Status:
COMPLETED
Functional and Neurochemical Brain Changes Bipolar Depression
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Depression, Bipolar
Eligibility:
All Genders
12-35 years
Brief Summary
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 fr...
Eligibility Criteria
Inclusion
- Inclusion Criteria - Depressed bipolar patients (N=100; 15-20 patients/year):
- Patients will meet DSM-IV criteria for type I bipolar disorder, depressed, as determined by structured interview and best-estimate diagnostic procedures.138
- Patient has experienced a maximum of three documented affective episodes.
- Patient has been off medications for one week prior to study enrollment.
- Patient has a Hamilton Depression Rating Scale (HDRS) total score ≥20
- Patient is between the ages of 12 and 35 years.
- Exclusion criteria: All subjects will be excluded from participation for the following reasons:
- Any chemical use disorder within 3 months.
- Any history of significant suicidality that would place the patient at risk to participate in this protocol.
- Current score ≥3 on item 3 of the HDRS-17 (Suicide Item)
- Any medical or neurological disorder that could influence fMRI results.
- A history of mental retardation or an estimated IQ total score \<85.
- An MRI scan is contraindicated in the subject for any reason.
- The patient lives \>100 miles from the University of Cincinnati or cannot attend follow-up visits.
- Meets DSM-IV criteria for a bipolar mixed episode
Exclusion
Key Trial Info
Start Date :
January 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2013
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00608296
Start Date
January 1 2008
End Date
July 1 2013
Last Update
December 23 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0559