drugset / Trial / NCT00149110
Chronos: the Use of Chronobiological Treatment in Depression
Completed
75 enrolled
Hillerod Hospital, Denmark
Eli Lilly and Company · collabThe County of Frederiksborg · collab
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2005-09
- Primary completion
- 2009-03
- Completion
- 2009-03
Publications
- Background 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. doi: 10.1017/s003329170500437x.
- Martiny K, Refsgaard E, Lund V, Lunde M, Sorensen L, Thougaard B, Lindberg L, Bech P. The day-to-day acute effect of wake therapy in patients with major depression using the HAM-D6 as primary outcome measure: results from a randomised controlled trial. PLoS One. 2013 Jun 28;8(6):e67264. doi: 10.1371/journal.pone.0067264. Print 2013.
- Martiny K, Refsgaard E, Lund V, Lunde M, Sorensen L, Thougaard B, Lindberg L, Bech P. A 9-week randomized trial comparing a chronotherapeutic intervention (wake and light therapy) to exercise in major depressive disorder patients treated with duloxetine. J Clin Psychiatry. 2012 Sep;73(9):1234-42. doi: 10.4088/JCP.11m07625.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Duloxetine | Small molecule | 60 mg | — |