Clinical trial NCT00376220: A Double-Blind Placebo Controlled Trial of Riluzole in Bipolar Depression
Official title: A Double-Blind Placebo Controlled Trial of Riluzole in Bipolar Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bipolar Disorder
Keywords: Bipolar
Depression
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Stanley Medical Research Institute
First posted: 2006-09-14
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The study will last 8 to 12 weeks and requires weekly visits. Participants will come to Johns Hopkins for a screening visit during which they will talk with a psychiatrist, answer questions about their mood and symptoms, have their blood drawn and have a brief physical exam. If they meet criteria for the study, any antidepressant medication that they are taking will be tapered and stopped before beginning study medications. Participation in the study includes free study medication, labs, and testing plus reimbursement for transportation. Participants will also be paid and after the study referred back to their treating psychiatrist with treatment recommendations.

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

Primary outcomes:
measure: Mean Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to the End of 8 Weeks of Therapy.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Jennifer L Payne, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zarate CA Jr, Quiroz JA, Singh JB, Denicoff KD, De Jesus G, Luckenbaugh DA, Charney DS, Manji HK. An open-label trial of the glutamate-modulating agent riluzole in combination with lithium for the treatment of bipolar depression. Biol Psychiatry. 2005 Feb 15;57(4):430-2. doi: 10.1016/j.biopsych.2004.11.023.
citation: Zarate CA Jr, Payne JL, Quiroz J, Sporn J, Denicoff KK, Luckenbaugh D, Charney DS, Manji HK. An open-label trial of riluzole in patients with treatment-resistant major depression. Am J Psychiatry. 2004 Jan;161(1):171-4. doi: 10.1176/appi.ajp.161.1.171.