Quetiapine in Patients With Bipolar and Alcohol Abuse/Dependence

Bipolar Disorder Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Add-On Trial of Quetiapine in Patients With Bipolar Disorder and Alcohol Abuse/ Dependence.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223249
• Other study ID #: IRUSQUET0233
• Status: Completed
• Phase: Phase 4
• First received: September 15, 2005
• Last updated: April 1, 2016
• Start date: November 2002
• Est. completion date: August 2004

Study information

• Verified date: April 2016
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: August 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Abuse/Dependence
• Alcoholism
• Bipolar Disorder

Intervention

Drug:
• Quetiapine

Locations

Country	Name	City	State
United States	The UT Southwestern Medical Center at Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Standard Drinks		Weekly