Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-02 @ 8:31 AM
Study NCT ID:
NCT05624268
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2022-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy, Safety, and Tolerability of COMP360 in Participants With 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 255}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2022-11-14', 'studyFirstSubmitQcDate': '2022-11-14', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COMP360 25 mg versus placebo for the change from baseline in MADRS total score', 'timeFrame': 'Week 6', 'description': 'Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity'}], 'secondaryOutcomes': [{'measure': 'COMP360 25 mg versus placebo for the change from baseline in SDS total score', 'timeFrame': 'Week 6', 'description': 'Sheehan Disability Scale (SDS) is a brief, five-item self report inventory that assesses functional impairment in work/school, social life, and family life.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Treatment Resistant Depression']}, 'descriptionModule': {'briefSummary': 'Efficacy, Safety, and Tolerability of a single administration of COMP360 in participants with treatment-resistant depression (TRD)', 'detailedDescription': 'This is a phase III, international, multi-centre, randomised, parallel group, fixed single-dose, double-blind, placebo-controlled study. The study population will include participants aged ≥18 years with TRD.\n\nOverall, 255 participants will be randomised in a 2:1 ratio to receive COMP360 25 mg or placebo.\n\nThe study comprises three parts (A, B, and C) and will last approximately 62 weeks including a three- to ten-week Screening Period.\n\nPart A will include a six-week follow-up from initial investigational product (IP) administration.\n\nIn this study, the primary aim is to assess the efficacy and safety of a single dose of COMP360 25 mg versus placebo for reducing symptom severity in TRD, when administered with psychological support. This will be assessed in a 6-week, single-dose, double-blind, placebo-controlled part of the study (Part A). Durability of efficacy and long-term safety, and the efficacy and safety of re-treatment will be assessed in a 20-week single-dose, double-blind re-treatment part (Part B), and a 26-week open-label treatment part (Part C).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Aged ≥18 years at Screening\n2. Major depression without psychotic features (single or recurrent episode as informed by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition \\[DSM-5\\])\n3. If the current major depressive episode is the participant's first lifetime episode of depression, the length of the current episode must be ≥3 months and ≤2 years at Screening\n4. MADRS total score ≥20 at Screening and Baseline to ensure at least moderate severity of depression\n5. TRD, defined as failure to respond to an adequate dose and duration of two, three, or four different pharmacological treatments for the current episode as determined through the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ) and using the supplementary advice on additional antidepressants not included in MGH-ATRQ.\n6. At Screening, agreement to discontinue all prohibited medications.\n\nKey Exclusion Criteria:\n\nPsychiatric Exclusion Criteria:\n\n1. Prior or ongoing bipolar disorder, any psychotic disorder, including schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder (unless substance induced or due to a medical condition), antisocial personality disorder as assessed by a structured clinical interview (MINI 7.0.2)\n2. Lifetime paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder, or any ongoing serious psychiatric comorbidity based on medical history and clinical judgement\n3. Borderline personality disorder as demonstrated by medical history or the Mini International Neuropsychiatric Interview Plus (MINI plus) - borderline personality disorder module\n4. Ongoing post-traumatic stress disorder, obsessive-compulsive disorder, or anorexia nervosa as assessed by medical history and a structured clinical interview (MINI 7.0.2)\n5. Psychiatric inpatient within the past 12 months prior to Screening\n6. Use of electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation during the current depressive episode\n7. Transcranial magnetic stimulation within the past six months prior to Screening\n8. Current enrolment in a psychological therapy programme that will not remain stable for the duration of the study. Psychological therapies cannot have been initiated within 30 days prior to Screening\n9. Exposure to COMP360 psilocybin therapy prior to Screening"}, 'identificationModule': {'nctId': 'NCT05624268', 'briefTitle': 'Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD', 'organization': {'class': 'INDUSTRY', 'fullName': 'COMPASS Pathways'}, 'officialTitle': 'A Phase III, Multicentre, Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, and Tolerability of COMP360 in Participants With Treatment-resistant Depression', 'orgStudyIdInfo': {'id': 'COMP 005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '25 mg COMP360 Psilocybin', 'description': '25 mg COMP360 Psilocybin', 'interventionNames': ['Drug: Psilocybin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matched placebo', 'interventionNames': ['Drug: Psilocybin']}], 'interventions': [{'name': 'Psilocybin', 'type': 'DRUG', 'otherNames': ['COMP360'], 'description': 'COMP360 Psilocybin administered under supportive conditions', 'armGroupLabels': ['25 mg COMP360 Psilocybin', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona College of Medicine - Tuscon', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90230', 'city': 'Culver City', 'state': 'California', 'country': 'United States', 'facility': 'ProScience Research Group', 'geoPoint': {'lat': 34.02112, 'lon': -118.39647}}, {'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Network, LLC', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Kadima Neuropsychiatry Institute', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University California San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90004', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'California Center for Psychedelic Therapy', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'CalNeuro Research Group, Inc', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90064', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Clarity Clinical Research, LLC', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'ATP Clinical Research, Inc.', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Artemis Institute for Clinical Research', 'geoPoint': {'lat': 32.71571, 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'Florida', 'country': 'United States', 'facility': 'APG Research, LLC', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33782', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'DMI Health Care Group, Inc', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33803', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Meridien Research/Accel Research', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30060', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Psych Atlanta', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30329-2209', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Uptown Research Institute, LLC', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21044', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sheppard Pratt Health System', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20877', 'city': 'Gaithersburg', 'state': 'Maryland', 'country': 'United States', 'facility': 'CBH Health, LLC', 'geoPoint': {'lat': 39.14344, 'lon': -77.20137}}, {'zip': '21208', 'city': 'Pikesville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Pharmasite Research, Inc', 'geoPoint': {'lat': 39.37427, 'lon': -76.72247}}, {'zip': '01655', 'city': 'North Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Medical School', 'geoPoint': {'lat': 42.31676, 'lon': -71.81757}}, {'zip': '55416', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '63304', 'city': 'Saint Charles', 'state': 'Missouri', 'country': 'United States', 'facility': 'Midwest Research Group', 'geoPoint': {'lat': 38.78394, 'lon': -90.48123}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68526', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Alivation Research, LLC.', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '08755', 'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Bio Behavioral Health', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York State Psychiatric Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10128', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'The Medical Research Network, LLC', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44122', 'city': 'Beachwood', 'state': 'Ohio', 'country': 'United States', 'facility': 'Insight Clinical Trials, LLC', 'geoPoint': {'lat': 41.4645, 'lon': -81.50873}}, {'zip': '44720', 'city': 'North Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Neuro-Behaviroral Clinical Research, Inc.', 'geoPoint': {'lat': 40.87589, 'lon': -81.40234}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Rivus Wellness & Research Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '18507', 'city': 'Moosic', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Global Medical Institutes, LLC, Scranton Medical Institute', 'geoPoint': {'lat': 41.35341, 'lon': -75.73825}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Health Science Center at Houston (UTHSC-H)', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84020', 'city': 'Draper', 'state': 'Utah', 'country': 'United States', 'facility': 'Cedar Clinical Research', 'geoPoint': {'lat': 40.52467, 'lon': -111.86382}}, {'zip': '98201', 'city': 'Everett', 'state': 'Washington', 'country': 'United States', 'facility': 'Core Clinical Research', 'geoPoint': {'lat': 47.97898, 'lon': -122.20208}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'COMPASS Pathways', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}