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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223210
• Other study ID #: IRUSQUET 0397
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: August 16, 2012
• Start date: November 2005
• Est. completion date: December 2007

Study information

• Verified date: August 2012
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Drug:
• Quetiapine
Active Quetiapine
• PLacebo
Placebo

Locations

Country	Name	City	State
United States	The University of Texas 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	A random regression analysis will be done with treatment group as the between-subjects factor, time as the within-subjects factor, and a group by time interaction.		Study Exit	No
Primary	Within-group differences between pre- and post- treatment of the study drug will be compared using Wilcoxon rank sum tests, if the sample is not normally distributed between-group differences will be compared using the Mann-Whitney test.		Study Exit	No
Primary	To identify response versus non-response, logistic regression, assuming linearity, will be used.		Study Exit	No
Primary	We will utilize the urine drug screen repeatedly and cocaine use/cravings as the primary outcome measure.		Study Exit	No
Primary	Changes from base line to exit for all patients finishing at-least one follow up of active Quetiapine therapy, will be calculated, using the last observation carried forward (LOCF).		Study Exit	No