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NCT00194129 · ClinicalTrials.gov registry record · Phase 3
Lithium and Divalproex for the Treatment of Comorbid Rapid Cycling Bipolar Disorder and Substance Abuse Disorder
A Phase 3 study, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 31
- Enrollment target
NCT00194129: Completed Phase 3 study, sponsored by University Hospitals Cleveland Medical Center.
NCT00194129 is a Phase 3 study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 31 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00194129, a Phase 3 study, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 31 participants
- Enrollment target
Study Summary
This study will determine the efficacy and safety of combination therapy with divalproex and lithium for treating mania in people with rapid cycling bipolar disorder and a substance abuse disorder.
Primary Outcome
A relapse is a return to either a depressive, manic, hypomanic or mixed episode after a period of not have any symptoms.
Interventions
- DRUG Placebo
- DRUG Lithium
- DRUG Divalproex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 1997-11 |
| Est. Completion | 2006-09 |
| Phase | Phase 3 |
What the finished NCT00194129 record still lists
NCT00194129 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00194129 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00194129 about?
NCT00194129 is a clinical study titled "Lithium and Divalproex for the Treatment of Comorbid Rapid Cycling Bipolar Disorder and Substance Abuse Disorder". This study will determine the efficacy and safety of combination therapy with divalproex and lithium for treating mania in people with rapid cycling bipolar disorder and a substance abuse disorder.
What is the current status of trial NCT00194129?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 31 participants. The study started on 1997-11. Estimated completion is 2006-09.
What interventions are being tested in trial NCT00194129?
The interventions under investigation include: Placebo (DRUG), Lithium (DRUG), Divalproex (DRUG).
Who is sponsoring clinical trial NCT00194129?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00194129's enrollment target sits among peer trials
31 1914th of 2000 higher than 84 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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