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Sponsors and Collaborators: |
University of Cincinnati National Institutes of Health (NIH) |
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Information provided by: | University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT00608296 |
The purpose of the research is to study brain structure, function and chemistry of patients with bipolar disorder who are receiving quetiapine or lithium, in order to better understand who benefits from treatment and why they respond to medications.
Condition |
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Bipolar |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Functional and Neurochemical Brain Changes Following Successful Treatment of Early Course Bipolar Depression |
Estimated Enrollment: | 120 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | July 2013 |
Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Study subjects on lithium
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2
study subjects on quetiapine
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Ages Eligible for Study: | 15 Years to 35 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
You are being asked to take part in this research study because you have been diagnosed with bipolar disorder and are currently experiencing a depressive episode. Bipolar disorder is an illness characterized by recurrent mood swings including mania, (periods of elation, excessive excitement, irritability, high energy, racing thoughts, poor sleep, poor judgment, reckless behavior) and clinical depression (periods of depressed mood, loss of interest in activities and disruption of sleep, appetite and energy). To participate in this study you must be at least 16 years old, and no older than 35.
Inclusion Criteria - Depressed bipolar patients (N=80; 15-20 patients/year):
Exclusion criteria: All subjects will be excluded from participation for the following reasons:
Contact: Jonathan Schroer, BA, BPhil | 513-558-3991 | jonathan.schroer@uc.edu |
United States, Ohio | |
University of Cincinnati | Recruiting |
Cincinnati, Ohio, United States, 45267-0559 |
Principal Investigator: | Caleb M Adler, MD | University of Cincinnati |
Responsible Party: | University of Cincinnati ( Caleb M. Adler, MD ) |
Study ID Numbers: | BITREC - Project II |
Study First Received: | January 23, 2008 |
Last Updated: | February 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00608296 History of Changes |
Health Authority: | United States: Institutional Review Board |
Affective Disorders, Psychotic Depression Mental Disorders Bipolar Disorder |
Mood Disorders Psychotic Disorders Depressive Disorder Behavioral Symptoms |
Affective Disorders, Psychotic Depression Mental Disorders |
Bipolar Disorder Mood Disorders Behavioral Symptoms |