Quetiapine for Bipolar Disorder and Alcohol Dependence

NCT ID: NCT00457197

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2011-07-31

Brief 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.

Detailed Description

The primary aim in the study is to determine if quetiapine treatment is associated with greater reduction in alcohol use than placebo in outpatients with bipolar disorder and alcohol dependence. We will also examine if quetiapine treatment is associated with greater reduction in alcohol craving than placebo in outpatients with bipolar disorder and alcohol dependence and if quetiapine treatment is associated with greater improvement in depressive symptoms than placebo in outpatients with bipolar disorder and alcohol dependence.

Conditions

Bipolar Disorder; Alcohol Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Inactive ingredient matching the active medication in appearance.

Quetiapine

This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.

Group Type: ACTIVE_COMPARATOR

Quetiapine

Intervention Type: DRUG

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.

Interventions

Placebo

Inactive ingredient matching the active medication in appearance.

Intervention Type: DRUG

Quetiapine

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 Type: DRUG

Other Intervention Names

Sugar-pill; Seroquel; Xeroquel; Ketipinor

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

E. Sherwood Brown, MD PhD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

Psychoneuroendocrine Research Program

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU 072010-090

Identifier Type: -

Identifier Source: org_study_id