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Pioglitazone and Quetiapine XR Pharmacogenetic Study

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Research Resources (NCRR)
Information provided by:
University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT01342380
First received: April 25, 2011
Last updated: April 26, 2011
Last verified: April 2011
History of Changes
  Purpose

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
Bipolar Disorder
Major Depressive Disorder

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Pharmacogenetic Study of Pioglitazone and Quetiapine XR Treatment Response in Mood Disorders

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • Genetic markers associated with treatment response [ Time Frame: Up to 1.5 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 310
Study Start Date: February 2011
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Seroquel
Participants who received Seroquel
Pioglitazone
Participants who received pioglitazone

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342380

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

No publications provided

Responsible Party: Jinbo Fan, PhD, Assistant Professor, Epidemiology & Biostatistics, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01342380     History of Changes
Other Study ID Numbers: #10-10-25
Study First Received: April 25, 2011
Last Updated: April 26, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bipolar Disorder
Depressive Disorder
Depression
Depressive Disorder, Major
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Pioglitazone
Quetiapine
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 18, 2013