Status:
WITHDRAWN
Pilot Study of the Effects of Circadian Rhythms on the Treatment of Bipolar I Depression.
Lead Sponsor:
University of Pittsburgh
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The objective of this pilot study is to test the feasibility of a larger planned trial. The objective of this larger trial will be to determine the extent to which aspects of circadian rhythmicity, in...
Detailed Description
This study is a small scale pilot study which will be used to support a larger trial. The major aims of the larger study are to determine the extent to which aspects of circadian rhythmicity, includin...
Eligibility Criteria
Inclusion
- Age 18 to 60 years
- Able to give basic informed consent
- Meets DSM-IV criteria for current acute episode of bipolar I depression
- Women of childbearing potential must agree to use a doctor-approved birth control throughout participation in the study
- Hamilton Depression Rating Scale (17-item) score \> or equal to 15
- Hamilton Depression Rating Scale (17-item) item 1 score \> or equal to 2
- Young Mania Rating Scale score \< or equal to 12
Exclusion
- Unwilling or unable to comply with study requirements (i.e., complete forms, attend scheduled evaluations)
- Not competent to provide informed consent in the opinion of the investigator
- Rapid cycling (4 or more episodes per year) bipolar I disorder
- Present treatment for index depressive episode with lithium or quetiapine unless does or serum level are deemed inadequate
- Lithium intolerance or a past failed adequate trial of Lithium
- Quetiapine intolerance or a past failed adequate trial of quetiapine
- Presence of schizophrenia, schizoaffective, antisocial or pervasive developmental disorder, psychotic disorder, current substance dependence, and organic mental disorder
- Axis II borderline disorder
- Mini-Mental State Examination score \<24
- Current alcohol and illicit substance abuse
- Women who are currently pregnant, planning to become pregnant or currently breast-feeding
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00726154
Start Date
June 1 2009
End Date
June 1 2009
Last Update
January 11 2012
Active Locations (1)
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1
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213