A Double-Blind Placebo Controlled Trial of Riluzole in Bipolar Depression
Condition: Bipolar Disorder
MeSH terms: Depression; Bipolar Disorder
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Riluzole; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 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.
Other intervention name(s): Rilutek
Intervention MeSH terms: Riluzole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar; Depression