Quetiapine in Patients With Bipolar and Alcohol Abuse/Dependence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00223249
First received: September 15, 2005
Last updated: July 31, 2012
Last verified: January 2010

September 15, 2005
July 31, 2012
November 2002
August 2004   (final data collection date for primary outcome measure)
Number of Standard Drinks [ Time Frame: Weekly ]
Not Provided
Complete list of historical versions of study NCT00223249 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Quetiapine in Patients With Bipolar and Alcohol Abuse/Dependence
A Randomized, Double-Blind, Placebo-Controlled Add-On Trial of Quetiapine in Patients With Bipolar Disorder and Alcohol Abuse/ Dependence.

The abuse of alcohol is especially common in people with bipolar disorder. However, very little is known about the pharmacotherapy of people with both bipolar disorder and alcohol abuse/dependence. The purpose of this study is to determine if alcohol use and cravings are decreased with quetiapine add-on therapy compared to placebo and to determine if quetiapine add-on therapy is associated with greater improvement in mood, impulsivity, functioning and decreased alcohol use than placebo.

Experimental: After obtaining informed consent, 100 patients with bipolar I, or II disorders and alcohol abuse/dependence confirmed by a structured clinical interview (SCID) will be enrolled. from referral sources in the community we have developed over the past 3 years. A medical history and physical examination, including an eye exam with an ophthalmoscope, will also be performed at baseline to rule out serious medical illnesses and cataracts. Baseline labs including a liver panel and CBC will be obtained. Women of child-bearing potential will be given a urine pregnancy test. Baseline measures of psychiatric symptoms will be assessed with the HRSD, YMRS, and Barratt Impulsiveness Scale. Alcohol cravings will be assessed with the Obsessive Compulsive Drinking Scale (OCDS). Alcohol use including number of drinks/2 weeks, days used in the past two weeks, and days of heavy use will be obtained as will a urine drug/alcohol screen. Alcohol use and cravings will also be recorded throughout the study. Side-effects will be assessed with a general side effects scale, the Abnormal Involuntary Movement Scale (AIMS), Simpson-Angus Scale (SAS), and Barnes Akathesia Rating Scale (BARS). GGT levels will also be repeated at weeks 6 and 12. The subjects will be randomized and receive quetiapine or identical appearing placebo add-on therapy in a double-blind fashion for 12 weeks. Subjects will return every two weeks for reevaluation with the above outcome measures and for upward titration of study drug. All subjects will be given the option of receiving open-label quetiapine for an additional 4 weeks (with continuing assessment of mood and alcohol use/cravings every 2 weeks) at the end of the study or discontinuing medication.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Bipolar Disorder
  • Alcohol Abuse/Dependence
Drug: Quetiapine
  • Active Comparator: Quetiapine
    Quetiapine
    Intervention: Drug: Quetiapine
  • Placebo Comparator: Placebo
    Inactive ingredient matching the active medication in appearance
Brown ES, Garza M, Carmody TJ. A randomized, double-blind, placebo-controlled add-on trial of quetiapine in outpatients with bipolar disorder and alcohol use disorders. J Clin Psychiatry. 2008 May;69(5):701-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
August 2004
August 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Bipolar I or II
  • Ages 18-70

Exclusion Criteria:

  • Life threatening medical condition causing participation in the study hazardous
  • Alcohol abuse within the past 2 weeks
  • History of cataracts or likely cataracts on baseline eye exam
  • History of hepatic cirrhosis or AST or ALT more than three times normal limit
  • Current active suicidal or homicidal ideation
  • History of allergic reaction, poor response or intolerable side effects to quetiapine
  • Antipsychotic use within 7 days of beginning quetiapine therapy
  • Mental retardation, dementia or other severe cognitive impairment
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00223249
IRUSQUET0233
No
University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Not Provided
Principal Investigator: E. Sherwood Brown, Ph.D., M.D. The UT Southwestern Medical Center at Dallas
University of Texas Southwestern Medical Center
January 2010

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