Pioglitazone and Quetiapine XR Pharmacogenetic Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01342380
Recruitment Status : Completed
First Posted : April 27, 2011
Last Update Posted : October 4, 2016
National Institutes of Health (NIH)
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Joseph Calabrese, MD, University Hospitals Cleveland Medical Center

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.

Condition or disease
Bipolar Disorder Major Depressive Disorder

Study Type : Observational
Actual Enrollment : 42 participants
Time Perspective: Retrospective
Official Title: Pharmacogenetic Study of Pioglitazone and Quetiapine XR Treatment Response in Mood Disorders
Study Start Date : February 2011
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Participants who received Seroquel
Participants who received pioglitazone

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01342380

United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Joseph Calabrese, MD
National Institutes of Health (NIH)
National Center for Research Resources (NCRR)
Principal Investigator: Jinbo Fan, PhD Case Western Reserve University

Responsible Party: Joseph Calabrese, MD, Director, Mood Disorders Program, University Hospitals Cleveland Medical Center Identifier: NCT01342380     History of Changes
Other Study ID Numbers: #10-10-25
First Posted: April 27, 2011    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Bipolar and Related Disorders
Quetiapine Fumarate
Hypoglycemic Agents
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs