Chronos: the Use of Chronobiological Treatment in Depression

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hillerod Hospital, Denmark
• Collaborators: Eli Lilly and Company; The County of Frederiksborg
• Treatments: Duloxetine Hydrochloride

Criteria

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