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Sleep Deprivation and Advancement of Sleep Period as Treatment for Bipolar Depression.

This study has been terminated.
(recruiting problems)
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00229151
First received: September 27, 2005
Last updated: April 6, 2012
Last verified: April 2012
History of Changes

September 27, 2005
April 6, 2012
October 2005
December 2011   (final data collection date for primary outcome measure)
Scores on rating scales for depression and symptom severity. [ Time Frame: one month ] [ Designated as safety issue: No ]
Scores on rating scales for depression and symptom severity.
Complete list of historical versions of study NCT00229151 on ClinicalTrials.gov Archive Site
Scores on rating scales for anxiety, mania, cognitive processing, and sleep quality. [ Time Frame: one month ] [ Designated as safety issue: No ]
Scores on rating scales for anxiety, mania, cognitive processing, and sleep quality.
Not Provided
Not Provided
 
Sleep Deprivation and Advancement of Sleep Period as Treatment for Bipolar Depression.
Sleep Deprivation and Three Days Sleep Phase Advancement as Treatment for Bipolar Depression.

The purpose of this study is to determine if sleep deprivation and sleep phase advancement is effective treatment of bipolar patients in a depressive phase.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Bipolar Disorder
  • 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.
  • 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
  • Experimental: Sleep deprivation
    Sleep deprivation and sleep phase advancement
    Intervention: Behavioral: Sleep deprivation and sleep phase advancement
  • Active Comparator: usual treatment
    Intervention: Other: usual treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Bipolar disorder, depressive phase

Exclusion Criteria:

  • substance abuse, psychotic symptoms, suicidal intentions, active mania/hypomania.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00229151
S2005.1.depr
No
Norwegian University of Science and Technology
Norwegian University of Science and Technology
Not Provided
Principal Investigator: Gunnar Morken, PhD MD Norwegian University of Science and Technology
Norwegian University of Science and Technology
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP