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Quetiapine for Bipolar Disorder and Alcohol Dependence
This study is currently recruiting participants.
Study NCT00457197   Information provided by University of Texas Southwestern Medical Center
First Received: April 4, 2007   Last Updated: August 4, 2009   History of Changes

April 4, 2007
August 4, 2009
March 2007
March 2012   (final data collection date for primary outcome measure)
The number of standard drinks/week will serve as the primary outcome measure. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The number of standard drinks/week will serve as the primary outcome measure.
Complete list of historical versions of study NCT00457197 on ClinicalTrials.gov Archive Site
Other measures of alcohol use including heavy drinking days and gamma-glutamyl transferase levels will serve as the secondary outcome measure. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Other measures of alcohol use including heavy drinking days and gamma-glutamyl transferase levels will serve as the secondary outcome measure.
 
Quetiapine for Bipolar Disorder and Alcohol Dependence
Quetiapine for Bipolar Disorder and Alcohol Dependence

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.

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.

Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
  • Bipolar Disorder
  • Alcohol Dependence
Drug: Quetiapine
Active Comparator: Quetiapine
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
120
 
March 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Amber Marchand, B.S., M.S. 214-645-6957 Amber.Marchand@utsouthwestern.edu
Contact: Jackie Todd, B.A. 214-645-6960 Jackie.Peterson@utsouthwestern.edu
United States
 
NCT00457197
E.S. Brown M.D., Ph.D., UT southwestern Medical Center at Dallas
112006-046
University of Texas Southwestern Medical Center
 
Principal Investigator: E. Sherwood Brown, MD PhD UT Southwestern Medical Center
University of Texas Southwestern Medical Center
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP