Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-04 @ 3:38 PM
Study NCT ID:
NCT06369792
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PROSPECTIVE EVALUATION OF BLOOD BIOMARKERS AS AN AID TO DIAGNOSTIC AND TREATMENT IN DRUG-NAIVE PATIENTS WITH 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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, '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': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'psychiatric symptomatology', 'timeFrame': 'At baseline, 1,2,4,8 weeks', 'description': 'self- and hetero-questionnaire psychiatric scales'}, {'measure': 'EDIT-B profiling', 'timeFrame': 'At baseline, 1,2,4,8 weeks', 'description': 'Measurement of RNA editing over time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depressive Disorder', 'Bipolar Disorder', 'Bipolar Depression']}, 'descriptionModule': {'briefSummary': 'This is an observational (non-interventional) prospective study, carried out in drug-naïve outpatients who start a treatment with escitalopram, fluoxetine, sertraline or quetiapine. Five blood samples are collected (i.e. before initiating the drug, and then after 1, 2, 4 and 8 weeks of treatment). It does not affect the choice or the treatment dose. The primary objective of this study is to measure the association between the EDIT-B® editing signature and response to pharmacological treatment in drug-naïve patients. Results of this research could provide an aid to early diagnosis, optimize pharmacological treatment and guide clinical practice towards individualized treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes drug-naïve adult outpatients (aged 18 or over) with depression (F32-33) and/or bipolar disorder (F30-F31) who start escitalopram, fluoxetine, sertraline or quetiapine.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult drug-naïve outpatients suffering from depression and/or bipolar disorders who start a pharmacological treatment with escitalopram, fluoxetine, sertraline or quetiapine and who gave his written informed consent to participate in the present study.\n\nExclusion Criteria:\n\n* Any patient without capacity of discernment or with harmful use of psychoactive substances'}, 'identificationModule': {'nctId': 'NCT06369792', 'briefTitle': 'PROSPECTIVE EVALUATION OF BLOOD BIOMARKERS AS AN AID TO DIAGNOSTIC AND TREATMENT IN DRUG-NAIVE PATIENTS WITH DEPRESSION', 'organization': {'class': 'OTHER', 'fullName': 'Les Toises - Psychiatry and Psychotherapy Center'}, 'officialTitle': "EVALUATION PROSPECTIVE DE L'AIDE AU DIAGNOSTIC ET AU TRAITEMENT PAR BIOMARQUEURS SANGUINS CHEZ DES PATIENTS DRUG-NAÏFS AMBULATOIRES SOUFFRANT DE DEPRESSION", 'orgStudyIdInfo': {'id': '2020-00266'}}, 'contactsLocationsModule': {'locations': [{'zip': '1005', 'city': 'Lausanne', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Aurélie Reymond-Delacrétaz, PhD', 'role': 'CONTACT', 'email': 'aurelie.delacretaz@lestoises.ch', 'phone': '+41584580580'}], 'facility': 'Les Toises - Psychiatry and Psychotherapy Center', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'centralContacts': [{'name': 'Aurélie Reymond-Delacrétaz, PhD', 'role': 'CONTACT', 'email': 'aurelie.delacretaz@lestoises.ch', 'phone': '0041 584-580-580'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Les Toises - Psychiatry and Psychotherapy Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}