Trial Outcomes & Findings for Aripiprazole in Children and Adolescents With Bipolar I Disorder (NCT NCT00110461)
NCT ID: NCT00110461
Last Updated: 2012-05-21
Results Overview
Change from Baseline to Week 4 in Y-MRS total score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through the continuation phase.) The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).
COMPLETED
PHASE3
296 participants
Baseline and Week 4
2012-05-21
Participant Flow
Participants were recruited from 59 centers in the United States between March 2005 and February 2007. A total of 413 subjects were screened for enrollment, with 296 subjects assigned to double-blind treatment.
Participants were screened over a 28-day period.
Participant milestones
| Measure |
Aripiprazole 10 mg/Day
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
30-Week, Double-blind Treatment Phase
STARTED
|
98
|
99
|
99
|
|
30-Week, Double-blind Treatment Phase
COMPLETED
|
34
|
22
|
12
|
|
30-Week, Double-blind Treatment Phase
NOT COMPLETED
|
64
|
77
|
87
|
|
Acute Phase
STARTED
|
98
|
99
|
99
|
|
Acute Phase
COMPLETED
|
84
|
77
|
76
|
|
Acute Phase
NOT COMPLETED
|
14
|
22
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aripiprazole in Children and Adolescents With Bipolar I Disorder
Baseline characteristics by cohort
| Measure |
Aripiprazole 10 mg/Day
n=98 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=99 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=99 Participants
Participants were given a single pill administered once daily.
|
Total
n=296 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
13.70 years
STANDARD_DEVIATION 2.17 • n=5 Participants
|
13.31 years
STANDARD_DEVIATION 2.32 • n=7 Participants
|
13.28 years
STANDARD_DEVIATION 2.12 • n=5 Participants
|
13.43 years
STANDARD_DEVIATION 2.21 • n=4 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
137 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
159 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
92 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
265 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
193 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Height
|
161.05 centimeters (cm)
STANDARD_DEVIATION 12.45 • n=5 Participants
|
158.37 centimeters (cm)
STANDARD_DEVIATION 12.21 • n=7 Participants
|
158.69 centimeters (cm)
STANDARD_DEVIATION 11.63 • n=5 Participants
|
159.36 centimeters (cm)
STANDARD_DEVIATION 12.12 • n=4 Participants
|
|
Weight
|
63.76 kilograms (kg)
STANDARD_DEVIATION 20.11 • n=5 Participants
|
60.49 kilograms (kg)
STANDARD_DEVIATION 21.50 • n=7 Participants
|
60.48 kilograms (kg)
STANDARD_DEVIATION 17.31 • n=5 Participants
|
61.57 kilograms (kg)
STANDARD_DEVIATION 19.71 • n=4 Participants
|
|
Body Mass Index (BMI)
|
24.15 kg/m^2
STANDARD_DEVIATION 5.37 • n=5 Participants
|
23.66 kg/m^2
STANDARD_DEVIATION 6.70 • n=7 Participants
|
23.68 kg/m^2
STANDARD_DEVIATION 4.98 • n=5 Participants
|
23.83 kg/m^2
STANDARD_DEVIATION 5.72 • n=4 Participants
|
|
Young Mania Rating Scale Score (Y-MRS)
|
29.8 points
STANDARD_DEVIATION 6.5 • n=5 Participants
|
29.5 points
STANDARD_DEVIATION 6.3 • n=7 Participants
|
30.7 points
STANDARD_DEVIATION 6.8 • n=5 Participants
|
30.0 points
STANDARD_DEVIATION 6.5 • n=4 Participants
|
|
Children's Depression Rating Scale - Revised (CDRS-R) Suicidal Ideation Score
|
1.1 points
STANDARD_DEVIATION 0.4 • n=5 Participants
|
1.1 points
STANDARD_DEVIATION 0.5 • n=7 Participants
|
1.2 points
STANDARD_DEVIATION 0.5 • n=5 Participants
|
1.2 points
STANDARD_DEVIATION 0.5 • n=4 Participants
|
|
Treatment given for previous episodes
Yes
|
57 participants
n=5 Participants
|
50 participants
n=7 Participants
|
63 participants
n=5 Participants
|
170 participants
n=4 Participants
|
|
Treatment given for previous episodes
No
|
41 participants
n=5 Participants
|
49 participants
n=7 Participants
|
36 participants
n=5 Participants
|
126 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: Since the primary efficacy endpoint is change from baseline in Y-MRS total score, only randomized subjects who had both baseline and at least one post-baseline were included in the primary efficacy analysis. Therefore, number of randomized subjects be different number subjects included in the efficacy analysis.
