Status:
COMPLETED
Functional and Neurochemical Brain Changes in First-episode Bipolar Mania
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Bipolar Disorder
Eligibility:
All Genders
12-35 years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria - First-episode manic bipolar patients (N=100; 15-20 patients/year):
- Patients meet DSM-IV criteria for type I bipolar disorder, manic or mixed.
- Patients have an index Young Mania Rating Scale (YMRS)70 total score \>20.
- Patients have \<3 months of lifetime anti-manic or anti-depressant medication exposure, including no active psychotropic medication in the one weeks prior to the index admission. Importantly, patients will NOT be taken off medications for this study; this criterion is to exclude subjects receiving active treatment at the time of admission to support the 'first-episode' criterion.
- Patients have no more than two prior episodes of major depression.
- Patients are between 12 and 35 years old; subjects \< 18 yrs old have a Tanner greater than or equal to 4
- Exclusion criteria: All subjects will be excluded from participation for the following reasons.
- Any chemical use disorder within 3 months.
- Any medical or neurological disorder that could influence fMRI and MRS results.
- A history of mental retardation or an estimated IQ total score \<85.
- An MRI scan is contraindicated in the subject.
- The patient cannot attend follow-up visits.
- A positive urine pregnancy test (in women).
Exclusion
Key Trial Info
Start Date :
January 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00609193
Start Date
January 1 2008
End Date
July 1 2015
Last Update
December 7 2015
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0559