NCT03775200

Brief Summary

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

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
233

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2019

Geographic Reach
10 countries

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2021

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 24, 2023

Completed
Last Updated

April 24, 2023

Status Verified

April 1, 2023

Enrollment Period

2.4 years

First QC Date

December 11, 2018

Results QC Date

February 7, 2023

Last Update Submit

April 21, 2023

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (2)

  • Montgomery Asberg Depression Rating Scale (MADRS) Change From Baseline to Week 3

    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.

    Change from Baseline to Week 3

  • MADRS Change From Baseline to Week 3, Sensitivity Analysis

    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.

    Change from Baseline to Week 3

Study Arms (3)

Low dose

EXPERIMENTAL

Low dose Psilocybin

Drug: Psilocybin

Medium dose

EXPERIMENTAL

Medium dose Psilocybin

Drug: Psilocybin

High dose

EXPERIMENTAL

High dose Psilocybin

Drug: Psilocybin

Interventions

PsilocybinDRUG

Dose-finding

High doseLow doseMedium dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of TRD

You may not qualify if:

  • Other comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Kadima Neuropsychiatry Institute

La Jolla, California, 92037, United States

Location

Altman Clinical and Translational Research Institute, University of California

San Diego, California, 92093, United States

Location

Stanford Department of Psychiatry

Stanford, California, 94305, United States

Location

Mood and Anxiety Disorders Program Emory University School of Medicine

Atlanta, Georgia, 30329, United States

Location

Ray Worthy Psychiatry LLC

New Orleans, Louisiana, 70123, United States

Location

Sheppard Pratt Health System

Baltimore, Maryland, 21204, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

UT Center of Excellence on Mood Disorders, University of Texas Health Science Center

Houston, Texas, 77054, United States

Location

Canadian Rapid Treatment Centre of Excellence

Mississauga, Ontario, Canada

Location

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Location

National Institute of Mental Health Czech Republic

Klecany, Czechia

Location

Enhed for Psykiatrisk Forskning, Psykiatrien i Aalborg

Aalborg, Denmark

Location

Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Tallaght University Hospital

Dublin, Ireland

Location

Groningen University Medical Centre

Groningen, Netherlands

Location

Leiden University Medical Centre

Leiden, Netherlands

Location

Utrecht University Medical Centre

Utrecht, Netherlands

Location

Unidade de Neuropsiquiatria, Centro Clinico Champalimaud

Lisbon, Portugal

Location

Hospital de Dia Numancia

Barcelona, Spain

Location

Institute Hospital del Mar of Medical Research (IMIM)

Barcelona, Spain

Location

Clinical Research and Imaging Centre

Bristol, Avon, United Kingdom

Location

Wolfson Research Centre, Campus for Ageing and Vitality

Newcastle upon Tyne, Tyne and Wear, NE4 5PL, United Kingdom

Location

St. Pancras Clinical Research

London, EC2Y 8EA, United Kingdom

Location

Kings College London, Institute of Psychiatry, Psychology and Neurology

London, United Kingdom

Location

Greater Manchester Mental Health Foundation Trust

Manchester, United Kingdom

Location

Related Publications (3)

  • Kirlic N, Atli M, Mistry S, Gold M, Goodwin GM. The Relationship Between Participant Pretreatment Clinical Presentation and the Quality of Psilocybin Experience: A Retrospective Analysis. J Clin Psychopharmacol. 2025 Dec 9. doi: 10.1097/JCP.0000000000002119. Online ahead of print.

    PMID: 41362124DERIVED

  • 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.

    PMID: 36322843DERIVED

  • 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.

    PMID: 31543078DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Indole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTryptaminesIndolizidinesIndolizines

Results Point of Contact

Title
Medical Director
Organization
Compass Pathways
info@compasspathways.com
07443136539

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2018

First Posted

December 13, 2018

Study Start

March 1, 2019

Primary Completion

July 30, 2021

Study Completion

September 27, 2021

Last Updated

April 24, 2023

Results First Posted

April 24, 2023

Record last verified: 2023-04

Locations

IE(1)DE(1)US(8)GB(5)CA(2)NL(3)CZ(1)DK(1)PT(1)ES(2)