Bipolar Depression Research Study

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00376220
• Other study ID #: 04-04-23-10
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2006
• Last updated: June 22, 2011
• Start date: May 2004
• Est. completion date: May 2010

Study information

• Verified date: January 2011
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Riluzole
Initially dispensed 50 mg 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.

Other:
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Stanley Medical Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline to the end of 8 weeks of therapy. Response will be defined as a > 50% reduction in MADRS score from baseline.		8 weeks	No
Secondary	Change in the CGI, rates of full remission as defined by a MADRS score < 12, rates of hypomanic/manic symptoms using the YMRS, clinical data as predictors of treatment response, smoking as a factor that may limit effectiveness.		8 weeks	No