"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?"

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 disorders for many years. During the last 4 years we have performed and been involved in several light therapy studies in depression, both in seasonal affective disorder (SAD), with light as an augmentation strategy in nonseasonal depression, in post-stroke depression and in Tourette's syndrome.

In relation to the dissemination of results from Klaus Martiny's Ph.D. thesis on bright light therapy as an augmenting strategy in major depression, our research unit has achieved close collaboration with some of the world's leading experts in chronotherapeutics: Professor Anna Wirz-Justice in Basel, Switzerland, Franscesco Benedetti in Milano, Italy, Michael Terman in New York, Mathias Berger in Freiburg, Germany and Joseph Wu at the University of California, Irvine. The basic idea of the present study comes from this group which over many years has performed and reported clinical studies in chronotherapeutics. We hope that our research unit will be able to conduct this study, as required, in a large patient sample and under the guidance of this group.

The study will fulfill the research unit's ambition to investigate antidepressive treatment algorithms with the propensity to lead to an earlier and sustained onset of action and a higher remission rate. Remission from depression does not only restore the patients' normal social functioning, but also reduces the risk of recurrence of depression. To attain this goal we regard the combination of new and powerful antidepressive drugs and non-pharmacological therapies most interesting and promising. This study has full support from the hospital administration who welcomes the active involvement of the nursing staff in the chronotherapeutic part.