Change from Baseline to Week 4 in Y-MRS total score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through the continuation phase.) The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=96 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=99 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=92 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4
|
-14.04 points
Standard Deviation 9.33 • Interval -8.49 to -3.5
|
-16.16 points
Standard Deviation 9.18 • Interval -10.7 to -5.77
|
-8.67 points
Standard Deviation 9.17
|
SECONDARY outcome
Timeframe: Baseline and Week 30Population: Since the endpoint is change from baseline in Y-MRS total score, only randomized subjects who had both baseline and at least one post-baseline were included in the primary efficacy analysis. Therefore, number of randomized subjects could be different number subjects included in the efficacy analysis.
Change from baseline to Week 30 in Y-MRS total score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=96 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=99 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=94 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 30
|
-13.91 points
Standard Deviation 10.83
|
-14.6 points
Standard Deviation 10.35
|
-8.69 points
Standard Deviation 9.88
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.
Change from baseline to Week 4 in CGAS total score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) The CGAS is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome).
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=96 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=99 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=92 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change in Children's Global Assessment Scale (CGAS) Total Score at Week 4
|
14.97 points
Standard Deviation 14.94
|
16.96 points
Standard Deviation 13.4
|
6.21 points
Standard Deviation 9.15
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.
Change from baseline to Week 4 in CGI-BP mania score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe).
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=96 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=99 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=92 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4
|
-1.6 points
Standard Deviation 1.3
|
-2.02 points
Standard Deviation 1.29
|
-0.89 points
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.
Change from baseline to Week 4 in CDRS-R score, using last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) The CDRS-R is used to diagnose depression and monitor treatment response. The interviewer rates 17 symptom areas (including those that sever as DSM-IV criteria for diagnosis of depression), among them suicidal ideation. Minimum score on the scale is 17 (better outcome). Maximum score on the scale is 113 (worse outcome or more severe symptoms).
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=91 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=94 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=85 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 4
|
-7.65 points
Standard Deviation 11.05
|
-5.97 points
Standard Deviation 10.88
|
-4.66 points
Standard Deviation 9.1
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.
Change from baseline to Week 4 in GBI Total Parent/Guardian Version Mania score, using LOCF. Assessments performed baseline and weekly through acute phase (Week 4). (Also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) GBI is self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=96 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=96 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=91 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 4
|
-9.66 points
Standard Deviation 9.14
|
-9.1 points
Standard Deviation 7.91
|
-4.63 points
Standard Deviation 8.97
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.
Change from baseline to Week 4 in ADHD-RS-IV Total score, using last observation carried forward. Assessments performed at baseline and weekly through acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) ADHD-RS-IV is an instrument for diagnosing ADHD in children/adolescents and for assessing treatment response. The scale contains 18 items linked directly to DSM-IV diagnostic criteria for ADHD. Parent questionnaire on home behaviors (Eng.) used in this study. Minimum score of 0 is a better outcome, maximum score of 54 is a worse outcome.
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=95 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=97 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=90 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 4
|
-12.03 points
Standard Deviation 13.09
|
-11.61 points
Standard Deviation 14.06
|
-4.57 points
Standard Deviation 9.88
|
SECONDARY outcome
Timeframe: Baseline and Week 30Population: Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.
Change from baseline to Week 30 in CGAS total score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. The CGAS is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome).
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=96 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=99 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=94 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change in Children's Global Assessment (CGAS) Total Score at Week 30
|
15.81 points
Standard Deviation 18.81
|
16.28 points
Standard Deviation 14.73
|
7.45 points
Standard Deviation 11.59
|
SECONDARY outcome
Timeframe: Baseline and Week 30Population: Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.
Change from baseline to Week 30 in CGI-BP mania score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe).
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=96 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=99 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=94 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30
|
-1.63 points
Standard Deviation 1.43
|
-1.93 points
Standard Deviation 1.4
|
-1.03 points
Standard Deviation 1.32
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.
Change from baseline to Week 4 in CGI-BP severity depression score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4. (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe).
