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NCT00221429 · ClinicalTrials.gov registry record · Phase 3
Lithium Versus Divalproex for Treating Pediatric Bipolar Disorder
A Phase 3 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 3
- Development phase
- 153
- Enrollment target
NCT00221429: Completed Phase 3 study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT00221429 is a Phase 3 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 153 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00221429, a Phase 3 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 153 participants
- Enrollment target
Study Summary
This study compared the efficacy of lithium, divalproex, and placebo in treating the acute phase of symptomatic bipolar I disorder, mixed or manic episode, in children and adolescents.
Interventions
- OTHER Placebo
- DRUG Lithium
- DRUG sodium divalproex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2001-03 |
| Est. Completion | 2015-02 |
| Phase | Phase 3 |
What the finished NCT00221429 record still lists
NCT00221429 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00221429 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00221429 about?
NCT00221429 is a clinical study titled "Lithium Versus Divalproex for Treating Pediatric Bipolar Disorder". This study compared the efficacy of lithium, divalproex, and placebo in treating the acute phase of symptomatic bipolar I disorder, mixed or manic episode, in children and adolescents.
What is the current status of trial NCT00221429?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 153 participants. The study started on 2001-03. Estimated completion is 2015-02.
What interventions are being tested in trial NCT00221429?
The interventions under investigation include: Placebo (OTHER), Lithium (DRUG), sodium divalproex (DRUG).
Who is sponsoring clinical trial NCT00221429?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00221429's enrollment target sits among peer trials
153 1510th of 2000 higher than 488 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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