Trial Outcomes & Findings for Efficacy & Safety Study of Oral Aripiprazole in Adolescents With Schizophrenia (NCT NCT01149655)
NCT ID: NCT01149655
Last Updated: 2015-04-02
Results Overview
The primary efficacy variable was overall relapse rate from randomization, as assessed by Clinical Global Impression of Improvement (CGI-I) score ≥5, Positive and Negative Syndrome Scale (PANSS) scores for hostility or uncooperativeness ≥5, or ≥20% increase in PANSS Total Score. Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score \> 4 with an absolute increase of ≥ 2 on that specific item or absolute increase of ≥ 4 on the combined 4 PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content). OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Any suicidal behavior or answers of "yes" to Questions 4 or 5 on the suicidal ideation section of the C-SSRS OR 5) Violent or aggressive behavior resulting in clinically significant injury.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
252 participants
Primary outcome timeframe
Baseline to Week 52/End of Phase 3 visit.
Results posted on
2015-04-02
Participant Flow
A Phase 3 randomized, double-blind, placebo-controlled study consisted of screening period, conversion (Period 1), stabilization (Period 2), double-blind maintenance treatment (Period 3) and a follow-up period to evaluate efficacy and safety of aripiprazole (10-30 mg/day) compared to placebo in adolescent participants with schizophrenia.
Participants were titrated to oral aripiprazole in Period 1. Participants who converted to aripiprazole and who already received aripiprazole were in Period 2. Participants met stability criteria were randomized in 2:1 ratio (aripiprazole: placebo) in Period 3. 244 participants were screened of which 201 entered the trial and 146 were randomized.
Participant milestones
| Measure |
Aripiprazole-Conversion Phase
Participants who had received oral aripiprazole 2 to 10 mg for 2 Weeks in combination with any other antipsychotic were in conversion phase.
|
Aripiprazole-Stabilization Phase
Participants who had converted to aripiprazole monotherapy period 1 (conversion phase) and had received aripiprazole monotherapy for schizophrenia at screening were in period 2, provided the prescribed aripiprazole dose did not exceed 30 mg (milligrams) per day for 2 Weeks.
|
Aripiprazole-Double Blind (DB) Maintenance
Participants who met stability criteria in period 2 (stabilization phase) received oral aripiprazole 10 to 30 mg/day for 52 Weeks in period 3 (double-blind maintenance treatment).
|
Aripiprazole-Placebo-DB Maintenance
Participants who met stability criteria in period 2 (stabilization phase) received placebo for 52 Weeks in period 3 (double-blind maintenance treatment).
|
|---|---|---|---|---|
|
Period 1 - Conversion Phase
STARTED
|
186
|
0
|
0
|
0
|
|
Period 1 - Conversion Phase
COMPLETED
|
168
|
0
|
0
|
0
|
|
Period 1 - Conversion Phase
NOT COMPLETED
|
18
|
0
|
0
|
0
|
|
Period 2-Stabilization Phase
STARTED
|
0
|
183
|
0
|
0
|
|
Period 2-Stabilization Phase
COMPLETED
|
0
|
146
|
0
|
0
|
|
Period 2-Stabilization Phase
NOT COMPLETED
|
0
|
37
|
0
|
0
|
|
Period 3-DB Maintenance Phase
STARTED
|
0
|
0
|
98
|
48
|
|
Period 3-DB Maintenance Phase
COMPLETED
|
0
|
0
|
15
|
6
|
|
Period 3-DB Maintenance Phase
NOT COMPLETED
|
0
|
0
|
83
|
42
|
Reasons for withdrawal
| Measure |
Aripiprazole-Conversion Phase
Participants who had received oral aripiprazole 2 to 10 mg for 2 Weeks in combination with any other antipsychotic were in conversion phase.
|
Aripiprazole-Stabilization Phase
Participants who had converted to aripiprazole monotherapy period 1 (conversion phase) and had received aripiprazole monotherapy for schizophrenia at screening were in period 2, provided the prescribed aripiprazole dose did not exceed 30 mg (milligrams) per day for 2 Weeks.
|
Aripiprazole-Double Blind (DB) Maintenance
Participants who met stability criteria in period 2 (stabilization phase) received oral aripiprazole 10 to 30 mg/day for 52 Weeks in period 3 (double-blind maintenance treatment).
|
Aripiprazole-Placebo-DB Maintenance
Participants who met stability criteria in period 2 (stabilization phase) received placebo for 52 Weeks in period 3 (double-blind maintenance treatment).
