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NCT00054704 · ClinicalTrials.gov registry record · Phase 2
Riluzole to Treat Depression in Bipolar Disorder
A Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
- Terminated
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT00054704 is a Phase 2 study that was terminated before completion, run by National Institute of Mental Health (NIMH). The registered enrollment target is 19 participants.
The verdict
NCT00054704, a Phase 2 study, was terminated before completion, sponsored by National Institute of Mental Health (NIMH).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study Summary
This study examines if Riluzole, FDA approved for ALS, will improve symptoms of depression in Bipolar Disorder. Purpose: This study will examine the safety and effectiveness of riluzole (Rilutek trademark) for short-term treatment of depression symptoms, such as depressed mood, psychomotor retardation, and excessive sleeping in patients with bipolar disease. Riluzole is approved by the Food and Drug Administration (FDA) to treat amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease). Preliminary findings of a study using riluzole to treat acute depression in patients with unipolar depression indicate that it may have antidepressant properties in some patients. Patients between 18 and 70 years of age with bipolar I or II disorder without psychosis may be eligible for this 8-week study. Candidates must be currently depressed, must have had at least one previous major depressive episode, and must have failed to improve with prior treatment with at least one antidepressant. They will be screened with a medical history, physical examination, electrocardiogram (EKG), blood and urine tests, and psychiatric evaluation. A blood or urine sample will be analyzed for illegal drugs. Women of childbearing potential will have a pregnancy test. Participants will begin an 8-week course of treatment, starting with a placebo (a sugar pill formulated to look like the active drug) and, at some point, switching to riluzole. In addition to drug treatment, participants will undergo the following procedures: Physical examination and electrocardiogram (EKG) at the beginning and end of the study; Weekly check of vital signs (temperature, blood pressure and heart rate); Weekly 1-hour interviews consisting of psychiatric and psychomotor rating scales to assess treatment response; Weekly blood tests to measure blood levels of riluzole and evaluate drug side effects. At the end of the study, participants' psychiatric status will be reassessed and appropriate long-term psy
Interventions
- DRUG Placebo
- DRUG Riluzole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2003-02 |
| Est. Completion | 2014-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00054704
The ClinicalTrials.gov registry entry for NCT00054704 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00054704 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00054704 about?
NCT00054704 is a clinical study titled "Riluzole to Treat Depression in Bipolar Disorder". This study examines if Riluzole, FDA approved for ALS, will improve symptoms of depression in Bipolar Disorder. Purpose: This study will examine the safety and effectiveness of riluzole (Rilutek trademark) for short-term treatment of depression symptoms, such as depressed mood, psychomotor retardat...
What is the current status of trial NCT00054704?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2003-02. Estimated completion is 2014-12.
What interventions are being tested in trial NCT00054704?
The interventions under investigation include: Placebo (DRUG), Riluzole (DRUG).
Who is sponsoring clinical trial NCT00054704?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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