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

NCT00223210 | Completed Phase 4 DMC

• 1 other identifier: IRUSQUET 0397
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Cocaine Dependence

Keywords

bipolar disorder; cocaine dependence; quetiapine

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• To identify response versus non-response, logistic regression, assuming linearity, will be used.

  Study Exit

• We will utilize the urine drug screen repeatedly and cocaine use/cravings as the primary outcome measure.

  Study Exit

• 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

Study Arms (2)

Quetiapine

ACTIVE COMPARATOR

Drug: Quetiapine

Placebo

PLACEBO COMPARATOR

Inactive ingredient matching the active medication in appearance

Drug: PLacebo

Interventions

Quetiapine DRUG

Active Quetiapine

Also known as: Active Quetiapine

Quetiapine

PLacebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

The University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Cocaine-Related Disorders

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sherwood Brown, MD, PhD

  University of Texas, Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. E. Sherwood Brown, PhD

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: November 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: August 20, 2012

Record last verified: 2012-08

Locations

US (1)