Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT01857518
Status:
UNKNOWN
Last Update Posted:
2017-10-20
First Post:
2013-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Depression in Adolescents. A Cerebral Structural, Diffusion, and Functional Magnetic Resonance Imaging Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D056324', 'term': 'Diffusion Tensor Imaging'}], 'ancestors': [{'id': 'D059906', 'term': 'Neuroimaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D038524', 'term': 'Diffusion Magnetic Resonance Imaging'}, {'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-18', 'studyFirstSubmitDate': '2013-05-16', 'studyFirstSubmitQcDate': '2013-05-17', 'lastUpdatePostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evidence of white matter microstructure changes', 'timeFrame': 'Baseline', 'description': 'Statistical map of voxel-based analysis of white matter using tract based spatial statistics (TBSS) to compare depressed adolescents and healthy controls in emotional and reward networks'}, {'measure': 'Evidence of grey matter volume changes', 'timeFrame': 'Baseline', 'description': 'Statistical map of voxel-based analysis of grey matter using statistical parametric mapping (SPM8) to compare depressed adolescents and healthy controls in emotional and reward networks'}], 'secondaryOutcomes': [{'measure': 'Correlation between Functional anatomy of emotional/reward responses and white matter and grey matter structure changes', 'timeFrame': 'Baseline'}, {'measure': 'Grey matter and white matter changes in frontal limbic networks at follow-up in treated patients', 'timeFrame': 'Follow-up one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adolescent Depression']}, 'descriptionModule': {'briefSummary': 'Adolescence is a critical period for the development of depressive disorders. As adolescence also is a critical period for brain maturation, it may be hypothesized that maturation changes in emotional circuits could underlie vulnerability for depression.\n\nThe aims of the study are (1) to identify the changes in brain morphometry, white matter microstructure, and functioning, in networks associated with depression features in adolescents, and (2) to assess the effects of treated pathology on brain structure by comparing the neuroimaging measures obtained in adolescents at inclusion with those at follow-up.', 'detailedDescription': 'Adolescence is a key development period for neurobiological processes underlying emotional and cognitive functions in adulthood. The pathophysiology of mood disorders has recently been associated with maturation changes in brain networks, but little is known on the early brain structure changes associated with depression appearing during this major brain maturation period.\n\nThe hypothesis of altered structural integrity of limbic prefrontal pathways emerges from the literature on depression, but it is unknown whether it is also detectable in adolescents with depression. Thus, we aim to investigate WM and GM structure and anatomy, and functional correlates of behavioral responses in depressed adolescents.\n\n40 adolescents with a Major Depressive Episode will be investigated using structural T1 magnetic-resonance imaging and diffusion tensor imaging (DTI), at inclusion and after one-year follow-up. Additionally, they will be investigated with fMRI.\n\nCovariation patterns between neuroimaging and behavioural/clinical variables will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDepressed adolescents:\n\nTeenagers of both sexes, from 15 to 18 years old, without contreindications in magnetic fields\n\n* affiliation to a Social insurance\n* Informed consent signed by the holders of the parental rights (a specific information note to the teenager)\n* Diagnosis DSM-IV-TR ( 2000 ) of depressive Disorder of the humor without psychotic characteristics. The symptoms will have to be persistent for 3 weeks, in spite of a coverage of support ( 2 consultations).\n\nExclusion Criteria:\n\n* Ferromagnetical Material in the body\n* Claustrophobia, Syndrom of post-traumatic stress, Obsessive-compulsive Disorder, Disturb Tricks, Disturbs abuse of substances\n* Intrusive disorder of the development, Disturbs hyperactivity deficit of the attention, Disorders of the conducts, Schizophrenia\n* Current antidepressant or antipsychotic psychotropic Treatment for more than 15 days in effective doses\n* Current somatic pathology, or pregnancy (urinary test of pregnancy in case of doubt)\n* Histories of cranial trauma or neurological pathology, or of lower born weight in 800g\n* History of electroconvulsivotherapy in the previous 6 months\n* Refusal to give his(her) consent or to be revised on one year after inclusion\n\nHealthy adolescents: will be screened to be matched to the patients according to age and sex. They will have no psychiatric diagnosis, and no family history of psychiatric conditions.'}, 'identificationModule': {'nctId': 'NCT01857518', 'acronym': 'ADODEP', 'briefTitle': 'Depression in Adolescents. A Cerebral Structural, Diffusion, and Functional Magnetic Resonance Imaging Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier St Anne'}, 'officialTitle': 'Depression in Adolescents. A Cerebral Structural, Diffusion, and Functional Magnetic Resonance Imaging Study.', 'orgStudyIdInfo': {'id': '2012-A01466-37'}, 'secondaryIdInfos': [{'id': 'D500', 'type': 'OTHER', 'domain': 'CHSA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Depressed adolescents Group', 'description': 'Adolescents with a major depressive episode diagnosis', 'interventionNames': ['Other: -Diagnostic, clinical and psycho-behavioral assessments -Neuroimaging: T1-MRI, DTI-MRI, fMRI']}, {'type': 'OTHER', 'label': 'Healthy adolescent control Group', 'description': 'Healthy adolescents recruited from general population', 'interventionNames': ['Other: -Diagnostic, clinical and psycho-behavioral assessments -Neuroimaging: T1-MRI, DTI-MRI, fMRI']}], 'interventions': [{'name': '-Diagnostic, clinical and psycho-behavioral assessments -Neuroimaging: T1-MRI, DTI-MRI, fMRI', 'type': 'OTHER', 'description': '* Visit V1: Diagnostic and clinical assessments\n* Visit V2: psycho-behavioral assessment and neuroimaging\n* Visit V3: Diagnostic and clinical assessments\n* Visit V4: psycho-behavioral assessment and neuroimaging', 'armGroupLabels': ['Depressed adolescents Group', 'Healthy adolescent control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75006', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie-Laure PAILLERE, MD, PhD', 'role': 'CONTACT', 'email': 'ml.paillere@cch.aphp.fr', 'phone': '+33158412426'}, {'name': 'Marie GODARD', 'role': 'CONTACT', 'email': 'm.godard@ch-sainte-anne.fr', 'phone': '0033145657728'}, {'name': 'Marie-Laure PAILLERE MARTINOT', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cochin Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Marie-Laure PAILLERE-MARTINOT, MD, PhD', 'role': 'CONTACT', 'email': 'ml.paillere@cch.aphp.fr', 'phone': '+33158412426'}, {'name': 'Marie GODARD', 'role': 'CONTACT', 'email': 'm.godard@ch-sainte-anne.fr', 'phone': '003345657728'}], 'overallOfficials': [{'name': 'Marie-Laure PAILLERE MARTINOT, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'APHP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier St Anne', 'class': 'OTHER'}, 'collaborators': [{'name': 'CENIR Centre de Neuroimagerie de Recherche, Paris', 'class': 'UNKNOWN'}, {'name': 'Inserm CEA Research unit U1000 (Neuroimaging in psychiatry)', 'class': 'UNKNOWN'}, {'name': 'National Research Agency, France', 'class': 'OTHER'}, {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}