Phase 2 N=94 Randomized Quadruple-blind Treatment

A Double-Blind Placebo Controlled Trial of Riluzole in Bipolar Depression

Bipolar Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00376220 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcome: 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 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Riluzole (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: May 2010

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	—

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.

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

View full record on ClinicalTrials.gov →

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.