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Pioglitazone and Quetiapine XR Pharmacogenetic Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01342380
Enrollment
42
Registered
2011-04-27
Start date
2011-02-28
Completion date
2015-05-31
Last updated
2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Major Depressive Disorder

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.

Interventions

None listed

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Center for Research Resources (NCRR)
CollaboratorNIH
University Hospitals Cleveland Medical Center
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Genetic markers associated with treatment responseUp to 1.5 yearsGenetic 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026