NCT00229151

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2005

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 9, 2012

Status Verified

April 1, 2012

Enrollment Period

6.2 years

First QC Date

September 27, 2005

Last Update Submit

April 6, 2012

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • Scores on rating scales for depression and symptom severity.

    one month

Secondary Outcomes (1)

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

    one month

Study Arms (2)

Sleep deprivation

EXPERIMENTAL

Sleep deprivation and sleep phase advancement

Behavioral: Sleep deprivation and sleep phase advancement

usual treatment

ACTIVE COMPARATOR
Other: usual treatment

Interventions

Sleep deprivation and sleep phase advancementBEHAVIORAL

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

Sleep deprivation
usual treatmentOTHER

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

usual treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bipolar disorder, depressive phase

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology, Institute of Neuroscience

Trondheim, 7489, Norway

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Gunnar Morken, PhD MD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2005

First Posted

September 29, 2005

Study Start

October 1, 2005

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

April 9, 2012

Record last verified: 2012-04

Locations

NO(1)