Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 4:35 AM
Study NCT ID:
NCT07345858
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-01-16
First Post:
2026-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Salivary Oxytocin as a Biomarker of Psychedelic Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Salivary samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-07', 'studyFirstSubmitDate': '2026-01-07', 'studyFirstSubmitQcDate': '2026-01-07', 'lastUpdatePostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Salivary Oxytocin', 'timeFrame': 'One day', 'description': 'Measure taken during psychedelic treatment'}], 'secondaryOutcomes': [{'measure': 'Beck Depression Inventory', 'timeFrame': '3 months', 'description': 'Self-reported depressive symptoms'}, {'measure': 'Cognitive Flexibility Inventory', 'timeFrame': '3 months', 'description': 'Self-reported flexibility questionnaire'}, {'measure': 'Trait anxiety inventory (STAI-T)', 'timeFrame': '3 months', 'description': 'Self-reported anxiety symptoms'}, {'measure': 'Cognitive Emotion Regulation Questionnaire (CERQ)', 'timeFrame': '3 months', 'description': 'Self-reported cognitive emotion regulation strategies'}, {'measure': 'Emotion Regulation Questionnaire', 'timeFrame': '3 months', 'description': 'self-reported emotion regulation strategies'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oxytocin', 'psychedelics', 'lsd', 'psilocybin', 'Depression'], 'conditions': ['Major Depressive Disorder (MDD)']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate whether oxytocin reactivity during a psychedelic session for MDD treatment predicts treatment response, specifically by examining its relationship with changes in flexibility and depressive symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be invited to participate among consecutive patients with treatment-resistant MDD enrolled for psychedelic treatment in the Division of addictology-Department of Psychiatry of the Geneva University hospitals) after receiving approval from the Swiss Federal Office of Public health for compassionate treatment with LSD or psilocybin. Only those receiving LSD or psilocybin for the first time (first treatment cycle) will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>=18 years-old\n* MDD defined by DSM-V criteria, and resistant to treatment\n* Ongoing classical psychotherapeutic treatment\n* Agreement to discontinue necessary psychotropic medications (some classes of anti-depressants are allowed with no need to taper off).\n\nExclusion Criteria:\n\n* Psychotic or bipolar disorder\n* High suicidal risk\n* Severe cardiovascular, hepatic or neurological (affecting the central nervous system) disorders\n* Pregnancy or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT07345858', 'acronym': 'PAPOXT_MDD', 'briefTitle': 'Salivary Oxytocin as a Biomarker of Psychedelic Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Geneva, Switzerland'}, 'officialTitle': 'Salivary Oxytocin as a Biomarker of Psychedelic Assisted Psychotherapy in Patients With Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'BASEC ID 2025-02092'}}, 'contactsLocationsModule': {'locations': [{'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Geneva University Hospitals', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Geneva, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Tatiana Aboulafia Brakha', 'investigatorAffiliation': 'University of Geneva, Switzerland'}}}}