Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00223210
Status:
COMPLETED
Last Update Posted:
2012-08-20
First Post:
2005-09-14
Brief Title:
An Add-On Trial of Quetiapine in Patients With Bipolar Disorder and Cocaine Dependence
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 Cocaine Dependence
Status:
COMPLETED
Status Verified Date:
2012-08
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 purpose of this study is to determine if quetiapine add-on therapy is associated with a decrease in cocaine use and craving and a greater improvement in mood
Detailed Description:
One Hundred 100 outpatients with a diagnosis of bipolar I disorder and cocaine abusedependence established by a structured clinical interview and confirmed by a psychiatrist will participate Eligible participants will be given a physical exam including an eye exam with an ophthalmoscope to rule out serious medical illnesses and cataracts Additionally medical and psychiatric histories and baseline labs including CBC and a liver panel will be obtained Blood will be drawn for routine laboratory analyses including a complete blood count CBC and SMA-20 at baseline and exit Women of childbearing potential will be given a urine pregnancy test Baseline measures of psychiatric symptoms will be assessed with the Hamilton Rating Scale for Depression HRSD Young Mania Rating Scale YMRS Inventory of Depression Symptomatology-Self-Report 30-item version IDS-SR30 and the Psychobiology of Recovery in Depression III - Somatic Symptom Scale PRD-III Cocaine craving will be assessed with Cocaine Craving Questionnaire CCQ Drug use will be assessed by self-report with the Addiction Severity Index ASI and a urine drug screen UDS Two UDSs are performed at baseline Cocaine use in the past week dollar amount spentweek and days usedweek will be assessed by patient self-report Use of and craving for other substances benzodiazepines barbiturates alcohol opiates phencyclidine and cannabis will also be assessed by self-report of dollar amount and days used in the past week UDSs and with 100-mm single item visual analog craving scales Side effects will be assessed with the Abnormal Involuntary Movement Scale AIMS the Simpson-Angus Scale SAS and the Barnes Akathesia Rating Scale BARS Subjects will be randomized and be titrated up to 400 mgday with additional flexible titration after that time to a maximum of 800 mgday of Quetiapine or identical appearing placebo add-on therapy in a double- blind fashion for 12 weeks At each weekly assessment subjects will be evaluated with the HRSD17 IDS-R30 YMRS CCQ and a UDS and receive an upward titration of the study drug The ASI will be repeated every four weeks Further participants will return one additional time each week for a UDS At the end of the study an unblinded psychiatrist will provide standard open label treatment with Quetiapine until the participants can be transferred back to their usual treatment facility Follow up and after care arrangements will be made for each participant near completion of the study
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