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
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Alcohol Abuse/Dependence
Drug: Quetiapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Add-On Trial of Quetiapine in Patients With Bipolar Disorder and Alcohol Abuse/ Dependence.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Standard Drinks [ Time Frame: Weekly ]

Enrollment: 115
Study Start Date: November 2002
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Quetiapine
Quetiapine
Drug: Quetiapine
Placebo Comparator: Placebo
Inactive ingredient matching the active medication in appearance

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223249

Locations
United States, Texas
The UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-8843
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: E. Sherwood Brown, Ph.D., M.D. The UT Southwestern Medical Center at Dallas
  More Information

No publications provided by University of Texas Southwestern Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00223249     History of Changes
Other Study ID Numbers: IRUSQUET0233
Study First Received: September 15, 2005
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bipolar Disorder
Alcoholism
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 29, 2014