Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-30 @ 4:22 AM
Study NCT ID:
NCT04044534
Status:
RECRUITING
Last Update Posted:
2025-09-16
First Post:
2019-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intranasal Insulin for Posttraumatic Stress Disorder
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2019-08-01', 'studyFirstSubmitQcDate': '2019-08-01', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-traumatic stress disorder (PTSD) symptoms as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)', 'timeFrame': '1 week', 'description': 'The five-point CAPS-5 consists of 20 PTSD symptoms rated on a 0-4 scale (total range: 0-80) as follows: (1) 5 Intrusion symptoms (0-20), (2) 2 Avoidance symptoms (0-8), (3) 7 Cognitions and mood symptoms (0-28), and (4) 6 Arousal and reactivity symptoms (0-24). Higher scores represent a worse outcome (i.e., more PTSD symptoms).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intranasal insulin', 'PTSD'], 'conditions': ['PTSD']}, 'descriptionModule': {'briefSummary': 'To evaluate if intranasal insulin is effective in reducing PTSD symptoms.', 'detailedDescription': 'The current proposal aims to study the pharmacotherapeutic effects of intranasal insulin on PTSD symptoms and inhibition of amygdala hyperactivation in subjects with PTSD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, 21-65 years old\n* Current PTSD\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Unstable medical condition, clinically determined by a physician\n* Diabetes requiring insulin or oral hypoglycemic agents\n* Moderate-severe traumatic brain injury\n* Current psychotic disorder, bipolar disorder, cognitive disorder in the past 12 months\n* Current substance use disorders (except alcohol, tobacco, or cannabis) in the past 3 months\n* Changes in doses of psychotropic medications in the past 4 weeks\n* Initiation of individual therapy or counseling in the past 4 weeks\n* Imminent suicidal or homicidal risk\n* Contraindication to Insulin\n* History of claustrophobia\n* Presence of cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a standard pre-MRI safety screening questionnaire'}, 'identificationModule': {'nctId': 'NCT04044534', 'briefTitle': 'Intranasal Insulin for Posttraumatic Stress Disorder', 'organization': {'class': 'FED', 'fullName': 'VA Connecticut Healthcare System'}, 'officialTitle': 'Intranasal Insulin for Treating Posttraumatic Stress Disorder', 'orgStudyIdInfo': {'id': 'GY0005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intranasal insulin', 'description': 'Subjects in this arm will receive 40 IU of intranasal insulin twice a day (80 IU per day).', 'interventionNames': ['Drug: Intranasal insulin']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Subjects in this arm will receive placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Intranasal insulin', 'type': 'DRUG', 'description': 'Subjects in this arm will receive intranasal insulin (80 IU per day).', 'armGroupLabels': ['Intranasal insulin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects in this arm will receive placebo.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06516', 'city': 'West Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gihyun Yoon, MD', 'role': 'CONTACT', 'email': 'gihyun.yoon@yale.edu', 'phone': '203-932-5711', 'phoneExt': '7421'}], 'facility': 'VA Connecticut Healthcare System', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}], 'centralContacts': [{'name': 'Gihyun Yoon, MD', 'role': 'CONTACT', 'email': 'gihyun.yoon@yale.edu', 'phone': '(203) 932-5711', 'phoneExt': '7421'}], 'overallOfficials': [{'name': 'Gihyun Yoon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Connecticut Healthcare System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Connecticut Healthcare System', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gihyun Yoon, MD', 'investigatorAffiliation': 'VA Connecticut Healthcare System'}}}}