Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Bipolar Disorder, sponsored by Children's Hospital Medical Center, Cincinnati.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Young Mania Rating Scale (YMRS) total scores change from baseline by treatment group. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms.
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 |
What the finished NCT00221403 record still lists
NCT00221403 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (86% lower).
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 a single indexed study location in 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.
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 NCT00221403's enrollment target sits among peer trials
46 116th of 162 higher than 46 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
-
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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01890590 · 46 participants · NA
A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma
- NCT03191149 · 46 participants · Phase 2
Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
- NCT03510208 · 46 participants · Phase 1
Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery
- NCT04048278 · 46 participants · Early Phase 1
Lidocaine Infusion in Pancreatic Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia