Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2025-12-29 @ 3:14 AM
Study NCT ID:
NCT06215261
Status:
COMPLETED
Last Update Posted:
2025-11-25
First Post:
2024-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Evaluation of the Safety and Efficacy of Methylone for the Treatment of 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C400939', 'term': 'methylone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2024-01-10', 'studyFirstSubmitQcDate': '2024-01-10', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) total severity score', 'timeFrame': '9 weeks (Part A) / 12 weeks (Part B)', 'description': 'The CAPS-5 is a structured interview designed to assess PTSD symptom severity. The total severity score ranges from 0 to 80, with a higher score indicating more severe symptoms.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score', 'timeFrame': '9 weeks (Part A) / 12 weeks (Part B)', 'description': 'The MADRS is a 10-item, clinician-rated scale designed to assess severity of depression. The total score ranges from 0 to 60, with a higher score indicating more severe depression.'}, {'measure': 'Change from Baseline in PTSD Checklist for DSM-5 (PCL-5)', 'timeFrame': '9 weeks (Part A) / 12 weeks (Part B)', 'description': 'The PCL-5 is a 20-item, patient-rated scale designed to measure severity of PTSD symptoms. The total score ranges from 0 to 80, with a higher score indicating more severe PTSD symptoms.'}, {'measure': 'Change from Baseline in Sheehan Disability Scale (SDS)', 'timeFrame': '9 weeks (Part A) / 12 weeks (Part B)', 'description': 'The SDS is a 3-item, patient-rated scale designed to measure disability and impairment across three domains: work/school, social life, and family life/home responsibilities. Each domain is scored from 0 to 10, with higher scores representing greater disability. Total scores range from 0 to 30.'}, {'measure': 'Incidence of treatment-emergent adverse events (TEAEs)', 'timeFrame': '9 weeks (Part A) / 12 weeks (Part B)', 'description': 'Types and rates of adverse events'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Methylone', 'IMPACT-2', 'PTSD', 'Neuroplastogen', 'TSND-201'], 'conditions': ['Post Traumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': 'This study is evaluating the safety and efficacy of methylone in adults with PTSD. The study is conducted in two parts.\n\n* Part A is open-label and will enroll up to 15 participants with PTSD\n* Part B is randomized (1:1:1), single-blind and will enroll up to 45 participants with PTSD\n\nEligible participants will enter a 3-week Treatment Period (Part A) or 4-week Treatment Period (Part B) where they will receive methylone once weekly. Following the Treatment Period, participants will enter a 6-week Follow-up Period (Part A) or 8-week Follow-up Period (Part B).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meets DSM-5 criteria for severe PTSD diagnosis, with a symptom duration of at least 6 months.\n* Tried at least one treatment for PTSD (either psychotherapy or pharmacological treatment).\n* Proficient in reading and writing in local language sufficient to complete questionnaires.\n* Free from any other clinically significant illness or disease.\n\nExclusion Criteria:\n\n* Primary diagnosis of any other DSM-5 disorder.\n* Body mass index (BMI) \\<18kg/m2 or ≥40 kg/m2.\n* Smokes an average of \\>10 cigarettes and/or e-cigarettes per day.\n* Uncontrolled hypertension at Screening.\n* Use of prohibited concomitant medications or therapies.\n* Current or previous history of clinically significant cardiovascular/cerebrovascular conditions.'}, 'identificationModule': {'nctId': 'NCT06215261', 'acronym': 'IMPACT-2', 'briefTitle': 'An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Transcend Therapeutics'}, 'officialTitle': 'An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD IMPACT-2 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])', 'orgStudyIdInfo': {'id': 'TSND201-PTSD-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TSND-201 Low Dose', 'description': 'Part B only', 'interventionNames': ['Drug: Methylone']}, {'type': 'EXPERIMENTAL', 'label': 'TSND-201 Mid Dose', 'description': 'Part B only', 'interventionNames': ['Drug: Methylone']}, {'type': 'EXPERIMENTAL', 'label': 'TSND-201 High Dose', 'description': 'Part B only', 'interventionNames': ['Drug: Methylone']}], 'interventions': [{'name': 'Methylone', 'type': 'DRUG', 'description': 'Methylone capsules, given orally, once a week for 3 weeks (Part A) or 4 weeks (Part B)', 'armGroupLabels': ['TSND-201 High Dose', 'TSND-201 Low Dose', 'TSND-201 Mid Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33319', 'city': 'Lauderhill', 'state': 'Florida', 'country': 'United States', 'facility': 'Segal Trials', 'geoPoint': {'lat': 26.14036, 'lon': -80.21338}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Accel Research', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '32801', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'CNS Healthcare', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Uptown Clinical Research', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sunstone Medical', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '89119', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Redbird Research LLC', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '84020', 'city': 'Draper', 'state': 'Utah', 'country': 'United States', 'facility': 'Numinus', 'geoPoint': {'lat': 40.52467, 'lon': -111.86382}}, {'zip': '98004', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle NTC', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '3122', 'city': 'Hawthorn', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Swinburne University of Technology', 'geoPoint': {'lat': -37.81992, 'lon': 145.0358}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Ramsay Clinic Albert Road', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Monarch Mental Health Group', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Clerkenwell Health', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Transcend Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}