Pioglitazone and Quetiapine XR Pharmacogenetic Study

Pharmacogenetic Study of Pioglitazone and Quetiapine XR Treatment Response in Mood Disorders

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.

Study Overview

• Status: Completed
• Conditions: Bipolar Disorder; Major Depressive Disorder

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A total of 310 subjects between the ages of 18 and 70 will be targeted for enrollment. We anticipate a low enrollment rate of 200 from the targeted 310 participants. Eligible participants will be diagnosed with DSM-IV bipolar disorder (type I, II, or not otherwise specified) or DSM-IV major depressive disorder, as determined by extensive clinical interview and the Mini-International Neuropsychiatric Interview-Plus (MINI-Plus). Participants will be approached for enrollment if they are currently enrolled in one of four studies: IRB protocol numbers 10-06-19, 12-07-29, 07-07-20, and 07-08-24. Please see these protocols for additional study specific information.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Seroquel; Participants who received Seroquel
Pioglitazone; Participants who received pioglitazone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genetic markers associated with treatment response	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.	Up to 1.5 years

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: National Institutes of Health (NIH); National Center for Research Resources (NCRR)
• Investigators: Principal Investigator: Jinbo Fan, PhD, Case Western Reserve University

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: April 25, 2011
• First Submitted That Met QC Criteria: April 26, 2011
• First Posted (Estimated): April 27, 2011

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Bipolar and Related Disorders; Depressive Disorder; Bipolar Disorder; Depressive Disorder, Major
• Other Study ID Numbers: #10-10-25