Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT01243658
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2010-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
"The Effects of Oxytocin on Patients With Borderline Personality Disorder"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001883', 'term': 'Borderline Personality Disorder'}], 'ancestors': [{'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-02', 'studyFirstSubmitDate': '2010-11-17', 'studyFirstSubmitQcDate': '2010-11-17', 'lastUpdatePostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BPD Symptoms', 'timeFrame': 'BPD Symptoms'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Oxytocin', 'BPD', 'Borderline'], 'conditions': ['Effects of Oxytocin on Borderline Personality Disorder', 'Borderline Personality Disorder']}, 'descriptionModule': {'briefSummary': 'RCT. Two substudies (clinical and experimental). Main objective of the trial is to examine if oxytocin, compared to placebo shows any additional effect on the therapy achievements (outcome) of patients with borderline personality disorder, who receive an in-patient standard psychotherapy (Dialectical-behavioral-therapy, Marsha Linehan (2006)).\n\nSecondary objectives :\n\nInvestigate if oxytocin compared to placebo enhances social trust and emotion recognition in patients with borderline personality disorder. Comparison of the effects of Oxytocin on patients with BPD and major depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gender: Both, male and female\n* Minimum Age: 18 Years\n* Maximum Age: 50 Years\n* Borderline personality disorder or major depression (clinical control group)\n* Mini Mental Status Test \\> 27 (capacity to consent)\n\nExclusion Criteria:\n\n* chronic or acute somatic health problems\n* Schizophrenia\n* Bipolar affective disorder\n* pregnancy\n* breast feeding\n* neurological disorder\n* allergy to antidegradants'}, 'identificationModule': {'nctId': 'NCT01243658', 'briefTitle': '"The Effects of Oxytocin on Patients With Borderline Personality Disorder"', 'organization': {'class': 'OTHER', 'fullName': 'University of Freiburg'}, 'officialTitle': '"The Effects of Oxytocin on Patients With Borderline Personality Disorder"', 'orgStudyIdInfo': {'id': 'OX02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxytocin', 'description': 'Oxytocin', 'interventionNames': ['Drug: Oxytocin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'Oxytocin', 'type': 'DRUG', 'description': 'Oxytocin', 'armGroupLabels': ['Oxytocin']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79104', 'city': 'Freiburg im Breisgau', 'state': 'Baden-Würtemberg', 'country': 'Germany', 'facility': 'Albert-Ludwigs-Universität-Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}], 'overallOfficials': [{'name': 'Markus Heinrichs, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut für Psychologie der Univeristät Freiburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Dr. Markus Heinrichs', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Markus Heinrichs', 'investigatorFullName': 'Prof. Dr. Markus Heinrichs', 'investigatorAffiliation': 'University of Freiburg'}}}}