Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 12:23 AM
Study NCT ID:
NCT07317232
Status:
RECRUITING
Last Update Posted:
2026-01-05
First Post:
2025-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ayahuasca, Esketamine and Premenstrual Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629870', 'term': 'Esketamine'}, {'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-19', 'studyFirstSubmitDate': '2025-12-19', 'studyFirstSubmitQcDate': '2025-12-19', 'lastUpdatePostDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Premenstrual Symptom Tracking Instrument (PSST)', 'timeFrame': 'From enrollment to the end of treatment at 3 weeks', 'description': 'higher scores mean a worse outcome'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Women Volunteers']}, 'descriptionModule': {'briefSummary': 'Double-blind, randomized trial comparing a single dose of oral ayahuasca or esketamine on premenstrual symptoms.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'healthy women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteers\n\nExclusion Criteria:\n\n* psychiatric and other medical comorbidities'}, 'identificationModule': {'nctId': 'NCT07317232', 'briefTitle': 'Ayahuasca, Esketamine and Premenstrual Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Effects of a Single Dose of Ayahuasca or Esketamine on the Menstrual Cycle and Premenstrual Symptoms: a Randomized, Double-Blind Study', 'orgStudyIdInfo': {'id': '85088224.9.0000.5440'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ayahuasca', 'description': 'oral ayahuasca', 'interventionNames': ['Drug: Ayahuasca']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'esketamine', 'description': 'oral esketamine', 'interventionNames': ['Drug: Esketamine']}], 'interventions': [{'name': 'Ayahuasca', 'type': 'DRUG', 'otherNames': ['aya'], 'description': 'oral ayahuasca', 'armGroupLabels': ['ayahuasca']}, {'name': 'Esketamine', 'type': 'DRUG', 'otherNames': ['ketamine'], 'description': 'oral esketamine', 'armGroupLabels': ['esketamine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ribeirão Preto', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Guimarães Santos', 'role': 'CONTACT', 'email': 'banisteria@gmail.com', 'phone': '5516997721969'}], 'facility': 'Hospital das Clínicas da FMRP-USP', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Rafael Guimarães dos Santos', 'investigatorAffiliation': 'University of Sao Paulo'}}}}