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NCT00067262 · ClinicalTrials.gov registry record · Phase 3
An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents
A Phase 3 study of Bipolar Disorder, sponsored by Abbott.
- Completed
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
- 16
- Study locations
NCT00067262: Completed Phase 3 study of Bipolar Disorder, sponsored by Abbott.
NCT00067262 is a Phase 3 study of Bipolar Disorder that has completed, run by Abbott. The registered enrollment target is 150 participants, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (55% lower). The trial reports 16 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00067262, a Phase 3 study of Bipolar Disorder, has completed, sponsored by Abbott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
- 16
- Study locations
Study Summary
The purpose of this study is to determine the safety and effectiveness of Depakote ER (Divalproex Sodium Extended-Release Tablets) compared to placebo in the treatment of bipolar disorder, manic or mixed type in children and adolescents ages 10-17 years.
Conditions Studied
Interventions
- DRUG Divalproex Sodium Extended-Release Tablets
Study Locations (16)
Florida
- - Altamonte Springs
- Professional Clinical Research, Inc. - Miami
- Segal Institute for Clinical Research - North Miami
Louisiana
- LSU - Health Science Center - New Orleans
- Brentwood Research Institute - Shreveport
Texas
- University of Texas Medical Branch - Galveston
- University of Texas Medical Branch - Houston
California
- Stanford University - Stanford
District of Columbia
- Childrens National Medical Center - Washington D.C.
Idaho
- Mountain West Clinical Trials - Boise
Illinois
- Capstone Clinical Research - Libertyville
Kansas
- Cientifica Inc at Praire View, Inc. - Newton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2003-03 |
| Phase | Phase 3 |
What the finished NCT00067262 record still lists
NCT00067262 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Bipolar Disorder appearing as the primary indexed condition, and to 1 intervention - of which Divalproex Sodium Extended-Release Tablets is the first listed.
NCT00067262 lists 16 locations in 12 states (Florida, Louisiana, Texas).
Frequently Asked Questions
What is clinical trial NCT00067262 about?
NCT00067262 is a clinical study titled "An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents". The purpose of this study is to determine the safety and effectiveness of Depakote ER (Divalproex Sodium Extended-Release Tablets) compared to placebo in the treatment of bipolar disorder, manic or mixed type in children and adolescents ages 10-17 years.
What is the current status of trial NCT00067262?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2003-03.
What conditions does trial NCT00067262 study?
This clinical trial studies the following conditions: Bipolar Disorder.
What interventions are being tested in trial NCT00067262?
The interventions under investigation include: Divalproex Sodium Extended-Release Tablets (DRUG).
Who is sponsoring clinical trial NCT00067262?
This trial is sponsored by Abbott, which has 181 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00067262 being conducted?
This trial has 16 study locations across California, District of Columbia, Florida, Idaho, Illinois. 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 NCT00067262's enrollment target sits among peer trials
150 47th of 162 higher than 114 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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