Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-02-25 @ 7:22 PM
Study NCT ID:
NCT01821469
Status:
COMPLETED
Last Update Posted:
2014-01-28
First Post:
2012-11-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Correlates of Bipolar Disorders and Effects of the Psychoeducation. an fMRI Study
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-27', 'studyFirstSubmitDate': '2012-11-06', 'studyFirstSubmitQcDate': '2013-03-29', 'lastUpdatePostDateStruct': {'date': '2014-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fMRI measurement (neurophysiological [fMRI - activation and functional connectivity])', 'timeFrame': 'measurements were performed at T1 and T2 (up to 3 months)', 'description': 'measurements were performed before (T1) and after (T2) educational program of 12 sessions .One session last one hour and half once a week (they come at the hospital for all sessions : i.e. during 12 weeks). Thus, T1 to T2 is 3 months (average).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bipolar disorders', 'euthymic', 'psychotherapy', 'Functional magnetic resonance imaging'], 'conditions': ['Conditions Influencing Health Status', 'Bipolar Disorders']}, 'referencesModule': {'references': [{'pmid': '26244883', 'type': 'DERIVED', 'citation': 'Favre P, Polosan M, Pichat C, Bougerol T, Baciu M. Cerebral Correlates of Abnormal Emotion Conflict Processing in Euthymic Bipolar Patients: A Functional MRI Study. PLoS One. 2015 Aug 5;10(8):e0134961. doi: 10.1371/journal.pone.0134961. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'This research project follows two main objectives: 1) Assess anatomical and functional cerebral abnormalities in bipolar disorder. 2) Evaluate anatomical and functional changes after the application of a psychoeducational program in these patients. Specifically, this project aims to assess neurophysiological (fMRI - activation and functional connectivity) and neuroanatomical (morphometry and diffusion tensor imaging) specificities related to bipolar disorders and the therapeutic response to the psychoeducation. The results of this thesis project would also contribute to the validation of a pathophysiological model of the bipolar disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of bipolar disorders\n* euthymic (Montgomery and Asberg depression rating scale \\< 10, Young Mania rating scale \\< 10)\n\nExclusion Criteria:\n\n* other concomitant psychiatric disorders'}, 'identificationModule': {'nctId': 'NCT01821469', 'acronym': 'BIP-ED', 'briefTitle': 'Functional Correlates of Bipolar Disorders and Effects of the Psychoeducation. an fMRI Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Functional Correlates of Bipolar Disorders and Effects of the Psychoeducation. Assessment by Functional and Anatomic Neuroimaging.', 'orgStudyIdInfo': {'id': 'EssaiClinique_"BIP-ED"'}, 'secondaryIdInfos': [{'id': '2011-A00425-36', 'type': 'OTHER', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'psychoeducation', 'description': 'psychoeducation (12 weeks)', 'interventionNames': ['Behavioral: psychoeducation']}], 'interventions': [{'name': 'psychoeducation', 'type': 'BEHAVIORAL', 'description': 'Bipolar disorders are educated to learn about their pathology', 'armGroupLabels': ['psychoeducation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'Ums Irmage', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Thierry Bougerol, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU grenoble pôle psychiatrie et neurologie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'AdministrateurDRC', 'investigatorAffiliation': 'University Hospital, Grenoble'}}}}