Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-03-09 @ 1:57 AM
Study NCT ID:
NCT06589505
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2024-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Software as a Medical Device for the Treatment of Patients With PTSD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003130', 'term': 'Combat Disorders'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2024-08-22', 'studyFirstSubmitQcDate': '2024-09-09', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinician-Administered PTSD Scale for DSM-5', 'timeFrame': 'baseline and after intervention (up to 21 weeks)', 'description': 'The primary objective of this study is to assess the change from baseline of the Clinician Administered PTSD Scale (CAPS - 5) score.\n\nScores range from 0 - 80, with higher scores indicating increased PTSD symptom severity.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-Traumatic Stress Disorder, PTSD']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of Software as a Medical Device in patients with Post-Traumatic Stress Disorder (PTSD)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of PTSD according to the DSM-5\n* Subjects who are within 1 to 20 years since index trauma\n\nExclusion Criteria:\n\n* Subjects diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, bipolar I disorder, autism spectrum disorder, or intellectual disability based on DSM-5.\n* Subjects diagnosed with any mood disorder and anxiety disorder according to DSM-5 that is the primary focus of treatment in the last 6 months prior to screening, as per the clinical judgement of the investigator\n* Subjects who have completed two or more full courses of trauma-focused therapy in the past'}, 'identificationModule': {'nctId': 'NCT06589505', 'briefTitle': 'Software as a Medical Device for the Treatment of Patients With PTSD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Medical Devices Co., Ltd. Japan'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Parallel-group Comparative Study to Assess Efficacy and Safety of Software as a Medical Device in Patients With Post-Traumatic Stress Disorder (PTSD)', 'orgStudyIdInfo': {'id': '380-102-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The Software as a Medical Device1', 'interventionNames': ['Device: Software as a Medical Device']}, {'type': 'OTHER', 'label': 'The Software as a Medical Device2', 'interventionNames': ['Device: Software as a Medical Device']}], 'interventions': [{'name': 'Software as a Medical Device', 'type': 'DEVICE', 'description': 'The subject will undergo treatment using the Software as a Medical Device', 'armGroupLabels': ['The Software as a Medical Device1', 'The Software as a Medical Device2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yamanashi', 'state': 'Hokkaido', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Yamanashi Prefectural Kita Hospital'}, {'city': 'Akita', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Heart Care Clinic Omachi', 'geoPoint': {'lat': 39.71667, 'lon': 140.11667}}, {'city': 'Fukuoka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Aburayama Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Ai Sakura Clinic', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Hatakeyama Clinic', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Hiro Mental Clinic', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Hirota Clinic', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Kurume University Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Medical corporation Shinseikai Kaku Mental Clinic', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Mental Clinic Sakurazaka', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Nishie Kokorono Clinic', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Uematsu Mental Clinic', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Gunma', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'PTSD Care Matsumoto Mental Clinic'}, {'city': 'Hokkaido', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Goryokai Hospital'}, {'city': 'Hyōgo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Sakamoto Misako Mental Clinic', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'city': 'Hyōgo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Takahashi Psychiatric Clinic', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'city': 'Ibaraki', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Tsukuba Psychosomatics Clinic', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'city': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Musashikosugi J Kokorono Clinic', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'city': 'Kumamoto', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Niki Hearty Hospital', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Nagasaki', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Arata Clinic', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'city': 'Okayama', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Okayama Psychiatric Medical Center', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Okinawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Barclay Imuro Mental Clinic', 'geoPoint': {'lat': 26.33583, 'lon': 127.80139}}, {'city': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Medical Corporation Mikokorokai Shimizu Clinic', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Saitama', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Sho Midori Hospital', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Tochigi', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Ai Mental Clinic', 'geoPoint': {'lat': 36.38333, 'lon': 139.73333}}, {'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'i Kokoro Clinic Nihonbashi', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Iidabashi Mental Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT', 'phone': '+81-3-6361-7459'}], 'facility': 'Ikebukuro Olive Mental Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Kitaikebukuro Kokoro No Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Maynds Tower Mental Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Monzennakacho Mental Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Nippon Medical School Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Sakurazaka Clinic SophyAnce', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Sangenjaya Nakamura Mental Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT'}], 'facility': 'Wakamatsucho Kokoro to Hifu Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'centralContacts': [{'name': 'Kentaro Ishinabe', 'role': 'CONTACT', 'email': 'OtsukaRegistry-CT@otsuka.jp', 'phone': '+81-3-6361-7459'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Medical Devices Co., Ltd. Japan', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}