Pilot Study of the Effects of Circadian Rhythms on the Treatment of Bipolar I Depression.
Withdrawn before enrolling · Not applicable
Conditions studied: Bipolar Disorder
In brief
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, including, sleep/wake rhythms, daily social routines (i.e., social rhythms), circadian type (morningness/eveningness), endogenous circadian rhythms and polymorphisms associated with altered circadian function in specific genes (namely, CLOCK, Period 2 and Period 3) moderate treatment response in bipolar disorder.
Key facts
- Study ID
- NCT00726154
- Run by
- University of Pittsburgh
- People needed
- 0
- Starts
- 2009-06-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2012-01-11
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Western Psychiatric Institute and Clinic — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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