|
|---|---|---|---|---|
|
Period 1 - Conversion Phase
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Period 1 - Conversion Phase
Sponsor Discontinued Trial
|
4
|
0
|
0
|
0
|
|
Period 1 - Conversion Phase
Met Withdrawal Criteria
|
1
|
0
|
0
|
0
|
|
Period 1 - Conversion Phase
Physician Decision
|
2
|
0
|
0
|
0
|
|
Period 1 - Conversion Phase
Withdrawal by Subject
|
7
|
0
|
0
|
0
|
|
Period 1 - Conversion Phase
Adverse Event Without Relapse
|
3
|
0
|
0
|
0
|
|
Period 2-Stabilization Phase
Sponsor Discontinued Trial
|
0
|
16
|
0
|
0
|
|
Period 2-Stabilization Phase
Met Withdrawal Criteria
|
0
|
7
|
0
|
0
|
|
Period 2-Stabilization Phase
Physician Decision
|
0
|
3
|
0
|
0
|
|
Period 2-Stabilization Phase
Withdrawal by Subject
|
0
|
5
|
0
|
0
|
|
Period 2-Stabilization Phase
Adverse Event Without Relapse
|
0
|
6
|
0
|
0
|
|
Period 3-DB Maintenance Phase
Sponsor Discontinued Trial
|
0
|
0
|
58
|
19
|
|
Period 3-DB Maintenance Phase
Physician Decision
|
0
|
0
|
1
|
0
|
|
Period 3-DB Maintenance Phase
Withdrawal by Subject
|
0
|
0
|
4
|
4
|
|
Period 3-DB Maintenance Phase
Adverse Event Without Relapse
|
0
|
0
|
1
|
1
|
|
Period 3-DB Maintenance Phase
Relapse With AE
|
0
|
0
|
19
|
18
|
Baseline Characteristics
Efficacy & Safety Study of Oral Aripiprazole in Adolescents With Schizophrenia
Baseline characteristics by cohort
| Measure |
Aripiprazole-Double Blind Maintenance
n=98 Participants
Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
|
Placebo-Double Blind Maintenance
n=48 Participants
Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Male
|
15.3 Years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
15.6 Years
STANDARD_DEVIATION 1.1 • n=7 Participants
|
15.4 Years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Age, Continuous
Female
|
15.4 Years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
15.3 Years
STANDARD_DEVIATION 1.0 • n=7 Participants
|
15.3 Years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 52/End of Phase 3 visit.Population: For the primary analysis, participants that belonged to the ITT (intent to treat) data set were included in the analysis. Participants who were lost to follow-up or who were still in the study at the end of Week 52 were considered as censored on their date of last efficacy evaluation. The ITT data set comprised participants randomized to period 3.
The primary efficacy variable was overall relapse rate from randomization, as assessed by Clinical Global Impression of Improvement (CGI-I) score ≥5, Positive and Negative Syndrome Scale (PANSS) scores for hostility or uncooperativeness ≥5, or ≥20% increase in PANSS Total Score. Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score \> 4 with an absolute increase of ≥ 2 on that specific item or absolute increase of ≥ 4 on the combined 4 PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content). OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Any suicidal behavior or answers of "yes" to Questions 4 or 5 on the suicidal ideation section of the C-SSRS OR 5) Violent or aggressive behavior resulting in clinically significant injury.
Outcome measures
| Measure |
Aripiprazole-Double Blind Maintenance
n=98 Participants
Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
|
Placebo-Double Blind Maintenance
n=48 Participants
Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
|
|---|---|---|
|
Overall Relapse Rate (in Percent) From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse.
|
19.39 relapse rate(percentage of participants)
|
37.50 relapse rate(percentage of participants)
|
SECONDARY outcome
Timeframe: Baseline to Week 52/End of Phase 3 visit.Population: The ITT data set comprised of all participants who were randomized to period 3.
Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score \> 4 with an absolute increase of ≥ 2 on that specific item or absolute increase of ≥ 4 on the combined 4 PANSS items. OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Any suicidal behavior or answers of "yes" to Questions 4 or 5 on the suicidal ideation section of the C-SSRS OR 5) Violent or aggressive behavior resulting in clinically significant injury.
Outcome measures
| Measure |
Aripiprazole-Double Blind Maintenance
n=98 Participants
Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
|
Placebo-Double Blind Maintenance
n=48 Participants
Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.
CGI-I + PANSS
|
16.33 percentage of participants
|
33.33 percentage of participants
|
|
Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.
CGI-I of 6 or 7
|
11.22 percentage of participants
|
25.00 percentage of participants
|
|
Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.
Hospitalization
|
1.02 percentage of participants
|
10.42 percentage of participants
|
|
Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.
Suicidal Behavior
|
1.02 percentage of participants
|
0.00 percentage of participants
|
|
Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.
Violent Behavior
|
4.08 percentage of participants
|
10.42 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52/End of Phase 3 visitPopulation: The ITT data set comprised of all participants were randomized to period 3.
Percentage of responders in each treatment group (i.e, response defined as meeting stability criteria). Participants stabilized on aripiprazole (trial drug) within the approved dose range of 10 to 30 mg/day and are tolerable based on clinical judgment.
Outcome measures
| Measure |
Aripiprazole-Double Blind Maintenance
n=98 Participants
Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
|
Placebo-Double Blind Maintenance
n=48 Participants
Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
|
|---|---|---|
|
Percentage of Responders in Each Treatment Group.
Last Visit (N= 98, 48)
|
77.6 percentage of participants
|
64.6 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 1 (Arirpiprazole N= 95, Placebo N= 45)
|
96.8 percentage of participants
|
97.8 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 2 (N= 91, 46)
|
92.3 percentage of participants
|
95.7 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 3 (N= 86, 45)
|
93.0 percentage of participants
|
86.7 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 4 (N= 91, 43)
|
93.4 percentage of participants
|
90.7 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 6 (N= 87, 41)
|
90.8 percentage of participants
|
92.7 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 8 (N= 82, 38)
|
97.6 percentage of participants
|
89.5 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 10 (N= 74, 32)
|
94.6 percentage of participants
|
93.8 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 12 (N= 71, 30)
|
94.4 percentage of participants
|
93.3 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 14 (N= 68, 26)
|
94.1 percentage of participants
|
92.3 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 16 (N= 65, 25)
|
96.9 percentage of participants
|
96.0 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 18 (N= 59, 23)
|
94.9 percentage of participants
|
91.3 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 20 (N= 57, 23)
|
94.7 percentage of participants
|
91.3 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 22 (N= 55, 21)
|
92.7 percentage of participants
|
95.2 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 24 (N= 51, 19)
|
98.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 26 (N= 48, 19)
|
97.9 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 28 (N= 42, 17)
|
97.6 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 30 (N= 40, 16)
|
95.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 32 (N= 39, 16)
|
94.9 percentage of participants
|
93.8 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 34 (N= 38, 14)
|
94.7 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 36 (N= 36, 15)
|
94.4 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 38 (N= 33, 12)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 40 (N= 29, 11)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 42 (N= 27, 11)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 44 (N= 21, 8)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 46 (N= 18, 8)
|
88.9 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 48 (N= 17, 8)
|
94.1 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 50 (N= 17, 6)
|
88.2 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Responders in Each Treatment Group.
