Sleep Deprivation and Advancement of Sleep Period as Treatment for Bipolar Depression.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00229151|
Recruitment Status : Terminated (recruiting problems)
First Posted : September 29, 2005
Last Update Posted : April 9, 2012
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Behavioral: Sleep deprivation and sleep phase advancement Other: usual treatment||Not Applicable|
Background: The onset of therapeutic action for most anti-depressive treatments is usually two weeks. During this period patients suffer from great symptomatic distress. Treatment options that are effective in this period is therefore of interest for psychiatric wards.
Aim: To explore if sleep deprivation and three days sleep phase advancement is effective treatment for inpatients with bipolar disorder in a depressive phase.
Method: A randomized controlled trial with 24 patients diagnosed with bipolar disorder. Patients will be randomized to treatment as usual in an psychiatric ward, or sleep deprivation and three days sleep phase advancement. Patients in the treatment as usual group will be offered treatment with sleep deprivation and sleep phase advancement after five weeks if they still meet inclusion criteria.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sleep Deprivation and Three Days Sleep Phase Advancement as Treatment for Bipolar Depression.|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Experimental: Sleep deprivation
Sleep deprivation and sleep phase advancement
Behavioral: Sleep deprivation and sleep phase advancement
Total sleep deprivation from 0800 to 1700 next day, and three day sleep phase advancement following sleep deprivation.
|Active Comparator: usual treatment||
Other: usual treatment
Treatment as usual in the psychiatric ward. Patients in this group will be offered treatment with sleep deprivation and sleep phase advancement after five weeks if they still meet inclusion criteria
- Scores on rating scales for depression and symptom severity. [ Time Frame: one month ]
- Scores on rating scales for anxiety, mania, cognitive processing, and sleep quality. [ Time Frame: one month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00229151
|Norwegian University of Science and Technology, Institute of Neuroscience|
|Trondheim, Norway, 7489|
|Principal Investigator:||Gunnar Morken, PhD MD||Norwegian University of Science and Technology|