Status:
UNKNOWN
Neurofunctional and Neurochemical Markers of Treatment Response in Bipolar Disorder
Lead Sponsor:
University of Cincinnati
Conditions:
Bipolar I Disorder
Eligibility:
All Genders
15-55 years
Phase:
PHASE4
Brief Summary
The purpose of the research is to study brain structure, function and chemistry of patients with bipolar disorder who are receiving lithium, an FDA-approved treatment for bipolar mania, in order to be...
Eligibility Criteria
Inclusion
- Inclusion Criteria- bipolar patients (Manic=, depressed=60; 30 patients/year):
- The patient meets DSM-IV criteria for type I bipolar disorder, manic or mixed, or depressed.
- The patient has an index Young Mania Rating Scale (YMRS)total score \>15 or Montgomery Asberg Rating Scale (MADRS) total score \>20.
- The patient is between 15 and 55 years old.
- Inclusion Criteria- Healthy subjects (N=40):
- Healthy subjects will be between the ages of 15 and 55 years.
- Healthy subjects will have no history of any Axis I psychiatric disorder.
- Healthy subjects will have no first-degree relatives with affective or psychotic disorders.
- Exclusion criteria: All subjects will be excluded from participation for the following reasons.
- 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 for any reason, including psychological impediments to being inside the MR scanner.
- The patient cannot attend follow-up visits.
Exclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2017
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00608075
Start Date
April 1 2007
End Date
July 1 2017
Last Update
October 6 2016
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0559