Status:
COMPLETED
Chronos: the Use of Chronobiological Treatment in Depression
Lead Sponsor:
Hillerod Hospital, Denmark
Collaborating Sponsors:
Eli Lilly and Company
The County of Frederiksborg
Conditions:
Major Depression
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The primary objective of the present study is to examine whether the combination of the antidepressant duloxetine and chronotherapeutic methods (including sleep deprivation, light therapy, and maintai...
Detailed Description
Protocol synopsis Background: The Psychiatric Research Unit at Frederiksborg General Hospital, with professor Per Bech as the driving force, has been working with sleep in relation to affective diso...
Eligibility Criteria
Inclusion
- A diagnosis of major depression according to DSM-IV
- Patient with major depression as part of a bipolar disorder should be in adequate mood stabilizing therapy at entry to the study
- Age of 18 or above
- A score on the Hamilton Depression Scale, 17 items version of at least 18
Exclusion
- Primary psychotic disorder
- Psychotic depression
- Drug or alcohol abuse
- Severe organic brain disease
- Severe suicidal ideation (a score of 2 or above on the Hamilton Depression Scale, 17-items version)
- Mental retardation
- Pregnancy or lactation period
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00149110
Start Date
September 1 2005
End Date
March 1 2009
Last Update
August 6 2009
Active Locations (1)
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1
Psychiatric Research Unit, Hilleroed Hospital
Hilleroed, Denmark, 3400