Phase 2
Completed N=94
A Double-Blind Placebo Controlled Trial of Riluzole in Bipolar Depression
Source: ClinicalTrials.gov NCT00376220 ↗Enrolled (actual)
94
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Mean Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to the End of 8 Weeks of Therapy. — 32.4; 30.4; 21.7; 19.0 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to the End of 8 Weeks of Therapy. |
32.4; 30.4; 21.7; 19.0 | — |
Eligibility Criteria
Inclusion Criteria
- Ages 18-75
- Diagnosed with Bipolar I or II disorder and currently depressed
- Tried at least one antidepressant during the current episode of depression
- Currently taking either lithium, depakote, or tegretol
- Currently in outpatient treatment with a psychiatrist
Exclusion Criteria
- Current psychotic symptoms
- Women who are pregnant or nursing
- Any serious, uncontrolled medical illness
- History of liver problems
- Current or past blood diseases
- Current drug or alcohol abuse
- Currently receiving Electroconvulsive Shock Therapy (ECT)
- Judged to be at serious suicidal risk
Data sourced from ClinicalTrials.gov (NCT00376220). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.