Riluzole to Treat Depression in Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Riluzole; Placebo
Intervention description: Riluzole; Placebo
Intervention MeSH terms: Riluzole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Riluzole; Neuroprotective; Open-Label Study; Glutamate Dysfunction; Bipolar Mood Disorder; Bipolar Disorder; Mood Disorder

Summary:

      This study examines if Riluzole, FDA approved for ALS, will improve symptoms of depression in
      Bipolar Disorder.

      Purpose: This study will examine the safety and effectiveness of riluzole (Rilutek trademark)
      for short-term treatment of depression symptoms, such as depressed mood, psychomotor
      retardation, and excessive sleeping in patients with bipolar disease. Riluzole is approved by
      the Food and Drug Administration (FDA) to treat amyotrophic lateral sclerosis (ALS, also
      known as Lou Gehrig's disease). Preliminary findings of a study using riluzole to treat acute
      depression in patients with unipolar depression indicate that it may have antidepressant
      properties in some patients.

      Patients between 18 and 70 years of age with bipolar I or II disorder without psychosis may
      be eligible for this 8-week study. Candidates must be currently depressed, must have had at
      least one previous major depressive episode, and must have failed to improve with prior
      treatment with at least one antidepressant. They will be screened with a medical history,
      physical examination, electrocardiogram (EKG), blood and urine tests, and psychiatric
      evaluation. A blood or urine sample will be analyzed for illegal drugs. Women of childbearing
      potential will have a pregnancy test.

      Participants will begin an 8-week course of treatment, starting with a placebo (a sugar pill
      formulated to look like the active drug) and, at some point, switching to riluzole. In
      addition to drug treatment, participants will undergo the following procedures:

      Physical examination and electrocardiogram (EKG) at the beginning and end of the study;

      Weekly check of vital signs (temperature, blood pressure and heart rate);

      Weekly 1-hour interviews consisting of psychiatric and psychomotor rating scales to assess
      treatment response;

      Weekly blood tests to measure blood levels of riluzole and evaluate drug side effects.

      At the end of the study, participants' psychiatric status will be reassessed and appropriate
      long-term psychiatric treatment arranged.

      Atendemos pacientes de habla hispana.

      We enroll eligible participants locally and from around the country. Travel arrangements are
      provided and costs covered by the National Institute of Mental Health (NIMH). (Arrangements
      vary by distance and by specific study.) After completing the study participants receive
      short-term follow-up care while transitioning back to a provider.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

        Male or female subjects, 18-70 years of age.

        Female subjects of childbearing potential must be using a medically accepted means of
        contraception.

        Each subject must have a level of understanding sufficient to agree to all required tests
        and examinations.

        Each subject must understand the nature of the study and must sign an informed consent
        document.

        Subjects must fulfill the criteria bipolar I or II disorder, current episode depressed
        without psychotic features as defined in the Diagnostic and Statistical Manual (DSM-IV)
        based on clinical assessment and confirmed by the Structured Clinical Interview for DSM
        (SCID-P).

        Subjects must have an initial score at Visit 1 and Visit 2 of at least 20 on the MADRS.

        Current duration of depressive episode should be at least 4 weeks.

        Subjects must have experienced, in the opinion of the investigator, at least one previous
        major depressive episode as defined in DSM-IV (not including the current major depressive
        episode).

        EXCLUSION CRITERIA:

        Presence of psychotic features.

        Female subjects who are either pregnant or nursing.

        Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory,
        cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic,
        or hematologic disease.

        Subjects with uncorrected hypothyroidism or hyperthyroidism.

        Clinically significant abnormal laboratory tests.

        Current or past blood dyscrasia.

        Documented history of hypersensitivity or intolerance to riluzole.

        DSM-IV substance abuse or dependence within the past 90 days. No alcohol or recreational
        drug use will be permitted during the study.

        Treatment with an injectable depot neuroleptic within less than one dosing interval between
        depot neuroleptic injections prior to visit 2.

        Treatment with a reversible monoamine oxidase inhibitor (MAOI), guanethidine, or guanadrel
        within 1 week or with fluoxetine within 5 weeks prior to Visit 2.

        Treatment with any other concomitant medication with primarily central nervous system (CNS)
        activity, other than specified in Appendix A.

        Treatment with clozapine or electroconvulsive therapy (ECT) within 4 weeks prior to Visit
        2.

        Current diagnosis of schizophrenia or other psychotic disorder as defined in the DSM-IV.

        Current Axis I Anxiety Disorder that is clinically significant.

        Judged clinically to be at serious suicidal risk.