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

NCT ID: NCT00229151

Last Updated: 2012-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sleep deprivation

Sleep deprivation and sleep phase advancement

Group Type EXPERIMENTAL

Sleep deprivation and sleep phase advancement

Intervention Type BEHAVIORAL

Total sleep deprivation from 0800 to 1700 next day, and three day sleep phase advancement following sleep deprivation.

usual treatment

Group Type ACTIVE_COMPARATOR

usual treatment

Intervention Type OTHER

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

Interventions

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Sleep deprivation and sleep phase advancement

Total sleep deprivation from 0800 to 1700 next day, and three day sleep phase advancement following sleep deprivation.

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Bipolar disorder, depressive phase

Exclusion Criteria

* substance abuse, psychotic symptoms, suicidal intentions, active mania/hypomania.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gunnar Morken, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

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Norwegian University of Science and Technology, Institute of Neuroscience

Trondheim, , Norway

Site Status

Countries

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Norway

Other Identifiers

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S2005.1.depr

Identifier Type: -

Identifier Source: org_study_id

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