Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT06369805
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2024-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EVALUATION OF BLOOD BIOMARKER-BASED DIAGNOSTIC AID IN OUTPATIENTS SUFFERING FROM DEPRESSION
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 307}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-12', 'studyFirstSubmitDate': '2024-04-12', 'studyFirstSubmitQcDate': '2024-04-12', 'lastUpdatePostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychiatric symptomatology', 'timeFrame': 'Once', 'description': 'self- and hetero-psychiatric scales'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depressive Disorder', 'Bipolar Disorder', 'Bipolar Depression']}, 'descriptionModule': {'briefSummary': 'This is an observational (non-interventional) study, carried out in an outpatient setting, which involves a blood sampling. The primary objective of this study is to confirm the association between the EDIT-B® editing signature and early unipolar or bipolar differentiation. Results of this research may provide an aid to early diagnosis and guide clinical practice towards individualized treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult outpatients suffering from depression and/or bipolar disorders', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult outpatients suffering from depression and/or bipolar disorders who gave their written informed consent to participate in the present study\n\nExclusion Criteria:\n\nAny patient without capacity of discernment or with harmful use of psychoactive substances'}, 'identificationModule': {'nctId': 'NCT06369805', 'briefTitle': 'EVALUATION OF BLOOD BIOMARKER-BASED DIAGNOSTIC AID IN OUTPATIENTS SUFFERING FROM DEPRESSION', 'organization': {'class': 'OTHER', 'fullName': 'Les Toises - Psychiatry and Psychotherapy Center'}, 'officialTitle': "EVALUATION DE L'AIDE AU DIAGNOSTIC PAR BIOMARQUEURS SANGINS CHEZ DES PATIENTS SOUFFRANT DE DEPRESSION SUIVIS EN AMBULATOIRE", 'orgStudyIdInfo': {'id': '2021-00731'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'one group', 'interventionNames': ['Other: there is no intervention']}], 'interventions': [{'name': 'there is no intervention', 'type': 'OTHER', 'description': 'there is no intervention', 'armGroupLabels': ['one group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1005', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Les Toises - Psychiatry and Psychotherapy Center', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Les Toises - Psychiatry and Psychotherapy Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}