST PAIN	0.00% 0/105	0.98% 1/102	0.00% 0/161
General disorders CHILLS	0.00% 0/105	0.00% 0/102	0.62% 1/161
Nervous system disorders DEMENTIA	0.00% 0/105	0.00% 0/102	0.62% 1/161
Injury, poisoning and procedural complications HIP FRACTURE	0.95% 1/105	0.00% 0/102	0.62% 1/161
Nervous system disorders LOSS OF CONSCIOUSNESS	0.00% 0/105	0.00% 0/102	0.62% 1/161
Infections and infestations LUNG INFECTION	0.95% 1/105	0.00% 0/102	1.9% 3/161
Respiratory, thoracic and mediastinal disorders MENDELSON'S SYNDROME	0.00% 0/105	0.00% 0/102	1.2% 2/161
Cardiac disorders MYOCARDIAL ISCHAEMIA	0.00% 0/105	0.00% 0/102	0.62% 1/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC CARCINOMA METASTATIC	0.00% 0/105	0.00% 0/102	0.62% 1/161
Injury, poisoning and procedural complications PELVIC FRACTURE	0.95% 1/105	0.00% 0/102	0.00% 0/161
Respiratory, thoracic and mediastinal disorders RESPIRATORY DISTRESS	0.00% 0/105	0.00% 0/102	0.62% 1/161
General disorders SUDDEN DEATH	0.00% 0/105	0.00% 0/102	1.2% 2/161
Vascular disorders THROMBOSIS	0.00% 0/105	0.00% 0/102	0.62% 1/161
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	0.00% 0/105	0.98% 1/102	0.00% 0/161

Other adverse events

Other adverse events
Measure	1 Double Blind Aripiprazole n=105 participants at risk	2 Double Blind Placebo n=102 participants at risk	3 Ext - Aripiprazole n=161 participants at risk
Gastrointestinal disorders CONSTIPATION	1.9% 2/105	0.00% 0/102	6.2% 10/161
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	2.9% 3/105	0.00% 0/102	6.2% 10/161
Nervous system disorders SOMNOLENCE	7.6% 8/105	2.0% 2/102	18.6% 30/161
Infections and infestations URINARY TRACT INFECTION	7.6% 8/105	13.7% 14/102	16.8% 27/161
Injury, poisoning and procedural complications FALL	2.9% 3/105	3.9% 4/102	11.2% 18/161
Psychiatric disorders INSOMNIA	1.9% 2/105	3.9% 4/102	8.7% 14/161
Psychiatric disorders ANXIETY	0.95% 1/105	2.0% 2/102	6.2% 10/161
General disorders OEDEMA PERIPHERAL	0.95% 1/105	0.00% 0/102	6.8% 11/161
Psychiatric disorders APATHY	0.00% 0/105	0.00% 0/102	8.1% 13/161
Gastrointestinal disorders DIARRHOEA	2.9% 3/105	0.98% 1/102	9.9% 16/161
Nervous system disorders EXTRAPYRAMIDAL DISORDER	1.9% 2/105	0.98% 1/102	8.7% 14/161
Gastrointestinal disorders VOMITING	0.95% 1/105	2.0% 2/102	6.2% 10/161
Infections and infestations BRONCHITIS	3.8% 4/105	2.9% 3/102	16.8% 27/161

Additional Information

BMS Study Director

Bristol-Myers Squibb

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
Publication restrictions are in place

Restriction type: OTHER