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NCT00057681 · ClinicalTrials.gov registry record · Phase 3
Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents
A Phase 3 study of Bipolar Disorder, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 3
- Development phase
- 379
- Enrollment target
- 5
- Study locations
NCT00057681: Completed Phase 3 study of Bipolar Disorder, sponsored by Washington University School of Medicine.
NCT00057681 is a Phase 3 study of Bipolar Disorder that has completed, run by Washington University School of Medicine. The registered enrollment target is 379 participants, above the 330-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (15% higher). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00057681, a Phase 3 study of Bipolar Disorder, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 379 participants
- Enrollment target
- 5
- Study locations
Study Summary
This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar disorder or symptoms of mania.
Primary Outcome
The Clinical Global Impressions-Bipolar (CGI-BP) assessment instrument measured improvement in mania, depression, and overall bipolar illness. The primary outcome measure was mania improvement, which measured the change in mania from baseline. Scores were 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.
Conditions Studied
Interventions
- DRUG Risperidone
- DRUG Valproate
- DRUG Lithium carbonate
Study Locations (5)
District of Columbia
- Children's National Medical Center - Washington D.C.
Maryland
- Johns Hopkins Medical Center - Baltimore
Missouri
- Washington University School of Medicine - St Louis
Pennsylvania
- University of Pittsburgh/WPIC - Pittsburgh
Texas
- University of Texas - Galveston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 379 participants |
| Start Date | 2003-02 |
| Est. Completion | 2008-12 |
| Phase | Phase 3 |
What the finished NCT00057681 record still lists
NCT00057681 is an interventional study that assigns participants to a tested intervention. The registered 379 participants enrollment target is mid-sized for trials with a published cap, above the 330-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (15% higher).
The record links to 1 condition, with Bipolar Disorder appearing as the primary indexed condition, and to 3 interventions - of which Risperidone is the first listed.
NCT00057681 lists 5 locations in 5 states (District of Columbia, Maryland, Missouri).
Frequently Asked Questions
What is clinical trial NCT00057681 about?
NCT00057681 is a clinical study titled "Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents". This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar disorder or symptoms of mania.
What is the current status of trial NCT00057681?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 379 participants. The study started on 2003-02. Estimated completion is 2008-12.
What conditions does trial NCT00057681 study?
This clinical trial studies the following conditions: Bipolar Disorder.
What interventions are being tested in trial NCT00057681?
The interventions under investigation include: Risperidone (DRUG), Valproate (DRUG), Lithium carbonate (DRUG).
Who is sponsoring clinical trial NCT00057681?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00057681 being conducted?
This trial has 5 study locations across District of Columbia, Maryland, Missouri, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00057681's enrollment target sits among peer trials
379 21st of 162 higher than 142 of 162 other Bipolar Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar Disorder 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
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