Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2026-02-11 @ 8:11 AM
Study NCT ID:
NCT02336568
Status:
UNKNOWN
Last Update Posted:
2015-01-13
First Post:
2015-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of 21-Days Intranasal Oxytocin on Patients With Post Traumatic Stress Disorder (PTSD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-12', 'studyFirstSubmitDate': '2015-01-08', 'studyFirstSubmitQcDate': '2015-01-12', 'lastUpdatePostDateStruct': {'date': '2015-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Semi-structured interviews (CAPS)and self-report questionnaires that examine the symptoms of the disorder and related symptoms (social function and aggressive behavior)', 'timeFrame': '3 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PTSD, Oxytocin'], 'conditions': ['PTSD']}, 'descriptionModule': {'briefSummary': 'Oxytocin (OT) - a neurohormone and neuromodulator which is mainly synthesized in the hypothalamus - is a mediator stress regulation and improves social bonding. Recently, several theoretical studies suggested that PTSD patients have abnormal functioning of the OT system. According to these theories, dysfunction in the oxytocin system may modulate the interpersonal impairment that characterizes PTSD, and therefore intranasal OT may potentially relieve these symptoms. In two current studies that were conducted in Rambam health care we found that a single dose of intranasal OT reduces anxiety and irritability symptoms, and enhances emotional empathy and compassion, in patients with PTSD. The main goal of this study is to examine the effects of 21-days intranasal Oxytocin on clinical symptoms and social function in these patients.', 'detailedDescription': 'This study will examine the effect is of 21-days intranasal Oxytocin on clinical symptoms and social function in these patients, in a double blind (treatment/placebo) study design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PTSD patients (DSM-IV criteria)\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Suicidality\n* Psychosis\n* Borderline Personality\n* Arrhythmia\n* Cardiac disease (arrythmia, heart failure)\n* Hyponatremia\n* Hypertension\n* Severe renal insufficiency\n* Liver cirrhosis\n* Lactating or pregnant women, or undergoing fertility treatment'}, 'identificationModule': {'nctId': 'NCT02336568', 'briefTitle': 'The Effect of 21-Days Intranasal Oxytocin on Patients With Post Traumatic Stress Disorder (PTSD)', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'The Effect of 21-Days Intranasal Oxytocin on Clinical Symptoms and Social Function in Patients With Post Traumatic Stress Disorder (PTSD), a Randomized Controled Trail', 'orgStudyIdInfo': {'id': '370-14CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'intervention: Oxytoine treatments - 20 PTSD patients', 'interventionNames': ['Drug: Oxytoine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo treatments', 'description': 'Other: Placebo treatments- 20 PTSD patients', 'interventionNames': ['Drug: PLACEBO']}], 'interventions': [{'name': 'Oxytoine', 'type': 'DRUG', 'otherNames': ['syntocinon nasal spray nasal'], 'description': 'In the first week 24 IU \\* 2/day. in the 2nd \\& 3rd 40 IU \\* 2/day', 'armGroupLabels': ['intervention']}, {'name': 'PLACEBO', 'type': 'DRUG', 'description': 'In the first week 24 IU \\* 2/day. in the 2nd \\& 3rd 40 IU \\* 2/day', 'armGroupLabels': ['Placebo treatments']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ehud Klein, Prof.', 'role': 'CONTACT', 'email': 'e_klein@rambam.health.gov.il', 'phone': '972-4-7772559'}, {'name': 'Sharon Palgi, Ph.D.', 'role': 'CONTACT', 'email': 's_palgi@rambam.health.gov.il', 'phone': '972-4-7773032'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}