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NCT00961961 · ClinicalTrials.gov registry record · Phase 4
Prevention of Relapse & Recurrence of Bipolar Depression
A Phase 4 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 4
- Development phase
- 177
- Enrollment target
NCT00961961: Completed Phase 4 study, sponsored by University of Pennsylvania.
NCT00961961 is a Phase 4 study that has completed, run by University of Pennsylvania. The registered enrollment target is 177 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00961961, a Phase 4 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 177 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether the long-term use of combined antidepressant plus mood stabilizer therapy is superior to mood stabilizer therapy alone in preventing the relapse and recurrence of bipolar depression.
Primary Outcome
Patients who were randomized to one of the Phase II conditions were interviewed once each month. If they met criteria for a relapse of a Major Depressive Episode, this was considered the study outcome. If they participated for the full year of Phase II without a documented relapse, they were considered a completer.
Interventions
- DRUG Lithium / Fluoxetine
- DRUG Lithium / Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 177 participants |
| Start Date | 2009-07-01 |
| Est. Completion | 2016-09-01 |
| Phase | Phase 4 |
What the finished NCT00961961 record still lists
NCT00961961 is an interventional study that assigns participants to a tested intervention. The registered 177 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 2 interventions - of which Lithium / Fluoxetine is the first listed.
NCT00961961 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00961961 about?
NCT00961961 is a clinical study titled "Prevention of Relapse & Recurrence of Bipolar Depression". The purpose of this study is to determine whether the long-term use of combined antidepressant plus mood stabilizer therapy is superior to mood stabilizer therapy alone in preventing the relapse and recurrence of bipolar depression.
What is the current status of trial NCT00961961?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 177 participants. The study started on 2009-07-01. Estimated completion is 2016-09-01.
What interventions are being tested in trial NCT00961961?
The interventions under investigation include: Lithium / Fluoxetine (DRUG), Lithium / Placebo (DRUG).
Who is sponsoring clinical trial NCT00961961?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00961961's enrollment target sits among peer trials
177 477th of 2000 higher than 1,524 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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