A Double-Blind Placebo Controlled Trial of Riluzole in Bipolar Depression
Condition: Bipolar Disorder
MeSH terms: Depression; Bipolar Disorder
Intervention: Riluzole; Placebo
Intervention description: 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.; 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.
Intervention MeSH terms: Riluzole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 94.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Bipolar; Depression

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