Pioglitazone and Quetiapine XR Pharmacogenetic Study

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Depressive Disorder Depressive Disorder, Major Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Genetic markers associated with treatment response

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

National Center for Research Resources (NCRR)
National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Apr 27, 2011
Registry last updated: Jul 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed