Quetiapine for Bipolar Disorder and Alcohol Dependence

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Ethanol; Quetiapine Fumarate

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.