Trial Outcomes & Findings for Aripiprazole in Adolescents With Schizophrenia (NCT NCT00102063)
NCT ID: NCT00102063
Last Updated: 2012-08-10
Results Overview
Change from baseline to last observed post-baseline value in PANSS total score, using the last observation carried forward. This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point scale of severity with 1 being absent to 7 being extreme. Minimum score is 30 which is best outcome; maximum score is 210 for worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
302 participants
Primary outcome timeframe
Baseline and Day 42
Results posted on
2012-08-10
Participant Flow
Participants were recruited from 101 centers in the United States, Europe, South America, the Caribbean, and South Africa between August 2004 and August 2006.
Participants were screened over a 4-week period.
Participant milestones
| Measure |
Aripiprazole 10 mg/Day Group
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 allowed after Day 25
|
Aripiprazole 30 mg/Day Group
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, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
|
Placebo Group
Participants were given a single pill administered once daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
100
|
102
|
100
|
|
Overall Study
COMPLETED
|
84
|
84
|
90
|
|
Overall Study
NOT COMPLETED
|
16
|
18
|
10
|
Reasons for withdrawal
| Measure |
Aripiprazole 10 mg/Day Group
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 allowed after Day 25
|
Aripiprazole 30 mg/Day Group
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, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
|
Placebo Group
Participants were given a single pill administered once daily
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
5
|
1
|
1
|
|
Overall Study
Adverse Event
|
7
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
12
|
5
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
Baseline Characteristics
Aripiprazole in Adolescents With Schizophrenia
Baseline characteristics by cohort
| Measure |
Aripiprazole 10 mg/Day Group
n=100 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 allowed after Day 25
|
Aripiprazole 30 mg/Day Group
n=102 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, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
|
Placebo Group
n=100 Participants
Participants were given a single pill administered once daily
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
15.6 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
15.4 years
STANDARD_DEVIATION 1.4 • n=7 Participants
|
15.4 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
15.5 years
STANDARD_DEVIATION 1.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
131 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
171 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
180 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 42Change from baseline to last observed post-baseline value in PANSS total score, using the last observation carried forward. This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point scale of severity with 1 being absent to 7 being extreme. Minimum score is 30 which is best outcome; maximum score is 210 for worse outcome.
Outcome measures
| Measure |
Aripiprazole 10 mg/Day Group
n=99 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 allowed after Day 25
|
Aripiprazole 30 mg/Day Group
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, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
|
Placebo Group
n=98 Participants
Participants were given a single pill administered once daily
|
|---|---|---|---|
|
Change in Positive and Negative Syndrome Scale (PANSS) Total Score
|
-26.7 points
Standard Error 1.9
|
-28.6 points
Standard Error 0.9
|
-21.2 points
Standard Error 1.9
|
SECONDARY outcome
Timeframe: Baseline and Day 42Change from baseline to last observed post-baseline value in PANSS positive subscale score, using the last observation carried forward. Scale consists of 7 positive symptom constructs each to be rated on a 7- point scale of severity with 1 = absent to 7 = extreme. Minimum score is 7 which is best outcome; maximum score is 49 for worse outcome.
Outcome measures
| Measure |
Aripiprazole 10 mg/Day Group
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 allowed after Day 25
|
Aripiprazole 30 mg/Day Group
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, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
|
Placebo Group
n=97 Participants
Participants were given a single pill administered once daily
|
|---|---|---|---|
|
Change in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score
|
-7.6 points
Standard Error 0.6
|
-8.1 points
Standard Error 0.6
|
-5.6 points
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Baseline and Day 42Change from baseline to last observed post-baseline value in PANSS Negative Subscale score, using the last observation carried forward. Scale consists of 7 negative symptom constructs each to be rated on a 7- point scale of severity with 1 = absent to 7 = extreme. Minimum score is 7 which is best outcome; maximum score is 49 for worse outcome.
Outcome measures
| Measure |
Aripiprazole 10 mg/Day Group
n=99 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 allowed after Day 25
|
Aripiprazole 30 mg/Day Group
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, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
|
Placebo Group
n=98 Participants
Participants were given a single pill administered once daily
|
|---|---|---|---|
|
Change in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score
|
-6.9 points
Standard Error 0.6
|
-6.6 points
Standard Error 0.6
|
-5.4 points
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Baseline and Day 42Change from baseline to last observed post-baseline value in CGI severity score, using the last observation carried forward. Scale refers to the global impression of the subject with respect to severity of the illness. The scale rates the subject's severity of illness from 0 (not rated) to 1 (least severe) to 7 (most severe).
Outcome measures
| Measure |
Aripiprazole 10 mg/Day Group
n=99 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 allowed after Day 25
|
Aripiprazole 30 mg/Day Group
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, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
|
Placebo Group
n=98 Participants
Participants were given a single pill administered once daily
|
|---|---|---|---|
|
Change in Clinical Global Impression (CGI) Severity Score
|
-1.2 points
Standard Error 0.1
|
-1.3 points
Standard Error 0.1
|
-0.9 points
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline and Day 42Last observed post-baseline value in CGI improvement score, using the last observation carried forward. Scale refers to the global impression of the subject with respect to improvement of the illness. The scale rates the subject's severity of illness from 0 (not rated) to 1 (least severe) to 7 (most severe).
