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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00057681
The ClinicalTrials.gov registry entry for NCT00057681 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 379 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 330-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (15% higher). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
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 reports 5 study locations spanning 5 distinct geographic areas - top geographies include 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.
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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.