Week 52 (N= 14, 7)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52/End of Phase 3 visit.Population: The ITT data set comprised of participants who were randomized to the double-blind treatment. For evaluation of remission, 48 of 98 aripiprazole participants and 19 of 48 placebo participants met the 6 month threshold for remission analysis. Of those, 21 of 48 aripiprazole participants and 8 of 19 placebo participants met criteria for remission.
Percentage of participants who had achieved remission, where remission was defined as a score of ≤ 3 on each of the following specific PANSS items, maintained for a period of 6 months: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/ posturing, blunted affect, social withdrawal, and lack of spontaneity.
Outcome measures
| Measure |
Aripiprazole-Double Blind Maintenance
n=48 Participants
Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
|
Placebo-Double Blind Maintenance
n=19 Participants
Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants Who Had Achieved Remission.
|
43.8 percentage of participants
|
42.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52/End of Phase 3 visitPopulation: The ITT data set comprised of all participants who were randomized to period 3.
Percentage of participants discontinued due to all reasons other than sponsor discontinued study were noted.
Outcome measures
| Measure |
Aripiprazole-Double Blind Maintenance
n=98 Participants
Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
|
Placebo-Double Blind Maintenance
n=48 Participants
Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants Who Discontinued Due to All Reasons Other Than Sponsor Discontinued Study.
|
25.51 percentage of participants
|
47.92 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 52/End of Phase 3 visit.Population: The ITT data set comprised of participants randomized to period 3. LOCF (last observation carried forward) method was used to impute missing data. Week 1 had only 95 and 45 participants analyzed.
The PANSS consisted of 3 subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale were positive subscale, negative subscale and general psychopathology subscale. The PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Outcome measures
| Measure |
Aripiprazole-Double Blind Maintenance
n=98 Participants
Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
|
Placebo-Double Blind Maintenance
n=48 Participants
Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
|
|---|---|---|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 1 (Aripiprazole N= 95, Placebo N= 45)
|
0.22 Units on a scale
Standard Deviation 5.62
|
-0.27 Units on a scale
Standard Deviation 4.66
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 2
|
0.09 Units on a scale
Standard Deviation 5.77
|
-0.58 Units on a scale
Standard Deviation 6.01
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 3
|
-0.36 Units on a scale
Standard Deviation 6.41
|
1.81 Units on a scale
Standard Deviation 9.66
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 4
|
-0.64 Units on a scale
Standard Deviation 6.90
|
1.56 Units on a scale
Standard Deviation 11.13
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 6
|
-1.20 Units on a scale
Standard Deviation 8.28
|
2.92 Units on a scale
Standard Deviation 13.39
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 8
|
-1.62 Units on a scale
Standard Deviation 9.20
|
3.71 Units on a scale
Standard Deviation 14.29
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 10
|
-1.20 Units on a scale
Standard Deviation 9.61
|
3.90 Units on a scale
Standard Deviation 14.80
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 12
|
-0.19 Units on a scale
Standard Deviation 10.57
|
4.52 Units on a scale
Standard Deviation 16.17
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 14
|
-0.18 Units on a scale
Standard Deviation 11.06
|
5.50 Units on a scale
Standard Deviation 17.21
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 16
|
-0.78 Units on a scale
Standard Deviation 11.72
|
5.56 Units on a scale
Standard Deviation 17.33
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 18
|
-0.68 Units on a scale
Standard Deviation 12.30
|
5.57 Units on a scale
Standard Deviation 17.24
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 20
|
-0.57 Units on a scale
Standard Deviation 12.46
|
6.06 Units on a scale
Standard Deviation 17.84
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 22
|
-0.31 Units on a scale
Standard Deviation 12.37
|
6.10 Units on a scale
Standard Deviation 18.98
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 24
|
-0.36 Units on a scale
Standard Deviation 12.36
|
5.92 Units on a scale
Standard Deviation 19.22
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 26
|
-0.88 Units on a scale
Standard Deviation 12.41
|
5.81 Units on a scale
Standard Deviation 19.65
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 28
|
-0.85 Units on a scale
Standard Deviation 12.52
|
5.65 Units on a scale
Standard Deviation 19.82
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 30
|
-0.96 Units on a scale
Standard Deviation 12.71
|
5.60 Units on a scale
Standard Deviation 19.96
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 32
|
-0.99 Units on a scale
Standard Deviation 12.74
|
6.21 Units on a scale
Standard Deviation 20.43
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 34
|
-1.12 Units on a scale
Standard Deviation 13.05
|
5.79 Units on a scale
Standard Deviation 19.85
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 36
|
-0.55 Units on a scale
Standard Deviation 13.04
|
5.40 Units on a scale
Standard Deviation 20.20
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 38
|
-0.84 Units on a scale
Standard Deviation 13.17
|
5.21 Units on a scale
Standard Deviation 20.27
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 40
|
-0.92 Units on a scale
Standard Deviation 13.21
|
5.10 Units on a scale
Standard Deviation 20.34
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 42
|
-1.14 Units on a scale
Standard Deviation 13.26
|
4.94 Units on a scale
Standard Deviation 20.36
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 44
|
-0.96 Units on a scale
Standard Deviation 13.32
|
4.88 Units on a scale
Standard Deviation 20.47
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 46
|
-1.02 Units on a scale
Standard Deviation 13.35
|
4.83 Units on a scale
Standard Deviation 20.54
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 48
|
-0.99 Units on a scale
Standard Deviation 13.34
|
4.67 Units on a scale
Standard Deviation 20.72
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 50
|
-1.19 Units on a scale
Standard Deviation 13.43
|
4.71 Units on a scale
Standard Deviation 20.66
|
|
Mean Change From Baseline to Endpoint in PANSS Total Score.
