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

Primary Purpose

Bipolar Disorder

Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Sleep deprivation and sleep phase advancement
usual treatment
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Bipolar disorder, depressive phase Exclusion Criteria: substance abuse, psychotic symptoms, suicidal intentions, active mania/hypomania.

Sites / Locations

  • Norwegian University of Science and Technology, Institute of Neuroscience

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sleep deprivation

usual treatment

Arm Description

Sleep deprivation and sleep phase advancement

Outcomes

Primary Outcome Measures

Scores on rating scales for depression and symptom severity.

Secondary Outcome Measures

Scores on rating scales for anxiety, mania, cognitive processing, and sleep quality.

Full Information

First Posted
September 27, 2005
Last Updated
April 6, 2012
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT00229151
Brief Title
Sleep Deprivation and Advancement of Sleep Period as Treatment for Bipolar Depression.
Official Title
Sleep Deprivation and Three Days Sleep Phase Advancement as Treatment for Bipolar Depression.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Terminated
Why Stopped
recruiting problems
Study Start Date
October 2005 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep deprivation
Arm Type
Experimental
Arm Description
Sleep deprivation and sleep phase advancement
Arm Title
usual treatment
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Sleep deprivation and sleep phase advancement
Intervention Description
Total sleep deprivation from 0800 to 1700 next day, and three day sleep phase advancement following sleep deprivation.
Intervention Type
Other
Intervention Name(s)
usual treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
Scores on rating scales for depression and symptom severity.
Time Frame
one month
Secondary Outcome Measure Information:
Title
Scores on rating scales for anxiety, mania, cognitive processing, and sleep quality.
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Bipolar disorder, depressive phase Exclusion Criteria: substance abuse, psychotic symptoms, suicidal intentions, active mania/hypomania.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunnar Morken, PhD MD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norwegian University of Science and Technology, Institute of Neuroscience
City
Trondheim
ZIP/Postal Code
7489
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

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

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