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Quetiapine for Bipolar Disorder and Alcohol Dependence

Information source: University of Texas Southwestern Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder; Alcohol Dependence

Intervention: Placebo (Drug); Quetiapine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Texas Southwestern Medical Center

Official(s) and/or principal investigator(s):
E. Sherwood Brown, MD PhD, Principal Investigator, Affiliation: UT Southwestern Medical Center

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.

Clinical Details

Official title: Quetiapine for Bipolar Disorder and Alcohol Dependence

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The number of standard drinks/week will serve as the primary outcome measure.

Secondary outcome: Other measures of alcohol use including heavy drinking days and gamma-glutamyl transferase levels will serve as the secondary outcome measure.

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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 Depresion 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.

Locations and Contacts

Psychoneuroendocrine Research Program, Dallas, Texas 75235, United States
Additional Information

Starting date: March 2007
Last updated: May 1, 2013

Page last updated: August 23, 2015

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