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Ignite Creation Date: 2025-12-26 @ 12:19 PM

Ignite Modification Date: 2026-03-05 @ 10:10 PM

Study NCT ID: NCT03775200

Status: COMPLETED

Last Update Posted: 2023-04-24

First Post: 2018-12-11

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}}}}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@compasspathways.com', 'phone': '07443136539', 'title': 'Medical Director', 'organization': 'Compass Pathways'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 Weeks', 'description': 'The Safety Analysis Set included all randomised participants who received study drug.', 'eventGroups': [{'id': 'EG000', 'title': '25 mg COMP360 Psilocybin', 'description': '25 mg COMP360 Psilocybin', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 60, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': '10 mg COMP360 Psilocybin', 'description': '10 mg COMP360 Psilocybin', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 51, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': '1 mg COMP360 Psilocybin', 'description': '1 mg COMP360 Psilocybin', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 50, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 34, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 22, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 30, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Euphoric mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Mood altered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Panic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Thinking abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Drug withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Suicidal behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Intentional self-injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Adjustment disorder with anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Adjustment disorder with mixed anxiety and depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Montgomery Asberg Depression Rating Scale (MADRS) Change From Baseline to Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '25 mg COMP360 Psilocybin', 'description': '25 mg COMP360 Psilocybin'}, {'id': 'OG001', 'title': '10 mg COMP360 Psilocybin', 'description': '10 mg COMP360 Psilocybin'}, {'id': 'OG002', 'title': '1 mg COMP360 Psilocybin', 'description': '1 mg COMP360 Psilocybin'}], 'classes': [{'categories': [{'measurements': [{'value': '-12', 'spread': '12.98', 'groupId': 'OG000'}, {'value': '-8.9', 'spread': '10.94', 'groupId': 'OG001'}, {'value': '-6.8', 'spread': '11.10', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Mean Square Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.6', 'ciLowerLimit': '-10.2', 'ciUpperLimit': '-2.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.86', 'estimateComment': 'LSM difference of COMP360 25 mg compared to COMP360 1 mg.', 'groupDescription': 'The primary analysis was the comparison between COMP360 (25 mg or 10 mg) versus COMP360 1 mg. The null hypothesis was that there was no difference in mean change from Baseline in MADRS total score at Week 3 for COMP360 25 mg or COMP360 10 mg versus COMP360 1 mg. The alternative hypothesis was that were was a difference in mean change from Baseline in MADRS total score at Week 3 for COMP360 25 mg or COMP360 10 mg versus COMP360 1 mg.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Hypothetical strategy estimand - missing not at random (MNAR) and missing at random (MAR) imputation for missing data.', 'nonInferiorityComment': 'For this primary analysis, a sample size of 216 randomised participants (72:72:72) will provide 90% power at the alpha = 0.05 level to detect a 6-point difference in average MADRS total score between the optimal therapeutic dose of COMP360 and COMP360 1 mg, assuming the common standard deviation (SD) is 11.0.'}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 3', 'description': 'MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response \\>= 50% decrease and remission \\<= 10 total score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set includes all participants randomised who receive study drug and have at least 1 post-dose efficacy assessment.'}, {'type': 'PRIMARY', 'title': 'MADRS Change From Baseline to Week 3, Sensitivity Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '25 mg COMP360 Psilocybin', 'description': '25 mg COMP360 Psilocybin'}, {'id': 'OG001', 'title': '10 mg COMP360 Psilocybin', 'description': '10 mg COMP360 Psilocybin'}, {'id': 'OG002', 'title': '1 mg COMP360 Psilocybin', 'description': '1 mg COMP360 Psilocybin'}], 'classes': [{'categories': [{'measurements': [{'value': '-12', 'spread': '12.98', 'groupId': 'OG000'}, {'value': '-8.9', 'spread': '11.11', 'groupId': 'OG001'}, {'value': '-6.7', 'spread': '11.18', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Mean Square Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.6', 'ciLowerLimit': '-9.4', 'ciUpperLimit': '-1.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.93', 'groupDescription': 'Sensitivity analysis of the primary endpoint using the per-protocol analysis set.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Hypothetical strategy estimand - MNAR and MAR imputation for missing data.'}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 3', 'description': 'MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response \\>= 50% decrease and remission \\<= 10 total score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The per-protocol analysis set includes all participants in the Full Analysis Set who do not have a protocol deviation that is thought to significantly affect the integrity of the participant's efficacy data."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '25 mg COMP360 Psilocybin', 'description': '25 mg COMP360 Psilocybin'}, {'id': 'FG001', 'title': '10 mg COMP360 Psilocybin', 'description': '10 mg COMP360 Psilocybin'}, {'id': 'FG002', 'title': '1 mg COMP360 Psilocybin', 'description': '1 mg COMP360 Psilocybin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '79'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '69'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}]}]}], 'recruitmentDetails': 'First patient first visit: 1 March 2019 Last patients last visit: 27 September 2021'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '233', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '25 mg COMP360 Psilocybin', 'description': '25 mg COMP360 Psilocybin'}, {'id': 'BG001', 'title': '10 mg COMP360 Psilocybin', 'description': '10 mg COMP360 Psilocybin'}, {'id': 'BG002', 'title': '1 mg COMP360 Psilocybin', 'description': '1 mg COMP360 Psilocybin'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '226', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.2', 'spread': '12.19', 'groupId': 'BG000'}, {'value': '40.6', 'spread': '12.76', 'groupId': 'BG001'}, {'value': '38.7', 'spread': '11.71', 'groupId': 'BG002'}, {'value': '39.8', 'spread': '12.19', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Age at Screening', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '112', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '215', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Ireland', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}]}, {'title': 'Portugal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': 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Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. N Engl J Med. 2022 Nov 3;387(18):1637-1648. doi: 10.1056/NEJMoa2206443."}, {'pmid': '31543078', 'type': 'DERIVED', 'citation': "Kelly JR, Baker A, Babiker M, Burke L, Brennan C, O'Keane V. The psychedelic renaissance: the next trip for psychiatry? Ir J Psychol Med. 2022 Dec;39(4):335-339. doi: 10.1017/ipm.2019.39. 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