Week 52
|
-1.31 Units on a scale
Standard Deviation 13.47
|
4.79 Units on a scale
Standard Deviation 20.60
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 52/End of Phase 3 visit.Population: The ITT data set comprised of participants randomized to period 3. LOCF method was used to impute missing data. Week 1 participants analyzed were 94 and 45 and Week 2 to Week 52 participants analyzed were 97 and 48.
The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-s, the Investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices included: 0= not assessed; 1= normal, not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants.
Outcome measures
| Measure |
Aripiprazole-Double Blind Maintenance
n=98 Participants
Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
|
Placebo-Double Blind Maintenance
n=48 Participants
Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
|
|---|---|---|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 1 (Aripiprazole N= 94, Placebo N= 45)
|
0.01 Units on a scale
Standard Deviation 0.23
|
0.02 Units on a scale
Standard Deviation 0.34
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 2 (N= 97, 48)
|
0.00 Units on a scale
Standard Deviation 0.32
|
0.02 Units on a scale
Standard Deviation 0.44
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 3
|
0.01 Units on a scale
Standard Deviation 0.40
|
0.13 Units on a scale
Standard Deviation 0.64
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 4
|
0.03 Units on a scale
Standard Deviation 0.44
|
0.10 Units on a scale
Standard Deviation 0.69
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 6
|
0.04 Units on a scale
Standard Deviation 0.52
|
0.15 Units on a scale
Standard Deviation 0.77
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 8
|
0.04 Units on a scale
Standard Deviation 0.63
|
0.19 Units on a scale
Standard Deviation 0.79
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 10
|
0.02 Units on a scale
Standard Deviation 0.71
|
0.25 Units on a scale
Standard Deviation 0.81
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 12
|
0.05 Units on a scale
Standard Deviation 0.77
|
0.31 Units on a scale
Standard Deviation 0.85
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 14
|
0.03 Units on a scale
Standard Deviation 0.78
|
0.35 Units on a scale
Standard Deviation 1.04
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 16
|
0.02 Units on a scale
Standard Deviation 0.83
|
0.33 Units on a scale
Standard Deviation 1.06
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 18
|
0.04 Units on a scale
Standard Deviation 0.83
|
0.35 Units on a scale
Standard Deviation 1.06
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 20
|
0.05 Units on a scale
Standard Deviation 0.85
|
0.40 Units on a scale
Standard Deviation 1.12
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 22
|
0.08 Units on a scale
Standard Deviation 0.87
|
0.38 Units on a scale
Standard Deviation 1.14
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 24
|
0.06 Units on a scale
Standard Deviation 0.88
|
0.35 Units on a scale
Standard Deviation 1.18
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 26
|
0.05 Units on a scale
Standard Deviation 0.89
|
0.35 Units on a scale
Standard Deviation 1.18
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 28
|
0.05 Units on a scale
Standard Deviation 0.92
|
0.33 Units on a scale
Standard Deviation 1.19
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 30
|
0.04 Units on a scale
Standard Deviation 0.91
|
0.33 Units on a scale
Standard Deviation 1.19
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 32
|
0.04 Units on a scale
Standard Deviation 0.92
|
0.31 Units on a scale
Standard Deviation 1.21
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 34
|
0.05 Units on a scale
Standard Deviation 0.93
|
0.29 Units on a scale
Standard Deviation 1.22
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 36
|
0.07 Units on a scale
Standard Deviation 0.95
|
0.29 Units on a scale
Standard Deviation 1.22
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 38
|
0.07 Units on a scale
Standard Deviation 0.95
|
0.29 Units on a scale
Standard Deviation 1.22
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 40
|
0.07 Units on a scale
Standard Deviation 0.95
|
0.29 Units on a scale
Standard Deviation 1.22
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 42
|
0.06 Units on a scale
Standard Deviation 0.94
|
0.29 Units on a scale
Standard Deviation 1.22
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 44
|
0.08 Units on a scale
Standard Deviation 0.95
|
0.31 Units on a scale
Standard Deviation 1.21
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 46
|
0.07 Units on a scale
Standard Deviation 0.95
|
0.31 Units on a scale
Standard Deviation 1.21
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 48
|
0.06 Units on a scale
Standard Deviation 0.94
|
0.29 Units on a scale
Standard Deviation 1.22
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 50
|
0.05 Units on a scale
Standard Deviation 0.95
|
0.27 Units on a scale
Standard Deviation 1.25
|
|
Mean Change From Baseline to Endpoint in CGI-S Score.
Week 52
|
0.05 Units on a scale
Standard Deviation 0.95
|
0.29 Units on a scale
Standard Deviation 1.22
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 52/End of Phase 3 visit.Population: The ITT data set comprised of participants randomized to period 3. LOCF method was used to impute missing data. Week 1 participants analyzed were 94 and 45 and Week 2 to Week 52 participants analyzed were 97 and 48.
Baseline for the double-blind maintenance phase was defined as the last visit with available data in the stabilization phase, and the CGI-I scale was completed prior to or on the first dose date in the double-blind maintenance phase. Response choices included: 0 = not assessed; 1 = very much improved,;2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; and 7 = very much worse.
Outcome measures
| Measure |
Aripiprazole-Double Blind Maintenance
n=98 Participants
Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
|
Placebo-Double Blind Maintenance
n=48 Participants
Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
|
|---|---|---|
|
Mean CGI-I Score at Endpoint.
Baseline
|
2.40 Units on a scale
Standard Deviation 0.80
|
2.52 Units on a scale
Standard Deviation 0.82
|
|
Mean CGI-I Score at Endpoint.
Week 1 (Aripiprazole N= 94, Placebo N= 45)
|
3.49 Units on a scale
Standard Deviation 0.84
|
3.51 Units on a scale
Standard Deviation 0.84
|
|
Mean CGI-I Score at Endpoint.
Week 2 (N= 97, 48)
|
3.48 Units on a scale
Standard Deviation 0.88
|
3.52 Units on a scale
Standard Deviation 0.95
|
|
Mean CGI-I Score at Endpoint.
Week 3
|
3.47 Units on a scale
Standard Deviation 0.89
|
3.63 Units on a scale
Standard Deviation 1.06
|
|
Mean CGI-I Score at Endpoint.
Week 4
|
3.60 Units on a scale
Standard Deviation 0.92
|
3.60 Units on a scale
Standard Deviation 1.20
|
|
Mean CGI-I Score at Endpoint.
Week 6
|
3.53 Units on a scale
Standard Deviation 1.00
|
3.73 Units on a scale
Standard Deviation 1.30
|
|
Mean CGI-I Score at Endpoint.
Week 8
|
3.46 Units on a scale
Standard Deviation 1.09
|
3.83 Units on a scale
Standard Deviation 1.45
|
|
Mean CGI-I Score at Endpoint.
Week 10
|
3.38 Units on a scale
Standard Deviation 1.13
|
3.90 Units on a scale
Standard Deviation 1.49
|
|
Mean CGI-I Score at Endpoint.
Week 12
|
3.45 Units on a scale
Standard Deviation 1.19
|
3.96 Units on a scale
Standard Deviation 1.44
|
|
Mean CGI-I Score at Endpoint.
Week 14
|
3.44 Units on a scale
Standard Deviation 1.23
|
4.04 Units on a scale
Standard Deviation 1.56
|
|
Mean CGI-I Score at Endpoint.
Week 16
|
3.32 Units on a scale
Standard Deviation 1.25
|
4.00 Units on a scale
Standard Deviation 1.57
|
|
Mean CGI-I Score at Endpoint.
Week 18
|
3.35 Units on a scale
Standard Deviation 1.29
|
4.02 Units on a scale
Standard Deviation 1.58
|
|
Mean CGI-I Score at Endpoint.
Week 20
|
3.40 Units on a scale
Standard Deviation 1.30
|
4.08 Units on a scale
Standard Deviation 1.54
|
|
Mean CGI-I Score at Endpoint.
Week 22
|
3.43 Units on a scale
Standard Deviation 1.34
|
4.04 Units on a scale
Standard Deviation 1.60
|
|
Mean CGI-I Score at Endpoint.
Week 24
|
3.41 Units on a scale
Standard Deviation 1.31
|
4.06 Units on a scale
Standard Deviation 1.60
|
|
Mean CGI-I Score at Endpoint.
Week 26
|
3.41 Units on a scale
Standard Deviation 1.34
|
4.06 Units on a scale
Standard Deviation 1.60
|
|
Mean CGI-I Score at Endpoint.
Week 28
|
3.43 Units on a scale
Standard Deviation 1.34
|
4.02 Units on a scale
Standard Deviation 1.64
|
|
Mean CGI-I Score at Endpoint.
Week 30
|
3.44 Units on a scale
Standard Deviation 1.36
|
4.00 Units on a scale
Standard Deviation 1.66
|
|
Mean CGI-I Score at Endpoint.
Week 32
|
3.46 Units on a scale
Standard Deviation 1.37
|
3.98 Units on a scale
Standard Deviation 1.68
|
|
Mean CGI-I Score at Endpoint.
Week 34
|
3.47 Units on a scale
Standard Deviation 1.36
|
3.94 Units on a scale
Standard Deviation 1.71
|
|
Mean CGI-I Score at Endpoint.
Week 36
|
3.48 Units on a scale
Standard Deviation 1.39
|
3.94 Units on a scale
Standard Deviation 1.71
|
|
Mean CGI-I Score at Endpoint.
Week 38
|
3.45 Units on a scale
Standard Deviation 1.38
|
3.94 Units on a scale
Standard Deviation 1.71
|
|
Mean CGI-I Score at Endpoint.
Week 40
|
3.45 Units on a scale
Standard Deviation 1.38
|
3.92 Units on a scale
Standard Deviation 1.72
|
|
Mean CGI-I Score at Endpoint.
Week 42
|
3.45 Units on a scale
Standard Deviation 1.38
|
3.92 Units on a scale
Standard Deviation 1.72
|
|
Mean CGI-I Score at Endpoint.
Week 44
|
3.45 Units on a scale
Standard Deviation 1.38
|
3.94 Units on a scale
Standard Deviation 1.71
|
|
Mean CGI-I Score at Endpoint.
Week 46
|
3.46 Units on a scale
Standard Deviation 1.37
|
3.94 Units on a scale
Standard Deviation 1.71
|
|
Mean CGI-I Score at Endpoint.
Week 48
|
3.46 Units on a scale
Standard Deviation 1.38
|
3.92 Units on a scale
Standard Deviation 1.72
|
|
Mean CGI-I Score at Endpoint.
Week 50
|
3.43 Units on a scale
Standard Deviation 1.38
|
3.92 Units on a scale
Standard Deviation 1.72
|
|
Mean CGI-I Score at Endpoint.
Week 52
|
3.42 Units on a scale
Standard Deviation 1.39
|
3.92 Units on a scale
Standard Deviation 1.72
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 52/End of Phase 3 visit.Population: The ITT data set comprised of participants randomized to period 3. LOCF method was used to impute missing data. Week 1 participants analyzed were 94 and 45.
