Ondansetron for Bipolar Disorder and Alcohol Use Disorders
Condition: Bipolar Disorder; Alcohol Use Disorder; Dual Diagnosis
MeSH terms: Alcoholism; Bipolar Disorder; Alcohol Drinking
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine if ondansetron, as an add-on therapy, is associated
      with reduced depressive symptoms and alcohol use in outpatients with bipolar disorder (BPD),
      cyclothymic disorder, schizoaffective disorder (bipolar type) and major depressive disorder
      (MDD) with mixed features. The investigators will also use blood samples to determine if the
      genotype for the serotonin transporter gene is associated with response to ondansetron.
    

Detailed description: 
      A total of 70 outpatients with alcohol use disorder and BPD, cyclothymic disorder,
      schizoaffective disorder (bipolar type), or MDD with mixed features will be enrolled in a
      12-week, randomized, double-blind, parallel-group, placebo-controlled study of ondansetron.
      Participant will receive either ondansetron or a placebo for 12 weeks. He or she has an equal
      chance of receiving ondansetron or placebo.

      Randomization will be stratified based on > 4 or ≤ 4 drinking days per week at start of the
      study. Ondansetron or placebo will be given at 0.5 milligrams twice a day for the first 4
      weeks. At weeks 4, 8 and 10 the dose may be increased to 1.0, 2.0 or 4.0 milligrams twice a
      day, respectively, if significant reductions in depression and alcohol use are not observed
      and the participant is not experiencing any side effects. Blood will be drawn for routine
      laboratory analyses including a complete blood count (CBC), liver panel, and
      Carbohydrate-deficient Transferrin (CDT) at baseline and weeks 4, 8 and 12.

      Each participant will return for weekly follow-up visits and repeat outcome measures. Pill
      counts will be conducted, and a list of current medications and doses will be recorded at
      each visit. Participants will be compensated at each appointment with a bus pass, gift cards,
      and a monetary incentive for compliance. Participants will be evaluated by both the research
      assistant (RA) and principal investigator (PI) at each visit.

      The Hamilton Rating Scale for Depression (HAMD) and Timeline Followback (TLFB) will be given
      at each visit as the primary outcome measures. Cognitive assessments will be performed at
      baseline and week 12.
    

Intervention name(s): Ondansetron; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ondansetron is a serotonin receptor antagonist that is FDA-approved to treat nausea and vomiting caused by cancer therapy and surgery.; Inactive ingredient matching the active medication in appearance
Other intervention name(s): Zofran; Zuplenz; Sugar-pill
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar Disorder; BPD; Alcohol Use Disorder; Alcohol Abuse; Alcohol Dependence; Ondansetron; Cognition; Mood