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

Phase 2

Completed

• Conditions: Bipolar Disorder
• Interventions: Other: Placebo; Drug: Riluzole

• Registration Number: NCT00376220
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2006-09-13
• Study First Submitted QC: 2006-09-13
• Study First Posted: 2006-09-14
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2016-09-20
• Status Verified: 2017-02
• Results First Submitted QC: 2017-02-28
• Last Update Submitted: 2017-02-28
• Results First Posted: 2017-04-11
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Initially dispensed 50mg capsules to take BID. At two weeks increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS \< 12) the dose will not be increased further unless clinical symptoms recur.
1	Riluzole	Drug: Riluzole Initially dispensed 50 mg capsules to take twice a day (BID). At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules in the morning (qAM), two capsules in the evening (qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as Montgomery Asberg Depression Rating Scale (MADRS) \< 12) the dose will not be increased further unless clinical symptoms recur. Other Names: • Rilutek

Primary Outcome Measures

Name	Time	Method
Mean Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to the End of 8 Weeks of Therapy.	8 weeks	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.

Trial Locations

Locations (1)

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States