Pioglitazone and Quetiapine XR Pharmacogenetic Study

NCT ID: NCT01342380

Last Updated: 2023-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bipolar Disorder Major Depressive Disorder

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Seroquel

Participants who received Seroquel

No interventions assigned to this group

Pioglitazone

Participants who received pioglitazone

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jinbo Fan, PhD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

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University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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#10-10-25

Identifier Type: -

Identifier Source: org_study_id

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