Risperidone and Desipramine in Alcohol Use and Schizophrenia
Condition: Schizophrenia; Alcoholism; Dual Diagnosis
MeSH terms: Alcoholism; Schizophrenia
Intervention: Risperidone + Desipramine
Intervention MeSH terms: Risperidone; Desipramine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Alcoholism; Dual Diagnosis; Desipramine; Risperidone

Summary:

      Note: In June 2013, the study design was changed from a randomized controlled study of
      risperidone + despiramine vs. risperidone vs. placebo to an open label pre-post study of
      risperidone (or risperidone-like drug) + desipramine. The aims of the study were revised to
      read:

        1. To determine whether participants treated with risperidone in combination with
           desiprmaine have less alcohol use (fewer drinking days; fewer heavy drinking days)
           during the final 8 weeks on these medications as compared to pre-baseline. The primary
           hypothesis is that compared to pre-baseline, participants will demonstrate fewer days of
           drinking (per week), as well as fewer days of heavy drinking (per week) in the final
           eight weeks they are taking risperidone and desipramine, as recorded on the Timeline
           Follow-Back assessment

        2. To explore changes in symptoms (of schizophrenia and of depression) in the final eight
           weeks of treatment with risperidone + desipramine compared to the period before baseline

        3. To assess the side effect burden associated with the combination of these two
           medications in participants.

      The original aims of the study were:

      The purpose of this study is to determine whether participants who are treated with
      risperidone in combination with desipramine have less alcohol use (fewer drinking days; fewer
      heavy drinking days) than do participants who are treated with RISP with placebo. The primary
      hypothesis is that compared to treatment with risperidone, participants randomized to a
      combination of risperidone plus desipramine will have fewer days of drinking, as well as
      fewer days of heavy drinking. The study will also compare the effects of risperidone as
      compared to risperidone plus desipramine on participants' symptoms and side effects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Meets the diagnostic criteria of schizophrenia or schizoaffective disorder

          2. Meets the diagnostic criteria for a current alcohol use disorder (abuse or dependence)

          3. Recent alcohol use as documented on the Timeline Followback

          4. Receives outpatient treatment with oral antipsychotic medication (including
             risperidone.

          5. Is willing to switch to risperidone treatment at the beginning of the study.

        Exclusion Criteria:

          1. Other substance use disorder other than alcohol, caffeine and nicotine, and cannabis
             abuse, as defined by DSM-IV criteria.

          2. Receives current treatment with Clozapine

          3. Continues to use alcohol despite current adequate treatment with medication to
             decrease alcohol use(e.g. naltrexone, acamprosate, disulfiram or topiramate)

          4. Is determined to be a "slow metabolizer" of CYP2D6

          5. Is currently pregnant, trying to become pregnant, or nursing