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=96 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=99 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=92 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4
|
-0.86 points
Standard Deviation 1.37
|
-0.9 points
Standard Deviation 1.32
|
-0.57 points
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: Baseline and Week 30Population: Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.
Change from baseline to Week 30 in CGI-BP severity depression score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe).
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=96 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=99 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=94 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30
|
-0.71 points
Standard Deviation 1.44
|
-0.94 points
Standard Deviation 1.38
|
-0.47 points
Standard Deviation 1.45
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.
Change from baseline to Week 4 in CGI-BP severity overall illness score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe).
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=96 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=99 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=92 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4
|
-1.6 points
Standard Deviation 1.33
|
-1.91 points
Standard Deviation 1.21
|
-0.84 points
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: Baseline and Week 30Population: Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.
Change from baseline to Week 30 in CGI-BP severity overall illness score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe).
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=96 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=99 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=94 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30
|
-1.59 points
Standard Deviation 1.45
|
-1.75 points
Standard Deviation 1.34
|
-0.91 points
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: Baseline and Week 30Population: Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.
Change from baseline to Week 30 in CDRS-R score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. The CDRS-R is used to diagnose depression and monitor treatment response. The interviewer rates 17 symptom areas (including those that sever as DSM-IV criteria for diagnosis of depression), among them suicidal ideation. Minimum score on the scale is 17 (better outcome). Maximum score on the scale is 113 (worse outcome or more severe symptoms).
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=91 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=94 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=86 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 30
|
-6.47 points
Standard Deviation 11.74
|
-4.39 points
Standard Deviation 10.61
|
-3.81 points
Standard Deviation 10.91
|
SECONDARY outcome
Timeframe: Baseline and Week 30Population: Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.
Change from baseline to Week 30 in GBI Total Parent/Guardian Version Mania score, using LOCF. Assessments performed at baseline and weekly through acute phase(Week 4) and Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=95 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=96 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=93 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 30
|
-8.76 points
Standard Deviation 9.12
|
-8.48 points
Standard Deviation 8.44
|
-5 points
Standard Deviation 9.33
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.
Change from baseline to Week 4 in GBI Total Subject Version Mania score, using the LOCF. Assessments performed at baseline and weekly through acute phase (Week 4). (Also performed Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=96 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=96 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=91 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 4
|
-6.51 points
Standard Deviation 7.49
|
-6.52 points
Standard Deviation 7.49
|
-4.57 points
Standard Deviation 7.21
|
SECONDARY outcome
Timeframe: Baseline and Week 30Population: Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.
Change from baseline to Week 30 in GBI Total Subject Version Mania score, using LOCF. Assessments performed at baseline and weekly through acute phase (Week 4) and Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score of 0=better outcome, maximum score of 60=worse outcome.
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=96 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=96 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=93 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 30
|
-6.82 points
Standard Deviation 7.86
|
-7.84 points
Standard Deviation 7.7
|
-5.23 points
Standard Deviation 7.68
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.
Change from baseline to Week 4 in GBI Total Parent/Guardian Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on 4-point Likert scale from 0 (never/hardly ever) to 3 (often/almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=95 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=96 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=91 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 4
|
-6.12 points
Standard Deviation 8.78
|
-3.71 points
Standard Deviation 8.62
|
-3.92 points
Standard Deviation 8.82
|
SECONDARY outcome
Timeframe: Baseline and Week 30Population: Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.
Change from Baseline to Week 30 in GBI Total Parent/Guardian Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by parent/guardian. Symptoms rated on 4-point Likert scale from 0 (never/hardly ever) to 3 (often/almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=96 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=96 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=91 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 30
|
-5.17 points
Standard Deviation 9.13
|
-3.71 points
Standard Deviation 9
|
-3.03 points
Standard Deviation 9.27
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.
Change from Baseline to Week 4 in GBI Total Subject Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by subject. Symptoms wrated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=96 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=96 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=91 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 4
|
0 points
Standard Deviation 6.87
|
-3.24 points
Standard Deviation 6.96
|
-3.11 points
Standard Deviation 7.73
|
SECONDARY outcome
Timeframe: Baseline and Week 30Population: Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.
Change from baseline to Week 30 in GBI Total Subject Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=96 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=96 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=93 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 30
|
-4.45 points
Standard Deviation 7.62
|
-4.38 points
Standard Deviation 8.09
|
-2.7 points
Standard Deviation 8.44
|
SECONDARY outcome
Timeframe: Baseline and Week 30Population: Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.