The PANSS consisted of 3 subscales were a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated (absence of symptoms) and a score of 7 indicated (extremely severe symptoms). The 7 positive symptom constructs were delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Outcome measures
| Measure |
Aripiprazole-Double Blind Maintenance
n=98 Participants
Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
|
Placebo-Double Blind Maintenance
n=48 Participants
Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
|
|---|---|---|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 46
|
0.21 Units on a scale
Standard Deviation 4.52
|
2.42 Units on a scale
Standard Deviation 6.69
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 1 (Aripiprazole N= 95, Placebo N= 45)
|
0.08 Units on a scale
Standard Deviation 1.84
|
0.07 Units on a scale
Standard Deviation 2.41
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 2
|
0.09 Units on a scale
Standard Deviation 2.05
|
-0.04 Units on a scale
Standard Deviation 2.87
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 3
|
0.01 Units on a scale
Standard Deviation 2.36
|
0.56 Units on a scale
Standard Deviation 3.34
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 4
|
-0.12 Units on a scale
Standard Deviation 2.65
|
0.58 Units on a scale
Standard Deviation 3.80
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 6
|
-0.20 Units on a scale
Standard Deviation 2.90
|
1.10 Units on a scale
Standard Deviation 4.85
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 8
|
-0.19 Units on a scale
Standard Deviation 3.23
|
1.56 Units on a scale
Standard Deviation 5.11
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 10
|
-0.16 Units on a scale
Standard Deviation 3.28
|
1.63 Units on a scale
Standard Deviation 5.45
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 12
|
0.23 Units on a scale
Standard Deviation 3.58
|
1.96 Units on a scale
Standard Deviation 5.78
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 14
|
0.28 Units on a scale
Standard Deviation 3.77
|
2.27 Units on a scale
Standard Deviation 6.03
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 16
|
0.32 Units on a scale
Standard Deviation 3.77
|
2.17 Units on a scale
Standard Deviation 6.05
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 18
|
0.24 Units on a scale
Standard Deviation 3.98
|
2.15 Units on a scale
Standard Deviation 6.14
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 20
|
0.18 Units on a scale
Standard Deviation 4.00
|
2.44 Units on a scale
Standard Deviation 6.32
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 22
|
0.39 Units on a scale
Standard Deviation 4.12
|
2.60 Units on a scale
Standard Deviation 6.44
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 24
|
0.38 Units on a scale
Standard Deviation 4.23
|
2.65 Units on a scale
Standard Deviation 6.36
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 26
|
0.22 Units on a scale
Standard Deviation 4.23
|
2.58 Units on a scale
Standard Deviation 6.45
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 28
|
0.17 Units on a scale
Standard Deviation 4.28
|
2.56 Units on a scale
Standard Deviation 6.51
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 30
|
0.24 Units on a scale
Standard Deviation 4.43
|
2.60 Units on a scale
Standard Deviation 6.59
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 32
|
0.22 Units on a scale
Standard Deviation 4.41
|
2.71 Units on a scale
Standard Deviation 6.64
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 34
|
0.18 Units on a scale
Standard Deviation 4.45
|
2.58 Units on a scale
Standard Deviation 6.54
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 36
|
0.29 Units on a scale
Standard Deviation 4.45
|
2.48 Units on a scale
Standard Deviation 6.60
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 38
|
0.22 Units on a scale
Standard Deviation 4.55
|
2.46 Units on a scale
Standard Deviation 6.63
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 40
|
0.27 Units on a scale
Standard Deviation 4.56
|
2.44 Units on a scale
Standard Deviation 6.69
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 42
|
0.24 Units on a scale
Standard Deviation 4.52
|
2.35 Units on a scale
Standard Deviation 6.73
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 44
|
0.27 Units on a scale
Standard Deviation 4.52
|
2.33 Units on a scale
Standard Deviation 6.76
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 48
|
0.30 Units on a scale
Standard Deviation 4.53
|
2.29 Units on a scale
Standard Deviation 6.77
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 50
|
0.20 Units on a scale
Standard Deviation 4.52
|
2.33 Units on a scale
Standard Deviation 6.75
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Week 52
|
0.16 Units on a scale
Standard Deviation 4.55
|
2.31 Units on a scale
Standard Deviation 6.77
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 52/End of Phase 3 visit.Population: The ITT data set comprised of participants randomized to period 3. LOCF method was used to impute missing data. Week 1 participants analyzed were 94 and 45.
The PANSS consisted of 3 subscales were a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated (absence of symptoms) and a score of 7 indicated (extremely severe symptoms). The 7 negative symptom constructs were blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. The PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Outcome measures
| Measure |
Aripiprazole-Double Blind Maintenance
n=98 Participants
Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
|
Placebo-Double Blind Maintenance
n=48 Participants
Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
|
|---|---|---|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 2
|
-0.07 Units on a scale
Standard Deviation 1.68
|
-0.23 Units on a scale
Standard Deviation 2.35
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 3
|
-0.39 Units on a scale
Standard Deviation 1.89
|
0.48 Units on a scale
Standard Deviation 3.17
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 4
|
-0.27 Units on a scale
Standard Deviation 2.12
|
0.44 Units on a scale
Standard Deviation 3.41
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 6
|
-0.42 Units on a scale
Standard Deviation 2.37
|
0.90 Units on a scale
Standard Deviation 3.57
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 8
|
-0.41 Units on a scale
Standard Deviation 2.37
|
0.77 Units on a scale
Standard Deviation 3.76
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 10
|
-0.33 Units on a scale
Standard Deviation 2.47
|
0.71 Units on a scale
Standard Deviation 3.82
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 12
|
-0.38 Units on a scale
Standard Deviation 2.91
|
0.79 Units on a scale
Standard Deviation 4.47
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 14
|
-0.41 Units on a scale
Standard Deviation 3.13
|
1.15 Units on a scale
Standard Deviation 4.63
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 16
|
-0.51 Units on a scale
Standard Deviation 3.31
|
1.19 Units on a scale
Standard Deviation 4.77
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 18
|
-0.47 Units on a scale
Standard Deviation 3.45
|
1.19 Units on a scale
Standard Deviation 4.75
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 20
|
-0.47 Units on a scale
Standard Deviation 3.54
|
1.10 Units on a scale
Standard Deviation 4.93
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 22
|
-0.43 Units on a scale
Standard Deviation 3.55
|
1.06 Units on a scale
Standard Deviation 5.26
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 24
|
-0.42 Units on a scale
Standard Deviation 3.54
|
0.79 Units on a scale
Standard Deviation 5.41
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 26
|
-0.54 Units on a scale
Standard Deviation 3.60
|
0.81 Units on a scale
Standard Deviation 5.43
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 28
|
-0.51 Units on a scale
Standard Deviation 3.63
|
0.83 Units on a scale
Standard Deviation 5.43
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 30
|
-0.56 Units on a scale
Standard Deviation 3.57
|
0.67 Units on a scale
Standard Deviation 5.55
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 32
|
-0.52 Units on a scale
Standard Deviation 3.60
|
0.98 Units on a scale
Standard Deviation 5.89
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 34
|
-0.64 Units on a scale
Standard Deviation 3.68
|
0.56 Units on a scale
Standard Deviation 5.61
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 36
|
-0.47 Units on a scale
Standard Deviation 3.71
|
0.65 Units on a scale
Standard Deviation 5.69
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 38
|
-0.62 Units on a scale
Standard Deviation 3.70
|
0.54 Units on a scale
Standard Deviation 5.84
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 1 (Aripiprazole N= 95, Placebo N= 45)
|
0.03 Units on a scale
Standard Deviation 1.57
|
-0.09 Units on a scale
Standard Deviation 1.40
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 40
|
-0.64 Units on a scale
Standard Deviation 3.78
|
0.54 Units on a scale
Standard Deviation 5.78
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 42
|
-0.77 Units on a scale
Standard Deviation 3.79
|
0.42 Units on a scale
Standard Deviation 5.75
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 44
|
-0.72 Units on a scale
Standard Deviation 3.87
|
0.46 Units on a scale
Standard Deviation 5.76
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 46
|
-0.68 Units on a scale
Standard Deviation 3.84
|
0.35 Units on a scale
Standard Deviation 5.83
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 48
|
-0.73 Units on a scale
Standard Deviation 3.83
|
0.33 Units on a scale
Standard Deviation 5.88
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 50
|
-0.80 Units on a scale
Standard Deviation 3.84
|
0.29 Units on a scale
Standard Deviation 5.96
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Week 52
|
-0.78 Units on a scale
Standard Deviation 3.81
|
0.40 Units on a scale
Standard Deviation 5.87
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 52/End of Phase 3 visit.Population: The ITT data set comprised of participants randomized to period 3. LOCF method was used to impute missing data. Week 1 participants analyzed were 95 and 45.
The CGAS was developed by Schaffer and colleagues to provide a global measure of severity of disturbance in children and adolescents. The CGAS is a rating scale for evaluating the overall functioning of a participant during a specified time period on a continuum from psychological or psychiatric sickness to health. The CGAS is a valid and reliable tool for rating a child's general level of functioning on a health-illness continuum. CGAS score (range 1-100) was a single item score for rating a child's general level of functioning on a health-illness continuum, with higher scores represented better functioning.
Outcome measures
| Measure |
Aripiprazole-Double Blind Maintenance
n=98 Participants
Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
|
Placebo-Double Blind Maintenance
n=48 Participants
Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
|
|---|---|---|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 20
|
1.28 Units on a scale
Standard Deviation 9.88
|
-4.06 Units on a scale
Standard Deviation 14.84
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 22
|
1.17 Units on a scale
Standard Deviation 10.15
|
-3.77 Units on a scale
Standard Deviation 15.05
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 24
|
1.33 Units on a scale
Standard Deviation 10.33
|
-3.67 Units on a scale
Standard Deviation 15.20
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 1 (Aripiprazole N= 95, Placebo N= 45)
|
0.00 Units on a scale
Standard Deviation 2.74
|
-0.09 Units on a scale
Standard Deviation 2.02
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 2
|
-0.10 Units on a scale
Standard Deviation 3.90
|
-0.31 Units on a scale
Standard Deviation 4.03
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 3
|
0.35 Units on a scale
Standard Deviation 4.36
|
-1.04 Units on a scale
Standard Deviation 7.21
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 4
|
0.29 Units on a scale
Standard Deviation 5.22
|
-1.23 Units on a scale
Standard Deviation 7.78
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 6
|
0.40 Units on a scale
Standard Deviation 6.01
|
-2.08 Units on a scale
Standard Deviation 9.14
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 8
|
0.98 Units on a scale
Standard Deviation 6.90
|
-2.40 Units on a scale
Standard Deviation 9.93
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 10
|
1.11 Units on a scale
Standard Deviation 7.47
|
-2.31 Units on a scale
Standard Deviation 11.63
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 12
|
1.08 Units on a scale
Standard Deviation 8.21
|
-2.85 Units on a scale
Standard Deviation 11.40
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 14
|
1.06 Units on a scale
Standard Deviation 8.49
|
-3.52 Units on a scale
Standard Deviation 12.40
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 16
|
1.57 Units on a scale
Standard Deviation 8.69
|
-2.69 Units on a scale
Standard Deviation 12.96
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 18
|
1.55 Units on a scale
Standard Deviation 9.41
|
-2.90 Units on a scale
Standard Deviation 13.07
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 26
|
1.61 Units on a scale
Standard Deviation 10.37
|
-3.69 Units on a scale
Standard Deviation 15.29
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 28
|
1.73 Units on a scale
Standard Deviation 10.73
|
-3.75 Units on a scale
Standard Deviation 15.26
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 30
|
1.92 Units on a scale
Standard Deviation 10.89
|
-3.44 Units on a scale
Standard Deviation 15.45
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 32
|
1.86 Units on a scale
Standard Deviation 11.03
|
-3.33 Units on a scale
Standard Deviation 15.47
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 34
|
2.05 Units on a scale
Standard Deviation 11.19
|
-3.00 Units on a scale
Standard Deviation 15.85
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 36
|
1.87 Units on a scale
Standard Deviation 11.41
|
-3.10 Units on a scale
Standard Deviation 15.70
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 38
|
2.00 Units on a scale
Standard Deviation 11.59
|
-2.85 Units on a scale
Standard Deviation 15.95
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 40
|
1.90 Units on a scale
Standard Deviation 11.68
|
-2.85 Units on a scale
Standard Deviation 15.99
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 42
|
