Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00067262
The ClinicalTrials.gov registry entry for NCT00067262 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (55% lower). The listed sponsor is Abbott, which has 181 total studies on file at ClinicalTrials.gov.
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 reports 16 study locations spanning 12 distinct geographic areas - top geographies include 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.
-
A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
RECRUITING · Phase 3
-
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
RECRUITING · Phase 3
-
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
RECRUITING · Phase 3
-
Study of Aripiprazole (Abilify) in Children With Symptoms of Mania
COMPLETED · Phase 3
-
Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression
COMPLETED · Phase 3
-
Acute Treatment of Bipolar II Depression
COMPLETED · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.