Outcome measures
| Measure |
Aripiprazole 10 mg/Day Group
n=99 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 allowed after Day 25
|
Aripiprazole 30 mg/Day Group
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, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
|
Placebo Group
n=98 Participants
Participants were given a single pill administered once daily
|
|---|---|---|---|
|
Clinical Global Impression (CGI) Improvement Score
|
2.7 points
Standard Error 0.1
|
2.5 points
Standard Error 0.1
|
3.1 points
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline and Day 42Change from baseline to last observed post-baseline value in CGAS score, using the last observation carried forward. Scale 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 Group
n=99 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 allowed after Day 25
|
Aripiprazole 30 mg/Day Group
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, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
|
Placebo Group
n=98 Participants
Participants were given a single pill administered once daily
|
|---|---|---|---|
|
Change in Children's Global Assessment Scale (CGAS) Score
|
14.7 points
Standard Error 1.5
|
14.8 points
Standard Error 1.3
|
9.8 points
Standard Error 1.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Day 42Change from baseline to last observed post-baseline value in PQLES total score, using the last observation carried forward. Scale consists of 14 items pertaining to daily life activities and satisfaction, and an overall assessment item. Each item will be rated on a five-point scale (1=very poor, 2=poor, 3=fair, 4=good, 5=very good) with a minimum score of 14 (better outcome) and a maximum score of 70 (worse outcome).
Outcome measures
| Measure |
Aripiprazole 10 mg/Day Group
n=99 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 allowed after Day 25
|
Aripiprazole 30 mg/Day Group
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, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
|
Placebo Group
n=98 Participants
Participants were given a single pill administered once daily
|
|---|---|---|---|
|
Change in Pediatric Quality of Life Enjoyment and Satisfaction (PQLES) Questionnaire Total Score
|
5.2 points
Standard Error 0.9
|
5.9 points
Standard Error 0.9
|
4.5 points
Standard Error 0.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Day 42The number of subjects achieving remission. Remission was defined as a score of mild or less (≤ 3) for items P1, P2, P3, N1, N4, N6, G5, and G9 in the PANSS score.
Outcome measures
| Measure |
Aripiprazole 10 mg/Day Group
n=99 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 allowed after Day 25
|
Aripiprazole 30 mg/Day Group
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, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
|
Placebo Group
n=98 Participants
Participants were given a single pill administered once daily
|
|---|---|---|---|
|
Patients Achieving Remission
|
53 participants
|
56 participants
|
35 participants
|
Adverse Events
Aripiprazole 10 mg/Day Group
Serious events: 4 serious events
Other events: 71 other events
Deaths: 0 deaths
Aripiprazole 30 mg/Day Group
Serious events: 4 serious events
Other events: 74 other events
Deaths: 0 deaths
Placebo Group
Serious events: 3 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aripiprazole 10 mg/Day Group
n=100 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 allowed after Day 25
|
Aripiprazole 30 mg/Day Group
n=102 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, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
|
Placebo Group
n=100 participants at risk
Participants were given a single pill administered once daily
|
|---|---|---|---|
|
Infections and infestations
Varicella
|
0.00%
0/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
0.98%
1/102 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
0.00%
0/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
0.00%
0/102 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
1.0%
1/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
0.00%
0/102 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
1.0%
1/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
|
Nervous system disorders
Extrapyramidal disorder
|
1.0%
1/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
0.00%
0/102 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
0.00%
0/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
|
Nervous system disorders
Neuroleptic malignant syndrome
|
1.0%
1/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
0.00%
0/102 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
0.00%
0/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
|
Psychiatric disorders
Aggression
|
1.0%
1/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
0.00%
0/102 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
0.00%
0/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
|
Psychiatric disorders
Depression
|
0.00%
0/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
0.98%
1/102 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
0.00%
0/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
|
Psychiatric disorders
Psychotic disorder
|
1.0%
1/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
0.98%
1/102 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
1.0%
1/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
|
Psychiatric disorders
Schizophrenia
|
1.0%
1/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
0.98%
1/102 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
0.00%
0/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
0.98%
1/102 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
0.00%
0/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
0.00%
0/102 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
1.0%
1/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
0.98%
1/102 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
0.00%
0/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
Other adverse events
| Measure |
Aripiprazole 10 mg/Day Group
n=100 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 allowed after Day 25
|
Aripiprazole 30 mg/Day Group
n=102 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, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
|
Placebo Group
n=100 participants at risk
Participants were given a single pill administered once daily
|
|---|---|---|---|
|
Nervous system disorders
Tremor
|
2.0%
2/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
11.8%
12/102 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
2.0%
2/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
|
Psychiatric disorders
Agitation
|
1.0%
1/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
2.9%
3/102 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
5.0%
5/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
|
Gastrointestinal disorders
Nausea
|
9.0%
9/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
9.8%
10/102 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
6.0%
6/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
5/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
2.9%
3/102 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
5.0%
5/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
5/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
4.9%
5/102 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
4.0%
4/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
|
Nervous system disorders
Akathisia
|
5.0%
5/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
4.9%
5/102 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
12.0%
12/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
|
Nervous system disorders
Dizziness
|
7.0%
7/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
3.9%
4/102 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
3.0%
3/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
|
Nervous system disorders
Extrapyramidal disorder
|
13.0%
13/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
21.6%
22/102 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
5.0%
5/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
|
Nervous system disorders
Headache
|
16.0%
16/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
10.8%
11/102 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
10.0%
10/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
|
Nervous system disorders
Somnolence
|
11.0%
11/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
21.6%
22/102 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
6.0%
6/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
|
Psychiatric disorders
Insomnia
|
11.0%
11/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
9.8%
10/102 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
15.0%
15/100 • Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
|
Additional Information
Margaretta Nyilas
Otsuka Pharmaceutical Development & Commercialization, Inc.
Phone: 609-452-5673
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place