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NCT00221975 · ClinicalTrials.gov registry record · Phase 3
Combination Therapy in Dual Diagnosis Bipolar Rapid Cycling
A Phase 3 study, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 98
- Enrollment target
NCT00221975: Completed Phase 3 study, sponsored by University Hospitals Cleveland Medical Center.
NCT00221975 is a Phase 3 study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 98 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00221975, a Phase 3 study, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 98 participants
- Enrollment target
Study Summary
Combination Therapy in Dual Diagnosis Bipolar Rapid Cycling: This study recruits males and females age 18 and older who currently meet diagnostic criteria for rapid cycling bipolar disorder (type I or II) and who have met the criteria for substance abuse or dependence of cocaine, marijuana and/or alcohol within the past six months. Patients begin treatment with a combination of lithium and divalproex. Once these medications are tolerated, they are randomly assigned to double-blind treatment with lamotrigine or placebo. Patients remain in this study until they experience a marked bimodal response for four consecutive weeks. This study is sponsored by the Stanley Foundation.
Interventions
- DRUG Lamotrigine
- DRUG Lithium
- DRUG Divalproex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2002-07 |
| Est. Completion | 2007-12 |
| Phase | Phase 3 |
What the finished NCT00221975 record still lists
NCT00221975 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Lamotrigine is the first listed.
NCT00221975 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00221975 about?
NCT00221975 is a clinical study titled "Combination Therapy in Dual Diagnosis Bipolar Rapid Cycling". Combination Therapy in Dual Diagnosis Bipolar Rapid Cycling: This study recruits males and females age 18 and older who currently meet diagnostic criteria for rapid cycling bipolar disorder (type I or II) and who have met the criteria for substance abuse or dependence of cocaine, marijuana and/or al...
What is the current status of trial NCT00221975?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 98 participants. The study started on 2002-07. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00221975?
The interventions under investigation include: Lamotrigine (DRUG), Lithium (DRUG), Divalproex (DRUG).
Who is sponsoring clinical trial NCT00221975?
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 NCT00221975's enrollment target sits among peer trials
98 1714th of 2000 higher than 283 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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