Sleep Deprivation and Advancement of Sleep Period as Treatment for Bipolar Depression.
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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. |
- Scores on rating scales for depression and symptom severity. [ Time Frame: one month ] [ Designated as safety issue: No ]
- 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 |
Inclusion Criteria:
- Bipolar disorder, depressive phase
Exclusion Criteria:
- substance abuse, psychotic symptoms, suicidal intentions, active mania/hypomania.
Contacts and Locations| Norway | |
| Norwegian University of Science and Technology, Institute of Neuroscience | |
| Trondheim, Norway, 7489 | |
| 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 Depressive Disorder Sleep Deprivation Affective Disorders, Psychotic Mood Disorders Mental Disorders |
Behavioral Symptoms Dyssomnias Sleep Disorders Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013