View Clinical Trial (Medical Research Study)
Functional and Neurochemical Brain Changes in First-episode Bipolar Mania Following Successful Treatment With Lithium or Quetiapine
| City: |
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Cincinnati |
| State: |
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Ohio |
| Zip Code: |
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45267 |
| Conditions: |
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Bipolar |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria - First-episode manic bipolar patients (N=100; 15-20 patients/year):
1. Patients meet DSM-IV criteria for type I bipolar disorder, manic or mixed.
2. Patients have an index Young Mania Rating Scale (YMRS)70 total score >20.
3. 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.
4. Patients have no more than two prior episodes of major depression.
5. 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.
1. Any chemical use disorder within 3 months.
2. Any medical or neurological disorder that could influence fMRI and MRS results.
3. A history of mental retardation or an estimated IQ total score <85.
4. An MRI scan is contraindicated in the subject.
5. The patient cannot attend follow-up visits.
6. A positive urine pregnancy test (in women).
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| NCT ID: |
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NCT00609193 |
| Primary Contact: |
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Principal Investigator
Stephen M Strakowski, MD
University of Cincinnati
DeAnna Owens, BA
Phone: 513-558-1193
Email: owensd2@uc.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Cincinnati, Ohio 45267
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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