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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
  Purpose

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 Intervention
Bipolar Disorder
Behavioral: Sleep deprivation and sleep phase advancement
Other: usual treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sleep Deprivation and Three Days Sleep Phase Advancement as Treatment for Bipolar Depression.

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Scores on rating scales for depression and symptom severity. [ Time Frame: one month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Scores on rating scales for anxiety, mania, cognitive processing, and sleep quality. [ Time Frame: one month ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: October 2005
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00229151

Locations
Norway
Norwegian University of Science and Technology, Institute of Neuroscience
Trondheim, Norway, 7489
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Gunnar Morken, PhD MD Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00229151     History of Changes
Other Study ID Numbers: S2005.1.depr
Study First Received: September 27, 2005
Last Updated: April 6, 2012
Health Authority: Norway: Norwegian Social Science Data Services

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Sleep Deprivation
Affective Disorders, Psychotic
Behavioral Symptoms
Dyssomnias
Mental Disorders
Mood Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Sleep Disorders

ClinicalTrials.gov processed this record on November 20, 2014