Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00223249
Status:
COMPLETED
Last Update Posted:
2016-04-04
First Post:
2005-09-15
Brief Title:
Quetiapine in Patients With Bipolar and Alcohol AbuseDependence
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Add-On Trial of Quetiapine in Patients With Bipolar Disorder and Alcohol Abuse Dependence
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 abusedependence 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
Detailed Description:
Experimental After obtaining informed consent 100 patients with bipolar I or II disorders and alcohol abusedependence 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 drinks2 weeks days used in the past two weeks and days of heavy use will be obtained as will a urine drugalcohol 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 usecravings every 2 weeks at the end of the study or discontinuing medication
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None