Quetiapine for Bipolar Disorder and Alcohol Dependence
Condition: Bipolar Disorder; Alcohol Dependence
MeSH terms: Alcoholism; Bipolar Disorder
Intervention: Placebo; Quetiapine
Intervention description: Inactive ingredient matching the active medication in appearance.; Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: bipolar disorder; alcohol dependence; mania; manic disorder; depression

Summary:

      The purpose of this study is to find out whether an investigational drug called quetiapine
      can treat bipolar disorder, improve mood and reduce alcohol use and craving.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients with a diagnosis of bipolar I or II disorder, depressed or mixed phase on
             the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental
             Disorders (SCID) and confirmed by interview with PI or co-I.

          -  Current diagnosis of alcohol dependence.

          -  Alcohol use (by self-report) of at least 15 drinks in the 7 days prior to baseline.

          -  Currently taking a mood stabilizer defined as lithium, divalproex/valproic acid,
             oxcarbazepine, or lamotrigine at a stable dose for > 14 days.

          -  Men and women age 18-65 years old.

          -  English or Spanish speaking.

        Exclusion Criteria:

          -  Bipolar disorders other than bipolar I or II (e.g., not otherwise specified or
             cyclothymic disorders) based on the SCID and confirmed through clinical assessment by
             PI or co-I.

          -  Baseline Young Mania Rating Scale (YMRS) score > 35 or Hamilton Depression Rating
             Scale (HRSD) 17 score > 35.

          -  Current clinically significant psychotic features (hallucinations, delusions,
             disorganized thought processes).

          -  Evidence of clinically significant alcohol withdrawal symptoms defined as a Clinical
             Institute Withdrawal Assessment (CIWA-AR) score of > 8.

          -  History of hepatic cirrhosis or baseline AST or ALT > 3X upper limit of normal or
             other clinically significant findings on physical or laboratory examination.

          -  Mental retardation or other severe cognitive impairment.

          -  Prison or jail inmates.

          -  Pregnant or nursing women or women of childbearing age who will not use oral
             contraceptives, abstinence, or other acceptable methods of birth control during the
             study.

          -  Antipsychotic therapy within 14 days prior to randomization.

          -  Current carbamazepine or benzodiazepine therapy.

          -  Current treatment with medications shown to reduce alcohol consumption (naltrexone,
             acamprosate, disulfiram, or topiramate) in large randomized, controlled trials.

          -  Initiation of antidepressants or mood stabilizers or psychotherapy within past 2
             weeks.

          -  High risk for suicide, defined as any suicide attempts in the past 3 months or current
             suicidal ideation with plan and intent.

          -  Intensive outpatient treatment for substance abuse (AA, NA meetings, or other 12-step
             programs or weekly psychotherapy that started at least 14 days prior to randomization
             will be allowed).

          -  Current treatment with ketoconazole, itraconazole, erythromycin, or nefazodone.

          -  Severe or life-threatening medical condition (e.g., congestive heart failure, terminal
             cancer) or laboratory or physical examination findings consistent with serious medical
             illness (e.g., severe edema, atrial fibrillation, dangerously abnormal electrolytes).

          -  Diabetes mellitus by history or suspected from baseline blood sugar.

          -  History of cataracts or suspected cataracts on ophthalmic exam

          -  History of seizure disorder of any etiology; if a subject develops a seizure episode,
             s/he will be discontinued from the study.