Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-01-01 @ 3:01 PM
Study NCT ID:
NCT04433858
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-09
First Post:
2020-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061218', 'term': 'Depressive Disorder, Treatment-Resistant'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011562', 'term': 'Psilocybin'}], 'ancestors': [{'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-07', 'studyFirstSubmitDate': '2020-06-13', 'studyFirstSubmitQcDate': '2020-06-13', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Montgomery Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'From Baseline (Day -1) to three weeks post-dose.', 'description': 'MADRS is a clinician-rated scale measuring depression severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of 60; higher scores denote greater severity. Response = \\>50% decrease and Remission =\\< 10 actual score.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Treatment Resistant Depression']}, 'referencesModule': {'references': [{'pmid': '40499827', 'type': 'DERIVED', 'citation': 'Ellis S, Bostian C, Donnelly A, Feng W, Eisen K, Lean M, Conlan E, Ostacher M, Aaronson S, Suppes T. Long-term outcomes of single-dose psilocybin for U.S. military Veterans with severe treatment-resistant depression - 12-month data from an open-label pilot study. J Affect Disord. 2025 Nov 15;389:119655. doi: 10.1016/j.jad.2025.119655. Epub 2025 Jun 9.'}, {'pmid': '39343309', 'type': 'DERIVED', 'citation': 'Ellis S, Bostian C, Feng W, Fischer E, Schwartz G, Eisen K, Lean M, Conlan E, Ostacher M, Aaronson S, Suppes T. Single-dose psilocybin for U.S. military Veterans with severe treatment-resistant depression - A first-in-kind open-label pilot study. J Affect Disord. 2025 Jan 15;369:381-389. doi: 10.1016/j.jad.2024.09.133. Epub 2024 Sep 27.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the efficacy of psilocybin (25 mg) administered under supportive conditions to adult participants with severe TRD, in improving depressive symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of at least moderate Major Depressive Disorder (MDD)\n\nExclusion Criteria:\n\n* Comorbidities\n\nNote for CA site: Only Veterans are Eligible'}, 'identificationModule': {'nctId': 'NCT04433858', 'briefTitle': 'An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)', 'organization': {'class': 'OTHER', 'fullName': 'Sheppard Pratt Health System'}, 'officialTitle': 'An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)', 'orgStudyIdInfo': {'id': '14947563'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Psilocybin', 'description': '25mg of Psilocybin\n\nNote: CA site only is re-dosing participants with an exacerbation in depressive symptoms at a minimum of 12 months post-initial dosing.', 'interventionNames': ['Drug: Psilocybin']}], 'interventions': [{'name': 'Psilocybin', 'type': 'DRUG', 'otherNames': ['COMP360'], 'description': 'open-label', 'armGroupLabels': ['Psilocybin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'VA Palo Alto Healthcare System/Stanford Medicine', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '21204', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sheppard Pratt Health System', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Scott Aaronson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheppard Pratt Health System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheppard Pratt Health System', 'class': 'OTHER'}, 'collaborators': [{'name': 'COMPASS Pathways', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Clinical Research Programs', 'investigatorFullName': 'Scott T. Aaronson, M.D', 'investigatorAffiliation': 'Sheppard Pratt Health System'}}}}