Pioglitazone and Quetiapine XR Pharmacogenetic Study

NCT01342380 | Completed DMC

• 1 other identifier: #10-10-25
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Seroquel

Participants who received Seroquel

Pioglitazone

Participants who received pioglitazone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patient lacks the capacity to provide informed consent

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• National Institutes of Health (NIH): collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Depressive Disorder

Study Officials

• Jinbo Fan, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2011
• First Posted: April 27, 2011
• Study Start: February 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 18, 2023

Record last verified: 2023-07

Locations

US (1)