An Add-On Trial of Quetiapine in Patients With Bipolar Disorder and Cocaine Dependence

NCT ID: NCT00223210

Last Updated: 2012-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2007-12-31

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 abuse/dependence, 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 spent/week and days used/week) 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 mg/day with additional flexible titration after that time to a maximum of 800 mg/day 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.

Conditions

Bipolar Disorder; Cocaine Dependence

Keywords

bipolar disorder; cocaine dependence; quetiapine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Quetiapine

Group Type: ACTIVE_COMPARATOR

Quetiapine

Intervention Type: DRUG

Active Quetiapine

Placebo

Inactive ingredient matching the active medication in appearance

Group Type: PLACEBO_COMPARATOR

PLacebo

Intervention Type: DRUG

Placebo

Interventions

Quetiapine

Active Quetiapine

Intervention Type: DRUG

PLacebo

Placebo

Intervention Type: DRUG

Other Intervention Names

Active Quetiapine

Eligibility Criteria

Inclusion Criteria

• Bipolar Disorder, type I; Cocaine Dependence with use in the past 7 days; Currently taking a mood stabilizer; Meets criteria for a hypomanic or manic episode

Exclusion Criteria

• Bipolar Disorder, type II, NOS; Cyclothymia; Other substance dependence; Diabetes; Initiated therapy in the past 2 weeks; History of cataracts or likely cataracts; Current active suicidal or homicidal ideation; Life threatening medical condition; Mental retardation, dementia or severe cognitive impairment; Pregnant or nursing womenon; antipsychotic within 7 days of beginning Quetiapine therapy or have initiated antidepressants or mood stabilizers or psychotherapy within the past two weeks.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sherwood Brown

Dr. E. Sherwood Brown, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sherwood Brown, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas, Southwestern Medical Center at Dallas

Locations

The University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Countries

United States

Other Identifiers

IRUSQUET 0397

Identifier Type: -

Identifier Source: org_study_id