Quetiapine for Bipolar Disorder and Alcohol Dependence

NCT00457197 | Completed Phase 4 Results DMC

• 1 other identifier: STU 072010-090
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Alcohol Dependence

Keywords

bipolar disorder; alcohol dependence; mania; manic disorder; depression

Outcome Measures

Primary Outcomes (1)

• The Number of Standard Drinks/Day Will Serve as the Primary Outcome Measure.

  12 weeks

Secondary Outcomes (8)

• Percent of Heavy Drinking Days

  12 weeks

• Gamma-glutamyltransferase (GGT)

  12 weeks

• Aspartate Aminotransferase (AST)

  12 weeks

• Alanine Aminotransferase (ALT)

  12 weeks

• Hamilton Rating Scale for Depression (HRSD)

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Quetiapine

ACTIVE COMPARATOR

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.

Drug: Quetiapine

Interventions

Placebo DRUG

Inactive ingredient matching the active medication in appearance.

Also known as: Sugar-pill

Placebo

Quetiapine 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.

Also known as: Seroquel, Xeroquel, Ketipinor

Quetiapine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Psychoneuroendocrine Research Program

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Alcoholism; Mania; Depression

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Larger sample size possibly needed for between-group differences in outcome measures. Pill counts not an optimum measure of medication adherence.

Results Point of Contact

• Title: E. Sherwood Brown, M.D., Ph.D., Professor
• Organization: The University of Texas Southwestern Medical Center

sherwood.brown@utsouthwestern.edu

214-645-6950

Study Officials

• E. Sherwood Brown, MD PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2007
• First Posted: April 6, 2007
• Study Start: March 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 25, 2025
• Results First Posted: January 28, 2016

Record last verified: 2025-07

Locations

US (1)