Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-02-20 @ 6:25 PM
Study NCT ID:
NCT00229151
Status:
TERMINATED
Last Update Posted:
2012-04-09
First Post:
2005-09-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Deprivation and Advancement of Sleep Period as Treatment for Bipolar Depression.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'recruiting problems', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-06', 'studyFirstSubmitDate': '2005-09-27', 'studyFirstSubmitQcDate': '2005-09-28', 'lastUpdatePostDateStruct': {'date': '2012-04-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scores on rating scales for depression and symptom severity.', 'timeFrame': 'one month'}], 'secondaryOutcomes': [{'measure': 'Scores on rating scales for anxiety, mania, cognitive processing, and sleep quality.', 'timeFrame': 'one month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bipolar Disorder']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAim: To explore if sleep deprivation and three days sleep phase advancement is effective treatment for inpatients with bipolar disorder in a depressive phase.\n\nMethod: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bipolar disorder, depressive phase\n\nExclusion Criteria:\n\n* substance abuse, psychotic symptoms, suicidal intentions, active mania/hypomania.'}, 'identificationModule': {'nctId': 'NCT00229151', 'briefTitle': 'Sleep Deprivation and Advancement of Sleep Period as Treatment for Bipolar Depression.', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Sleep Deprivation and Three Days Sleep Phase Advancement as Treatment for Bipolar Depression.', 'orgStudyIdInfo': {'id': 'S2005.1.depr'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sleep deprivation', 'description': 'Sleep deprivation and sleep phase advancement', 'interventionNames': ['Behavioral: Sleep deprivation and sleep phase advancement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'usual treatment', 'interventionNames': ['Other: usual treatment']}], 'interventions': [{'name': 'Sleep deprivation and sleep phase advancement', 'type': 'BEHAVIORAL', 'description': 'Total sleep deprivation from 0800 to 1700 next day, and three day sleep phase advancement following sleep deprivation.', 'armGroupLabels': ['Sleep deprivation']}, {'name': 'usual treatment', 'type': 'OTHER', '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', 'armGroupLabels': ['usual treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7489', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'Norwegian University of Science and Technology, Institute of Neuroscience', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Gunnar Morken, PhD MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}