|
|
|
|
|
|
Sponsored by: |
University of Cincinnati |
Information provided by: | University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT00609193 |
The purpose of this study is to use magnetic resonance imaging (MRI) to examine brain structure, function and chemistry in people with bipolar disorder who are being treated with either quetiapine or lithium. Both of these medicines are FDA-approved to treat mania in adults and lithium is also FDA approved in children; quetiapine is commonly used in children with mania, but is not FDA approved for this indication in this age group.
Condition | Intervention | Phase |
Bipolar |
Drug: lithium Drug: quetiapine |
Phase IV |
MedlinePlus related topics: | Bipolar Disorder MRI Scans |
Drug Information available for: | Quetiapine Quetiapine fumarate Lithium carbonate Lithium citrate |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
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 | Assigned Interventions |
1
Study subjects receiving lithium
|
Drug: lithium
standard clinical care
|
2
Study subjects receiving quetiapine
|
Drug: quetiapine
standard clinical care
|
3
Healthy controls
|
Ages Eligible for Study: | 16 Years to 35 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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 mania. Mania is identified by periods of extreme elation or irritability, excessive energy, racing thoughts, difficulty sleeping, poor judgment and/or reckless behavior. Bipolar disorder is an illness in which people experience mania as well as mood swings into depression. To participate in this study you must be at least 16 years old and no older than 35.
Inclusion Criteria - First-episode manic bipolar patients (N=80; 15-20 patients/year):
Inclusion Criteria - Healthy subjects (N=40; 8-10 subjects/year):
Exclusion criteria: All subjects will be excluded from participation for the following reasons.
Contact: Jonathon Schroer, BA, BPh | 513-558-3991 | jonathon.schroer@uc.edu |
United States, Ohio | |||||
University of Cincinnati | Recruiting | ||||
Cincinnati, Ohio, United States, 45267-0559 |
University of Cincinnati |
Principal Investigator: | Stephen M Strakowski, MD | University of Cincinnati |
Responsible Party: | University of Cincinnati ( Stephen M. Strakowski, MD ) |
Study ID Numbers: | BITREC - Project I |
First Received: | January 23, 2008 |
Last Updated: | July 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00609193 |
Health Authority: | United States: Institutional Review Board |
|
|
|