Phase 3
N=296
Aripiprazole in Children and Adolescents With Bipolar I Disorder
Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00110461 ↗Enrolled (actual)
296
Serious AEs
6.1%
Results posted
May 2012
Primary outcome: Primary: Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4 — -14.04; -16.16; -8.67 points — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aripiprazole (Drug); placebo (Drug)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Feb 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4 |
-14.04; -16.16; -8.67 | <0.0001 sig |
| SECONDARY Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 30 |
-13.91; -14.6; -8.69 | <0.0001 sig |
| SECONDARY Change in Children's Global Assessment Scale (CGAS) Total Score at Week 4 |
14.97; 16.96; 6.21 | <0.0001 sig |
| SECONDARY Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4 |
-1.6; -2.02; -0.89 | <0.0001 sig |
| SECONDARY Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 4 |
-7.65; -5.97; -4.66 | 0.0767 |
| SECONDARY Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 4 |
-9.66; -9.1; -4.63 | <0.0001 sig |
| SECONDARY Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 4 |
-12.03; -11.61; -4.57 | <0.0001 sig |
| SECONDARY Change in Children's Global Assessment (CGAS) Total Score at Week 30 |
15.81; 16.28; 7.45 | <0.0001 sig |
| SECONDARY Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30 |
-1.63; -1.93; -1.03 | 0.0003 sig |
| SECONDARY Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4 |
-0.86; -0.9; -0.57 | 0.0878 |
| SECONDARY Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30 |
-0.71; -0.94; -0.47 | 0.2553 |
| SECONDARY Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4 |
-1.6; -1.91; -0.84 | <0.0001 sig |
| SECONDARY Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30 |
-1.59; -1.75; -0.91 | <0.0001 sig |
| SECONDARY Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 30 |
-6.47; -4.39; -3.81 | 0.1729 |
| SECONDARY Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 30 |
-8.76; -8.48; -5 | <0.0001 sig |
| SECONDARY Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 4 |
-6.51; -6.52; -4.57 | 0.0468 sig |
| SECONDARY Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 30 |
-6.82; -7.84; -5.23 | 0.1309 |
| SECONDARY Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 4 |
-6.12; -3.71; -3.92 | 0.0430 sig |
| SECONDARY Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 30 |
-5.17; -3.71; -3.03 | 0.9418 |
| SECONDARY Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 4 |
0; -3.24; -3.11 | 0.9418 |
| SECONDARY Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 30 |
-4.45; -4.38; -2.7 | 0.3969 |
| SECONDARY Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 30 |
-11.04; -9.76; -5.58 | <0.0001 sig |
| SECONDARY Subject Response to Treatment at Week 4 |
44.79; 63.64; 26.09 | 0.0074 sig |
| SECONDARY Subject Response to Treatment at Week 30 |
50.00; 55.56; 26.60 | 0.0009 sig |
| SECONDARY Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4 |
2.4; 2.32; 3.37 | <0.0001 sig |
| SECONDARY Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30 |
2.61; 2.45; 3.26 | 0.0020 sig |
| SECONDARY Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4 |
2.96; 3.06; 3.57 | 0.0010 sig |
| SECONDARY Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30 |
3.3; 3.06; 3.56 | 0.1726 |
| SECONDARY Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4 |
2.48; 2.41; 3.47 | <0.0001 sig |
| SECONDARY Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30 |
2.75; 2.6; 3.38 | 0.0030 sig |
Summary
The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.
Eligibility Criteria
Inclusion Criteria
- Child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features
Exclusion Criteria
- Patients with certain other psychological disorders
- Patients with a co-morbid serious, uncontrolled systemic illness
- Patients with significant risk of committing suicide
Data sourced from ClinicalTrials.gov (NCT00110461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.