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Quetiapine for Bipolar Disorder and Alcohol Dependence

This study is currently recruiting participants.
Verified by University of Texas Southwestern Medical Center, April 2007

Sponsored by: University of Texas Southwestern Medical Center
Information provided by: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00457197
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Alcohol Dependence
Drug: Quetiapine
Phase IV

MedlinePlus related topics:   Alcoholism    Bipolar Disorder   

ChemIDplus related topics:   Quetiapine    Quetiapine fumarate    Ethanol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Quetiapine for Bipolar Disorder and Alcohol Dependence

Further study details as provided by University of Texas Southwestern Medical Center:

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

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

Estimated Enrollment:   120
Study Start Date:   March 2007

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
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Outpatients with a diagnosis of bipolar I or II disorder, depressed or mixed phase on the 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., NOS or cyclothymic disorders) based on the SCID and confirmed through clinical assessment by PI or co-I.
  • Baseline YMRS score > 35 or HRSD17 score > 35.
  • Current clinically significant psychotic features (hallucinations, delusions, disorganized thought processes).
  • Evidence of clinically significant alcohol withdrawal symptoms defined as a 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457197

Contacts
Contact: Jeremy Thurmon, BS     214-645-6963     jeremy.thurmon@utsouthwestern.edu    
Contact: Barry Gabrielson, BS     214-645-6967     barry.gabrielson@utsouthwestern.edu    

Locations
United States, Texas
Psychoneuroendocrine Research Program     Recruiting
      Dallas, Texas, United States, 75235

Sponsors and Collaborators
University of Texas Southwestern Medical Center

Investigators
Principal Investigator:     E. Sherwood Brown, MD PhD     UT Southwestern Medical Center    
  More Information

Study ID Numbers:   112006-046
First Received:   April 4, 2007
Last Updated:   April 5, 2007
ClinicalTrials.gov Identifier:   NCT00457197
Health Authority:   United States: Food and Drug Administration

Keywords provided by University of Texas Southwestern Medical Center:
bipolar disorder  
alcohol dependence  
mania  
manic disorder
mania
depression

Study placed in the following topic categories:
Depression
Bipolar Disorder
Disorders of Environmental Origin
Depressive Disorder
Affective Disorders, Psychotic
Quetiapine
Mental Disorders
Alcoholism
Substance-Related Disorders
Mood Disorders
Alcohol-Related Disorders
Psychotic Disorders
Ethanol

Additional relevant MeSH terms:
Tranquilizing Agents
Pathologic Processes
Disease
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2008




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