Clinical trial NCT03775200: The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression
Official title: The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Treatment Resistant Depression
Lead sponsor: COMPASS Pathways
Sponsor class: INDUSTRY
First posted: 2018-12-13
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression

Detailed description: The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression - a dose-ranging study

Eligibility criteria: Inclusion Criteria:

* Diagnosis of TRD

Exclusion Criteria:

* Other comorbidities

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale (MADRS) Change From Baseline to Week 3
timeFrame: Change from Baseline to Week 3
measure: MADRS Change From Baseline to Week 3, Sensitivity Analysis
timeFrame: Change from Baseline to Week 3
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Kadima Neuropsychiatry Institute
state: California
city: San Diego
country: United States
facility: Altman Clinical and Translational Research Institute, University of California
state: California
city: Stanford
country: United States
facility: Stanford Department of Psychiatry
state: California
city: Atlanta
country: United States
facility: Mood and Anxiety Disorders Program Emory University School of Medicine
state: Georgia
city: New Orleans
country: United States
facility: Ray Worthy Psychiatry LLC
state: Louisiana
city: Baltimore
country: United States
facility: Sheppard Pratt Health System
state: Maryland
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
city: Houston
country: United States
facility: UT Center of Excellence on Mood Disorders, University of Texas Health Science Center
state: Texas
city: Mississauga
country: Canada
facility: Canadian Rapid Treatment Centre of Excellence
state: Ontario
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
city: Klecany
country: Czechia
facility: National Institute of Mental Health Czech Republic
city: Aalborg
country: Denmark
facility: Enhed for Psykiatrisk Forskning, Psykiatrien i Aalborg
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin
city: Dublin
country: Ireland
facility: Tallaght University Hospital
city: Groningen
country: Netherlands
facility: Groningen University Medical Centre
city: Leiden
country: Netherlands
facility: Leiden University Medical Centre
city: Utrecht
country: Netherlands
facility: Utrecht University Medical Centre
city: Lisboa
country: Portugal
facility: Unidade de Neuropsiquiatria, Centro Clinico Champalimaud
city: Barcelona
country: Spain
facility: Hospital de Dia Numancia
city: Barcelona
country: Spain
facility: Institute Hospital del Mar of Medical Research (IMIM)
city: Bristol
country: United Kingdom
facility: Clinical Research and Imaging Centre
state: Avon
city: Newcastle Upon Tyne
country: United Kingdom
facility: Wolfson Research Centre, Campus for Ageing and Vitality
state: Tyne And Wear
city: London
country: United Kingdom
facility: St. Pancras Clinical Research
city: London
country: United Kingdom
facility: Kings College London, Institute of Psychiatry, Psychology and Neurology
city: Manchester
country: United Kingdom
facility: Greater Manchester Mental Health Foundation Trust
Study officials:
References:
citation: 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.