Pioglitazone and Quetiapine XR Pharmacogenetic Study

Completed

• Conditions: Major Depressive Disorder; Bipolar Disorder

• Registration Number: NCT01342380
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary

Obtain phenotypic data and a DNA/blood sample from mood disorder patients undergoing pioglitazone or quetiapine XR treatment as a part of an IRB approved clinical trial conducted at the Mood Disorders Program. Pioglitazone treatment is examined in metabolic syndrome comorbid with bipolar depression (IRB # 07-08-24) and unipolar depression (IRB # 07-07-20). Quetiapine XR treatment is examined in generalized anxiety disorder comorbid with bipolar depression (IRB # 10-06-19) and unipolar depression (IRB # 12-01-29). Please refer to the respective IRB protocols for more information.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-04-25
• Study First Submitted QC: 2011-04-26
• Study First Posted: 2011-04-27
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-14
• Last Update Posted: 2023-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Must have participated in IRB protocols 10-06-19, 12-07-29, 07-07-20, and 07-08-24
• Patient must give consent to participate, sign and date the IRB approved written informed consent form prior to the initiation of any procedures for this study
• Patient must be diagnosed with Bipolar Disorder or Major Depressive Disorder
• Patient must be at least 18 years old
• Patient must be willing to give a blood sample

Exclusion Criteria

• Patient lacks the capacity to provide informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Genetic markers associated with treatment response	Up to 1.5 years	Genetic markers in PPARG, 5-HT2A, CYP3A4 and CYP2C8 genes known to be related in the pharmacodynamics and pharmacokinetics of pioglitazone or quetiapine XR will be associated with treatment response.

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States