Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-02-25 @ 9:50 PM
Study NCT ID:
NCT03227133
Status:
UNKNOWN
Last Update Posted:
2017-07-24
First Post:
2017-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Fluency and the Response to Antidepressant Therapy in the Elderly With a Unipolar Depressive Episode
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2019-06-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-21', 'studyFirstSubmitDate': '2017-07-21', 'studyFirstSubmitQcDate': '2017-07-21', 'lastUpdatePostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ability of the verbal fluency test score to predict the response to antidepressive treatment', 'timeFrame': 'week 10', 'description': 'verbal fluency is assessed during the neuropsychological assessment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Unipolar Depression']}, 'descriptionModule': {'briefSummary': 'The study focuses on the identification of clinical, physiological and morphological markers that could predict the response to antidepressant in elderly suffering from unipolar depressive disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Depressive episode according to DSM-5 criteria\n* Unipolar depression\n* MADRS ≥ 20\n* Antidepressive treatment (Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors)\n\nExclusion Criteria:\n\n* Other comorbid mental disorders (bipolar disorder, schizophrenia, recent addiction \\< 3 months except for tobacco)\n* Depression with psychotic features\n* Serious unstabilized somatic illness\n* Protected persons\n* Dementia suspected at the time of enrollment'}, 'identificationModule': {'nctId': 'NCT03227133', 'acronym': 'PREDICTage', 'briefTitle': 'Oral Fluency and the Response to Antidepressant Therapy in the Elderly With a Unipolar Depressive Episode', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'An Exploratory Study of the Use of Oral Fluency as a Predictive Tool for the Antidepressant Response of Elderly With Unipolar Depressive Disorder', 'orgStudyIdInfo': {'id': 'P/2016/297'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm', 'description': 'Psychiatric interview, Neuropsychological evaluations, cardiovascular risk assessment', 'interventionNames': ['Other: Neuropsychological evaluations', 'Other: Psychiatric interview', 'Other: Cardiovascular risk assessment']}], 'interventions': [{'name': 'Neuropsychological evaluations', 'type': 'OTHER', 'description': 'Neuropsychological evaluations including oral fluency, performed specifically for the study', 'armGroupLabels': ['Single arm']}, {'name': 'Psychiatric interview', 'type': 'OTHER', 'armGroupLabels': ['Single arm']}, {'name': 'Cardiovascular risk assessment', 'type': 'OTHER', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julie Monnin, PhD', 'role': 'CONTACT', 'email': 'jmonnin@chu-besancon.fr'}, {'name': 'Caroline Masse-Sibille, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Emmanuel Haffen, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nazim Nekrouf, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pierre Vandel, MS, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'centralContacts': [{'name': 'Julie Monnin, PhD', 'role': 'CONTACT', 'email': 'jmonnin@chu-besancon.fr'}], 'overallOfficials': [{'name': 'Caroline Masse-Sibille, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Besançon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}