The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression
NCT ID: NCT03775200
Last Updated: 2023-04-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
233 participants
INTERVENTIONAL
2019-03-01
2021-09-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low dose
Low dose Psilocybin
Psilocybin
Dose-finding
Medium dose
Medium dose Psilocybin
Psilocybin
Dose-finding
High dose
High dose Psilocybin
Psilocybin
Dose-finding
Interventions
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Psilocybin
Dose-finding
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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COMPASS Pathways
INDUSTRY
Responsible Party
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Locations
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Kadima Neuropsychiatry Institute
La Jolla, California, United States
Altman Clinical and Translational Research Institute, University of California
San Diego, California, United States
Stanford Department of Psychiatry
Stanford, California, United States
Mood and Anxiety Disorders Program Emory University School of Medicine
Atlanta, Georgia, United States
Ray Worthy Psychiatry LLC
New Orleans, Louisiana, United States
Sheppard Pratt Health System
Baltimore, Maryland, United States
New York State Psychiatric Institute
New York, New York, United States
UT Center of Excellence on Mood Disorders, University of Texas Health Science Center
Houston, Texas, United States
Canadian Rapid Treatment Centre of Excellence
Mississauga, Ontario, Canada
Centre for Addiction and Mental Health
Toronto, Ontario, Canada
National Institute of Mental Health Czech Republic
Klecany, , Czechia
Enhed for Psykiatrisk Forskning, Psykiatrien i Aalborg
Aalborg, , Denmark
Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin
Berlin, , Germany
Tallaght University Hospital
Dublin, , Ireland
Groningen University Medical Centre
Groningen, , Netherlands
Leiden University Medical Centre
Leiden, , Netherlands
Utrecht University Medical Centre
Utrecht, , Netherlands
Unidade de Neuropsiquiatria, Centro Clinico Champalimaud
Lisbon, , Portugal
Hospital de Dia Numancia
Barcelona, , Spain
Institute Hospital del Mar of Medical Research (IMIM)
Barcelona, , Spain
Clinical Research and Imaging Centre
Bristol, Avon, United Kingdom
Wolfson Research Centre, Campus for Ageing and Vitality
Newcastle upon Tyne, Tyne and Wear, United Kingdom
St. Pancras Clinical Research
London, , United Kingdom
Kings College London, Institute of Psychiatry, Psychology and Neurology
London, , United Kingdom
Greater Manchester Mental Health Foundation Trust
Manchester, , United Kingdom
Countries
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References
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Goodwin GM, Aaronson ST, Alvarez O, Arden PC, Baker A, Bennett JC, Bird C, Blom RE, Brennan C, Brusch D, Burke L, Campbell-Coker K, Carhart-Harris R, Cattell J, Daniel A, DeBattista C, Dunlop BW, Eisen K, Feifel D, Forbes M, Haumann HM, Hellerstein DJ, Hoppe AI, Husain MI, Jelen LA, Kamphuis J, Kawasaki J, Kelly JR, Key RE, Kishon R, Knatz Peck S, Knight G, Koolen MHB, Lean M, Licht RW, Maples-Keller JL, Mars J, Marwood L, McElhiney MC, Miller TL, Mirow A, Mistry S, Mletzko-Crowe T, Modlin LN, Nielsen RE, Nielson EM, Offerhaus SR, O'Keane V, Palenicek T, Printz D, Rademaker MC, van Reemst A, Reinholdt F, Repantis D, Rucker J, Rudow S, Ruffell S, Rush AJ, Schoevers RA, Seynaeve M, Shao S, Soares JC, Somers M, Stansfield SC, Sterling D, Strockis A, Tsai J, Visser L, Wahba M, Williams S, Young AH, Ywema P, Zisook S, Malievskaia E. 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.
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. Epub 2019 Sep 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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COMP001
Identifier Type: -
Identifier Source: org_study_id
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