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NCT00376220 · ClinicalTrials.gov registry record · Phase 2
A Double-Blind Placebo Controlled Trial of Riluzole in Bipolar Depression
A Phase 2 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 2
- Development phase
- 94
- Enrollment target
NCT00376220: Completed Phase 2 study, sponsored by Johns Hopkins University.
NCT00376220 is a Phase 2 study that has completed, run by Johns Hopkins University. The registered enrollment target is 94 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00376220, a Phase 2 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 94 participants
- Enrollment target
Study Summary
The Johns Hopkins Department of Psychiatry is conducting a research study to examine the effectiveness of riluzole in treating the depressed phase of bipolar disorder. This outpatient treatment study of medication or placebo will last 9-12 weeks. The study includes medical and psychiatric evaluations as well as time-limited medication treatment at no cost, and you will be compensated for your participation.
Primary Outcome
The Montgomery Asberg Depression Rating Scale measures symptoms of depression (MADRS) is a semi-structured interview rating scale for depression that assesses 10 symptoms. The scale is composed of 10 questions with a fixed 7 point scale (0-6). Total score ranges from 0-60. A higher score indicates more depressive symptoms. MADRS Response will be defined as a \> 50% reduction in MADRS score from baseline.
Interventions
- OTHER Placebo
- DRUG Riluzole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2004-05 |
| Est. Completion | 2010-05 |
| Phase | Phase 2 |
What the finished NCT00376220 record still lists
NCT00376220 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00376220 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00376220 about?
NCT00376220 is a clinical study titled "A Double-Blind Placebo Controlled Trial of Riluzole in Bipolar Depression". The Johns Hopkins Department of Psychiatry is conducting a research study to examine the effectiveness of riluzole in treating the depressed phase of bipolar disorder. This outpatient treatment study of medication or placebo will last 9-12 weeks. The study includes medical and psychiatric evaluation...
What is the current status of trial NCT00376220?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 94 participants. The study started on 2004-05. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00376220?
The interventions under investigation include: Placebo (OTHER), Riluzole (DRUG).
Who is sponsoring clinical trial NCT00376220?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00376220's enrollment target sits among peer trials
94 764th of 2000 higher than 1,235 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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