Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00110461 · ClinicalTrials.gov registry record · Phase 3
Aripiprazole in Children and Adolescents With Bipolar I Disorder
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 296
- Enrollment target
NCT00110461: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT00110461 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 296 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00110461, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 296 participants
- Enrollment target
Study 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.
Primary Outcome
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).
Interventions
- DRUG placebo
- DRUG Aripiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 296 participants |
| Start Date | 2005-03 |
| Est. Completion | 2007-02 |
| Phase | Phase 3 |
What the finished NCT00110461 record still lists
NCT00110461 is an interventional study that assigns participants to a tested intervention. The registered 296 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00110461 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00110461 about?
NCT00110461 is a clinical study titled "Aripiprazole in Children and Adolescents With Bipolar I Disorder". 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.
What is the current status of trial NCT00110461?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 296 participants. The study started on 2005-03. Estimated completion is 2007-02.
What interventions are being tested in trial NCT00110461?
The interventions under investigation include: placebo (DRUG), Aripiprazole (DRUG).
Who is sponsoring clinical trial NCT00110461?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00110461's enrollment target sits among peer trials
296 1164th of 2000 higher than 835 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05563792 · 296 participants · NA
Options for Pain Management Using Nonpharmacological Strategies
- NCT06828445 · 296 participants · Phase 1
Increasing Affordable Fruits and Vegetables for Families With Food Insecurity
- NCT06920563 · 296 participants · NA
Remote Postpartum Blood Pressure Monitoring and Cardiovascular Education
- NCT06309160 · 297 participants · NA
COMPASS Across Settings (CAST) for Improving Transition Outcomes for Students With ASD
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia