Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-07-10 @ 5:38 AM
Study NCT ID:
NCT02778256
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2016-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Effectiveness of Vestibular Stimulation Treatment in the Depressive Phase of Bipolar Disorder
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2016-05-17', 'studyFirstSubmitQcDate': '2016-05-18', 'lastUpdatePostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remission rates of depression.', 'timeFrame': '90 days'}], 'secondaryOutcomes': [{'measure': 'Percentage of vestibular change.', 'timeFrame': '90 days'}, {'measure': 'Response rates of depression', 'timeFrame': '90 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['depression, bipolar disorder'], 'conditions': ['Bipolar Disorder', 'Depression, Bipolar']}, 'descriptionModule': {'briefSummary': 'Vestibular stimulation has been shown to be a very effective noninvasive treatment for major depression. Bipolar disorder is a mental illness that presents cyclic sequences of depressive and euphoric states. Depressive phases of bipolar disorder are difficult to treat and usually are resistant to actual available treatments. This study investigates the effectiveness of a particular technique of vestibular stimulation in a group of 120 bipolar type I and II patients. After randomization 60 of them will receive specific vestibular stimulation (experimental group) and 60 will receive a sham vestibular stimulation.The study will conducted in Vest Brain, Centro de Estudios Neurovestibulares, in Chile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* males\n* females\n* 3 previous weeks with depression symptoms.\n* bipolar disorder type I actual depressive phase\n* bipolar disorder type II actual depressive phase\n* Montgomery Asberg depression scale(MADRS) score equal or more than 20\n* stable psychiatric medication during 2 weeks previous the recruitment\n\nExclusion Criteria:\n\n* pregnancy\n* neurologic disorder\n* drugs or alcohol abuse during the 2 weeks previous the recruitment\n* presence of maniac state(Young mania scale score more than 7)'}, 'identificationModule': {'nctId': 'NCT02778256', 'briefTitle': 'Study of the Effectiveness of Vestibular Stimulation Treatment in the Depressive Phase of Bipolar Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Vest Brain,Centro de Estudios Neurovestibulares'}, 'officialTitle': 'Study of the Effectiveness of Vestibular Stimulation as a Coadjuvant Treatment in the Depressive Phase of Bipolar Disorder', 'orgStudyIdInfo': {'id': 'VESTBRAIN001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vestibular stimulation', 'description': 'Patients of this group will receive a specific vestibular stimulation technique.', 'interventionNames': ['Device: Vestibular stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham vestibular stimulation', 'description': 'This group of patients will receive sham vestibular stimulation, similar to experimental group vestibular stimulation in the range of under threshold frequencies undistinguished from real vestibular stimulation. The absence of vestibular nystagmic response confirms that the stimulus is sham.', 'interventionNames': ['Device: Sham vestibular stimulation']}], 'interventions': [{'name': 'Vestibular stimulation', 'type': 'DEVICE', 'description': 'A specific vestibular stimulation technique is applied to the experimental group', 'armGroupLabels': ['Vestibular stimulation']}, {'name': 'Sham vestibular stimulation', 'type': 'DEVICE', 'description': 'Sham vestibular stimulation using lower than threshold stimuli. The absence of vestibular nystagmus confirms that it is sham.', 'armGroupLabels': ['Sham vestibular stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7640617', 'city': 'Santiago', 'status': 'RECRUITING', 'country': 'Chile', 'contacts': [{'name': 'Ana M Soza, M.D.', 'role': 'CONTACT', 'email': 'amsozaried@vestbrain.cl', 'phone': '+56992896736'}], 'facility': 'Vest Brain, Centro de Estudios Neurovestibulares', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'centralContacts': [{'name': 'Ana M Soza, M.D.', 'role': 'CONTACT', 'email': 'amsozaried@vestbrain.cl', 'phone': '+56992896736'}], 'overallOfficials': [{'name': 'Ana M Soza, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vest Brain,Centro de Estudios Neurovestibulares'}]}, 'ipdSharingStatementModule': {'url': 'https://www.vestbrain.cl', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'The data will be available in December 2019-March 2020 and can be asked to Dr. Ana María Soza´s email amsozaried@vestbrain.cl', 'ipdSharing': 'YES', 'description': "IPD will be shared with other researchers by asking for the information to Dr. Ana María Soza's email: amsozaried@vestbrain.cl", 'accessCriteria': 'The criteria to access is asking for the information to Dr. Ana María Soza´s email amsozaried@vestbrain.cl'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vest Brain,Centro de Estudios Neurovestibulares', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}