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NCT00221403 · ClinicalTrials.gov registry record · Phase 3
Placebo Controlled Trial of Valproate and Risperidone in Young Children With Bipolar Disorders
A Phase 3 study of Bipolar Disorder, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 3
- Development phase
- 46
- Enrollment target
- 2
- Study locations
NCT00221403 is a Phase 3 study of Bipolar Disorder that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 46 participants, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (86% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT00221403, a Phase 3 study of Bipolar Disorder, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 46 participants
- Enrollment target
- 2
- Study locations
Study Summary
The primary aim of this proposal is to conduct a preliminary controlled trial of valproate and risperidone in children ages 3-7 yr. with bipolar disorders. A secondary aim is to carefully characterize these subjects using clinical rating scales and develop pilot data on a very young cohort of children with bipolar disorders that can be used to support an application to NIMH for a prospective, longitudinal study that will provide important information about the course, medication response, neurobiology and outcome of these patients.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Risperidone oral solution
- DRUG Valproate Oral Solution
Study Locations (2)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Wisconsin
- Children's Hospital of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2004-09 |
| Est. Completion | 2011-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00221403
The ClinicalTrials.gov registry entry for NCT00221403 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 46 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 (86% lower). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 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 Placebo is the first listed.
NCT00221403 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Ohio, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT00221403 about?
NCT00221403 is a clinical study titled "Placebo Controlled Trial of Valproate and Risperidone in Young Children With Bipolar Disorders". The primary aim of this proposal is to conduct a preliminary controlled trial of valproate and risperidone in children ages 3-7 yr. with bipolar disorders. A secondary aim is to carefully characterize these subjects using clinical rating scales and develop pilot data on a very young cohort of childr...
What is the current status of trial NCT00221403?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 46 participants. The study started on 2004-09. Estimated completion is 2011-05.
What conditions does trial NCT00221403 study?
This clinical trial studies the following conditions: Bipolar Disorder.
What interventions are being tested in trial NCT00221403?
The interventions under investigation include: Placebo (OTHER), Risperidone oral solution (DRUG), Valproate Oral Solution (DRUG).
Who is sponsoring clinical trial NCT00221403?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00221403 being conducted?
This trial has 2 study locations across Ohio, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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