Pioglitazone and Quetiapine XR Pharmacogenetic Study

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01342380
• Other study ID #: #10-10-25
• Status: Completed
• Start date: February 2011
• Est. completion date: May 2015

Study information

• Verified date: July 2023
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	National Center for Research Resources (NCRR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

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