Major Depressive Disorder Clinical Trial
Official title:
Pharmacogenetic Study of Pioglitazone and Quetiapine XR Treatment Response in Mood Disorders
NCT number | NCT01342380 |
Other study ID # | #10-10-25 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 2011 |
Est. completion date | May 2015 |
Verified date | July 2023 |
Source | University Hospitals Cleveland Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 42 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Cleveland Medical Center | National Center for Research Resources (NCRR), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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