Change from baseline to Week 30 in ADHD-RS-IV Total score, using the LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. The ADHD-RS-IV is an instrument both for diagnosing ADHD in children and adolescents and for assessing treatment response. The scale contains 18 items and is linked directly to DSM-IV diagnostic criteria for ADHD. The parent questionnaire on home behaviors (English) was used in this study. Minimum score of 0 = better outcome, maximum score of 54 = worse outcome.
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=95 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=97 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=91 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 30
|
-11.04 points
Standard Deviation 19.32
|
-9.76 points
Standard Deviation 13.44
|
-5.58 points
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Since the primary efficacy endpoint is change from baseline in Y-MRS total score, only randomized subjects who had both baseline and at least one post-baseline were included in the primary efficacy analysis. Therefore, number of randomized subjects could be different number subjects included in the efficacy analysis.
Percentage of Subjects with a 50% or higher reduction from baseline in Young Mania Rating Scale (Y-MRS) total score at Week 4. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=96 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=99 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=92 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Subject Response to Treatment at Week 4
|
44.79 percentage of participants
|
63.64 percentage of participants
|
26.09 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 30Population: Since the primary efficacy endpoint is change from baseline in Y-MRS total score, only randomized subjects who had both baseline and at least one post-baseline were included in the primary efficacy analysis. Therefore, number of randomized subjects could be different number subjects included in the efficacy analysis.
Percentage of Subjects with a 50% or higher reduction from baseline in Y-MRS total score at Week 30. Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=96 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=99 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=94 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Subject Response to Treatment at Week 30
|
50.00 percentage of participants
|
55.56 percentage of participants
|
26.60 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.
Change from previous phase to Week 4 in CGI-BP mania score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse).
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=96 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=99 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=92 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4
|
2.4 points
Standard Deviation 1.04
|
2.32 points
Standard Deviation 1.25
|
3.37 points
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Baseline and Week 30Population: Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.
Change from previous phase to Week 30 in CGI-BP mania score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse).
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=96 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=99 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=94 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30
|
2.61 points
Standard Deviation 1.43
|
2.45 points
Standard Deviation 1.39
|
3.26 points
Standard Deviation 1.35
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.
Change from previous phase to Week 4 in CGI-BP severity depression score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse).
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=96 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=99 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=92 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4
|
2.96 points
Standard Deviation 1.27
|
3.06 points
Standard Deviation 1.26
|
3.57 points
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: Baseline and Week 30Population: Since the endpoint is change from previous week, only randomized subjects who had both previous week and at least next week were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.
Change from previous phase to Week 30 in CGI-BP severity depression score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse).
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=96 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=99 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=94 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30
|
3.3 points
Standard Deviation 1.33
|
3.06 points
Standard Deviation 1.14
|
3.56 points
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.
Change from previous phase to Week 4 in CGI-BP severity overall illness score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse).
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=96 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=99 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=92 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4
|
2.48 points
Standard Deviation 1.09
|
2.41 points
Standard Deviation 1.2
|
3.47 points
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: Baseline and Week 30Population: Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.
Change from previous phase to Week 30 in CGI-BP severity overall illness score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse).
Outcome measures
| Measure |
Aripiprazole 10 mg/Day
n=96 Participants
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=99 Participants
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=94 Participants
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30
|
2.75 points
Standard Deviation 1.49
|
2.6 points
Standard Deviation 1.38
|
3.38 points
Standard Deviation 1.38
|
Adverse Events
Aripiprazole 10 mg/Day
Aripiprazole 30 mg/Day
Placebo
Serious adverse events
| Measure |
Aripiprazole 10 mg/Day
n=98 participants at risk
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=99 participants at risk
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=97 participants at risk
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
General disorders
Fatigue
|
1.0%
1/98
|
0.00%
0/99
|
0.00%
0/97
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
1.0%
1/98
|
0.00%
0/99
|
0.00%
0/97
|
|
Nervous system disorders
Grand mal convulsion
|
1.0%
1/98
|
0.00%
0/99
|
0.00%
0/97
|
|
Psychiatric disorders
Agression
|
2.0%
2/98
|
0.00%
0/99
|
0.00%
0/97
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/98
|
5.1%
5/99
|
4.1%
4/97
|
|
Psychiatric disorders
Bipolar I disorder
|
0.00%
0/98
|
2.0%
2/99
|
1.0%
1/97
|
|
Psychiatric disorders
Libido increased
|
0.00%
0/98
|
1.0%
1/99
|
0.00%
0/97
|
|
Psychiatric disorders
Mania
|
0.00%
0/98
|
0.00%
0/99
|
1.0%
1/97
|
|
Psychiatric disorders
Oppositional defiant disorder
|
1.0%
1/98
|
0.00%
0/99
|
0.00%
0/97
|
|
Psychiatric disorders
Suicidal ideation
|
1.0%
1/98
|
0.00%
0/99
|
0.00%
0/97
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
1.0%
1/98
|
0.00%
0/99
|
0.00%
0/97
|
Other adverse events
| Measure |
Aripiprazole 10 mg/Day
n=98 participants at risk
Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
|
Aripiprazole 30 mg/Day
n=99 participants at risk
Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
|
Placebo
n=97 participants at risk
Participants were given a single pill administered once daily.
