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

Bipolar Disorder Clinical Trial

Official title:

Sleep Deprivation and Three Days Sleep Phase Advancement as Treatment for Bipolar Depression.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00229151
• Other study ID #: S2005.1.depr
• Status: Terminated
• Phase: N/A
• First received: September 27, 2005
• Last updated: April 6, 2012
• Start date: October 2005
• Est. completion date: December 2011

Study information

• Verified date: April 2012
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Bipolar disorder, depressive phase

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Sleep Deprivation

Intervention

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

Locations

Country	Name	City	State
Norway	Norwegian University of Science and Technology, Institute of Neuroscience	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores on rating scales for depression and symptom severity.		one month	No
Secondary	Scores on rating scales for anxiety, mania, cognitive processing, and sleep quality.		one month	No