- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00223249
Quetiapine in Patients With Bipolar and Alcohol Abuse/Dependence
April 1, 2016 updated by: University of Texas Southwestern Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
115
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Dallas, Texas, United States, 75390-8843
- The UT Southwestern Medical Center at Dallas
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Inactive ingredient matching the active medication in appearance
|
|
Active Comparator: Quetiapine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Standard Drinks
Time Frame: Weekly
|
Weekly
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: E. Sherwood Brown, Ph.D., M.D., The UT Southwestern Medical Center at Dallas
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2002
Primary Completion (Actual)
August 1, 2004
Study Completion (Actual)
August 1, 2004
Study Registration Dates
First Submitted
September 15, 2005
First Submitted That Met QC Criteria
September 15, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
April 4, 2016
Last Update Submitted That Met QC Criteria
April 1, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Alcohol-Related Disorders
- Substance-Related Disorders
- Bipolar and Related Disorders
- Alcoholism
- Bipolar Disorder
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- Quetiapine Fumarate
Other Study ID Numbers
- IRUSQUET0233
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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