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

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ClinicalTrials.gov Identifier: NCT00229151
Recruitment Status : Terminated (recruiting problems)
First Posted : September 29, 2005
Last Update Posted : April 9, 2012
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Behavioral: Sleep deprivation and sleep phase advancement Other: usual treatment Not Applicable

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Scores on rating scales for depression and symptom severity. [ Time Frame: one month ]

Secondary Outcome Measures :
  1. Scores on rating scales for anxiety, mania, cognitive processing, and sleep quality. [ Time Frame: one month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Bipolar disorder, depressive phase

Exclusion Criteria:

  • substance abuse, psychotic symptoms, suicidal intentions, active mania/hypomania.
Contacts and Locations
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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


Locations
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Norway
Norwegian University of Science and Technology, Institute of Neuroscience
Trondheim, Norway, 7489
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
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Principal Investigator: Gunnar Morken, PhD MD Norwegian University of Science and Technology
More Information
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00229151     History of Changes
Other Study ID Numbers: S2005.1.depr
First Posted: September 29, 2005    Key Record Dates
Last Update Posted: April 9, 2012
Last Verified: April 2012
Additional relevant MeSH terms:
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Sleep Deprivation
Depression
Bipolar Disorder
Behavioral Symptoms
Bipolar and Related Disorders
Mental Disorders
 Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms