Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-01-24 @ 6:29 AM
Study NCT ID:
NCT03031405
Status:
COMPLETED
Last Update Posted:
2018-08-21
First Post:
2017-01-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Oxytocin on the Acquisition and Consolidation of Trauma-Associated Memories
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-19', 'studyFirstSubmitDate': '2017-01-18', 'studyFirstSubmitQcDate': '2017-01-23', 'lastUpdatePostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intrusive memories', 'timeFrame': 'four consecutive days', 'description': 'Influence of oxytocin on the development of intrusive memories measured with an intrusion diary'}], 'secondaryOutcomes': [{'measure': 'Noradrenergic System (measured with salivary alpha-amylase - u/ml)', 'timeFrame': 'Day 1', 'description': 'Influence of oxytocin on the noradrenergic system measured with salivary alpha-amylase'}, {'measure': 'Genetic polymorphism', 'timeFrame': 'four consecutive days', 'description': 'Influence of genetic polymorphism of the oxytocin receptor on intrusive memories measured with an intrusion diary'}, {'measure': 'Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)', 'timeFrame': 'Day 1', 'description': 'Influence of oxytocin on the HPA-axis measured with salivary cortisol'}]}, 'conditionsModule': {'conditions': ['Intrusive Memories']}, 'referencesModule': {'references': [{'pmid': '34887528', 'type': 'DERIVED', 'citation': 'Schultebraucks K, Maslahati T, Wingenfeld K, Hellmann-Regen J, Kraft J, Kownatzki M, Behnia B, Ripke S, Otte C, Roepke S. Intranasal oxytocin administration impacts the acquisition and consolidation of trauma-associated memories: a double-blind randomized placebo-controlled experimental study in healthy women. Neuropsychopharmacology. 2022 Apr;47(5):1046-1054. doi: 10.1038/s41386-021-01247-4. Epub 2021 Dec 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to examine whether oxytocin and oxytocin receptor gene polymorphism affect the development of intrusive memories, a cardinal symptom of PTSD.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy female volunteers\n* German on a native level\n\nExclusion Criteria:\n\n* former or present disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5)\n* any physical illnesses\n* any medication intake (except oral contraceptive)\n* history of traumatic experience, e.g. history of sexual abuse or rape\n* pregnancy or lactation period\n* follicular phase of menstrual cycle for all women not using oral contraceptives'}, 'identificationModule': {'nctId': 'NCT03031405', 'briefTitle': 'The Effect of Oxytocin on the Acquisition and Consolidation of Trauma-Associated Memories', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'The Effect of Oxytocin on the Acquisition and Consolidation of Trauma-Associated Memories: A Model to Understand the Development of Posttraumatic Stress Disorder', 'orgStudyIdInfo': {'id': 'Charite2017-Oxytocin-Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxytocin and trauma film paradigm', 'interventionNames': ['Drug: Oxytocin nasal spray']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo and trauma film paradigm', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Oxytocin nasal spray', 'type': 'DRUG', 'armGroupLabels': ['Oxytocin and trauma film paradigm']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Placebo nasal spray', 'armGroupLabels': ['Placebo and trauma film paradigm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12203', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Stefan Roepke, PD Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Central Institute of Mental Health, Mannheim', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Katharina Schultebraucks', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}