Major Depression Clinical Trial
Official title:
"The CHRONOS Study: Can the Sleep-deprivation Induced Antidepressive Effect in Patients With Major Depression be Sustained by Correction of Diurnal Rhythms, Long Term Light Treatment and Duloxetine Treatment?"
Verified date | August 2009 |
Source | Hillerod Hospital, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Medicines Agency |
Study type | Interventional |
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 maintaining a regular sleep-wake rhythm) in patient with major depression, will induce an immediate improvement from depression and whether this antidepressive effect will be maintained in the long term (29 weeks). Patient will be randomised to the above mentioned treatment or to an active group receiving exercise.
Status | Completed |
Enrollment | 75 |
Est. completion date | March 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Psychiatric Research Unit, Hilleroed Hospital | Hilleroed |
Lead Sponsor | Collaborator |
---|---|
Hillerod Hospital, Denmark | Eli Lilly and Company, The County of Frederiksborg |
Denmark,
Wirz-Justice A, Benedetti F, Berger M, Lam RW, Martiny K, Terman M, Wu JC. Chronotherapeutics (light and wake therapy) in affective disorders. Psychol Med. 2005 Jul;35(7):939-44. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hamilton score during the 29 weeks trial | 1 week | No | |
Secondary | Cortisol measurements | 1 week | No | |
Secondary | Depression self rating by the Preskorn scale | 9 month | No |
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