1.90 Units on a scale
Standard Deviation 11.74
|
-2.69 Units on a scale
Standard Deviation 16.17
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 44
|
1.83 Units on a scale
Standard Deviation 11.86
|
-2.67 Units on a scale
Standard Deviation 16.18
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 46
|
2.13 Units on a scale
Standard Deviation 11.74
|
-2.67 Units on a scale
Standard Deviation 16.17
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 48
|
2.17 Units on a scale
Standard Deviation 11.79
|
-2.40 Units on a scale
Standard Deviation 16.42
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 50
|
2.29 Units on a scale
Standard Deviation 11.74
|
-2.31 Units on a scale
Standard Deviation 16.51
|
|
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Week 52
|
2.35 Units on a scale
Standard Deviation 11.85
|
-2.25 Units on a scale
Standard Deviation 16.58
|
Adverse Events
Aripiprazole-Conversion Phase
Serious events: 0 serious events
Other events: 52 other events
Deaths: 0 deaths
Arpiprazole-Stabilization Phase
Serious events: 4 serious events
Other events: 56 other events
Deaths: 0 deaths
Aripiprazole-Double Blind Maintenance Treatment
Serious events: 3 serious events
Other events: 41 other events
Deaths: 0 deaths
Placebo-Double Blind Maintenance Treatment
Serious events: 6 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aripiprazole-Conversion Phase
n=186 participants at risk
Participants had received oral aripiprazole 2 to 10 mg for 2 Weeks in combination with any other antipsychotic were in conversion phase.
|
Arpiprazole-Stabilization Phase
n=183 participants at risk
Participants who had converted to aripiprazole monotherapy period 1 (conversion phase) and had received aripiprazole monotherapy for schizophrenia at screening were in period 2, provided the prescribed aripiprazole dose did not exceed 30 mg (milligrams) per day for 2 Weeks.
|
Aripiprazole-Double Blind Maintenance Treatment
n=98 participants at risk
Participants who met stability criteria in period 2 (stabilization phase) had received oral aripiprazole 10 to 30 mg/day for 52 Weeks in period 3 (double-blind maintenance treatment).
|
Placebo-Double Blind Maintenance Treatment
n=48 participants at risk
Participants who met stability criteria in period 2 (stabilization phase) had received placebo for 52 Weeks in period 3 (double-blind maintenance treatment).
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/186 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
0.55%
1/183 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
0.00%
0/98 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
0.00%
0/48 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/186 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
0.55%
1/183 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
2.0%
2/98 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
2.1%
1/48 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/186 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
1.1%
2/183 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
1.0%
1/98 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
10.4%
5/48 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
Other adverse events
| Measure |
Aripiprazole-Conversion Phase
n=186 participants at risk
Participants had received oral aripiprazole 2 to 10 mg for 2 Weeks in combination with any other antipsychotic were in conversion phase.
|
Arpiprazole-Stabilization Phase
n=183 participants at risk
Participants who had converted to aripiprazole monotherapy period 1 (conversion phase) and had received aripiprazole monotherapy for schizophrenia at screening were in period 2, provided the prescribed aripiprazole dose did not exceed 30 mg (milligrams) per day for 2 Weeks.
|
Aripiprazole-Double Blind Maintenance Treatment
n=98 participants at risk
Participants who met stability criteria in period 2 (stabilization phase) had received oral aripiprazole 10 to 30 mg/day for 52 Weeks in period 3 (double-blind maintenance treatment).
|
Placebo-Double Blind Maintenance Treatment
n=48 participants at risk
Participants who met stability criteria in period 2 (stabilization phase) had received placebo for 52 Weeks in period 3 (double-blind maintenance treatment).
|
|---|---|---|---|---|
|
Nervous system disorders
Akathisia
|
5.9%
11/186 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
7.7%
14/183 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
3.1%
3/98 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
6.2%
3/48 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
|
Nervous system disorders
Headache
|
6.5%
12/186 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
7.1%
13/183 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
6.1%
6/98 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
8.3%
4/48 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
|
Psychiatric disorders
Insomnia
|
8.6%
16/186 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
7.7%
14/183 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
5.1%
5/98 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
18.8%
9/48 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/186 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
0.00%
0/183 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
7.1%
7/98 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
2.1%
1/48 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/186 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
0.00%
0/183 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
1.0%
1/98 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
6.2%
3/48 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/186 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
0.00%
0/183 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
7.1%
7/98 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
8.3%
4/48 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/186 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
0.00%
0/183 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
9.2%
9/98 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
16.7%
8/48 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
|
Nervous system disorders
Somnolence
|
10.2%
19/186 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
6.6%
12/183 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
0.00%
0/98 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
0.00%
0/48 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
|
Nervous system disorders
Tremor
|
0.00%
0/186 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
7.1%
13/183 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
4.1%
4/98 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
8.3%
4/48 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
|
Investigations
Weight increased
|
0.00%
0/186 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
7.1%
13/183 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
8.2%
8/98 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
10.4%
5/48 • AEs were recorded from the time the ICF was signed (with 4-Week Post-Trial Follow-up).
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
|
Additional Information
Global Medical Affairs
Otsuka Pharmaceutical Development and Commercialization, Inc.
Phone: 800 562-3974
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place