Viewing Study NCT00227123



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Last Modification Date: 2024-10-26 @ 9:19 AM
Study NCT ID: NCT00227123
Status: COMPLETED
Last Update Posted: 2008-01-04
First Post: 2005-09-23

Brief Title: A Randomized Control Trial Comparing Quetiapine to Risperidone in Bipolar Disorder With Stimulant Dependence
Sponsor: University of Texas Southwestern Medical Center
Organization: University of Texas Southwestern Medical Center

Study Overview

Official Title: A Randomized Control Trial Comparing Quetiapine to Risperidone in Bipolar Disorder Outpatients With Current Stimulant Dependence
Status: COMPLETED
Status Verified Date: 2007-10
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 whether quetiapine or risperidone are effective in treating mood symptoms drug cravings and use in bipolar disorder with concurrent cocaine or methamphetamine dependence
Detailed Description: Bipolar disorder may be associated with the highest rates of substance abuse of any psychiatric illness Studies suggest that substance abuse in persons with bipolar disorder have lifetime prevalence rates as high as 60 with reports of cocaine abuse as high as 30 Comorbid substance abuse in persons with bipolar disorder is associated with increased hospitalization poorer psychiatric recovery and treatment response than in patients with bipolar disorder alone Thus therapeutic agents that may enhance prognosis by improving psychiatric outcomes reducing stimulant cravings and increasing treatment retention are of considerable interest In a previous study conducted in this lab we found that conventional neuroleptic agents were associated with an increase in depressive symptoms and a significant increase in stimulant cravings These results mirror preclinical animal data that show conventional neuroleptics iehaloperidol with high dopamine receptor binding affinities actually increase cocaine self-administration in rats and monkeys These results are clinically relevant as persons with bipolar disorder who abuse cocaine and other drugs often receive higher doses of conventional neuroleptics than those without cocaine or other drug abuse In contrast to conventional neuroleptic therapy atypical antipsychotics ie quetiapine risperidone decrease self-administration of cocaine The receptor binding profile of the atypical antipsychotics broadly vary although all agents in this drug class are known as serotonin-dopamine antagonists Quetiapine has moderate dopamine binding while risperidone has high dopamine receptor binding properties similar to conventional neuroleptic agents Thus our hypothesis is that quetiapine may be a more efficacious agent than risperidone in treating bipolar mood symptoms while attenuating drug cravings and use

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
Secondary IDs
Secondary ID Type Domain Link
02T147 None None None