|
|---|---|---|---|
|
Eye disorders
Vision blurred
|
10.2%
10/98
|
8.1%
8/99
|
1.0%
1/97
|
|
Gastrointestinal disorders
Abdominal pain
|
9.2%
9/98
|
5.1%
5/99
|
3.1%
3/97
|
|
Gastrointestinal disorders
Diarrhea
|
4.1%
4/98
|
5.1%
5/99
|
0.00%
0/97
|
|
Gastrointestinal disorders
Nausea
|
13.3%
13/98
|
14.1%
14/99
|
5.2%
5/97
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
3.1%
3/98
|
8.1%
8/99
|
0.00%
0/97
|
|
Gastrointestinal disorders
Stomach discomfort
|
2.0%
2/98
|
6.1%
6/99
|
2.1%
2/97
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
13/98
|
8.1%
8/99
|
9.3%
9/97
|
|
General disorders
Fatigue
|
18.4%
18/98
|
12.1%
12/99
|
4.1%
4/97
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
7/98
|
3.0%
3/99
|
3.1%
3/97
|
|
Infections and infestations
Upper respiratory tract infection
|
8.2%
8/98
|
6.1%
6/99
|
3.1%
3/97
|
|
Investigations
Weight increased
|
8.2%
8/98
|
5.1%
5/99
|
3.1%
3/97
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.1%
7/98
|
4.0%
4/99
|
3.1%
3/97
|
|
Metabolism and nutrition disorders
Increased appetite
|
8.2%
8/98
|
8.1%
8/99
|
3.1%
3/97
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
5/98
|
3.0%
3/99
|
2.1%
2/97
|
|
Nervous system disorders
Akathisia
|
9.2%
9/98
|
13.1%
13/99
|
2.1%
2/97
|
|
Nervous system disorders
Dizziness
|
7.1%
7/98
|
5.1%
5/99
|
1.0%
1/97
|
|
Nervous system disorders
Dystonia
|
2.0%
2/98
|
5.1%
5/99
|
0.00%
0/97
|
|
Nervous system disorders
Extrapyramidal disorder
|
12.2%
12/98
|
28.3%
28/99
|
3.1%
3/97
|
|
Nervous system disorders
Headache
|
20.4%
20/98
|
23.2%
23/99
|
18.6%
18/97
|
|
Nervous system disorders
Somnolence
|
24.5%
24/98
|
27.3%
27/99
|
3.1%
3/97
|
|
Psychiatric disorders
Anxiety, upper
|
5.1%
5/98
|
1.0%
1/99
|
3.1%
3/97
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/98
|
6.1%
6/99
|
5.2%
5/97
|
|
Psychiatric disorders
Insomnia
|
6.1%
6/98
|
1.0%
1/99
|
2.1%
2/97
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
5.1%
5/98
|
0.00%
0/99
|
2.1%
2/97
|
|
Respiratory, thoracic and mediastinal disorders
Cough, upper
|
7.1%
7/98
|
1.0%
1/99
|
4.1%
4/97
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.2%
10/98
|
3.0%
3/99
|
3.1%
3/97
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.1%
5/98
|
2.0%
2/99
|
3.1%
3/97
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PIs may not publish trial results for 18 months - 2 years after trial is completed.
- Publication restrictions are in place
Restriction type: OTHER