Clinical TrialTreatment-Resistant Depression (TRD)PsilocybinPsilocybinPsilocybinCompleted

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

The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression – a dose-ranging study.

Target Enrollment
233 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomized, parallel-group, quadruple-blind, dose-ranging Phase II trial of psilocybin for treatment-resistant depression with three experimental dose arms (low, medium, high); psychotherapy provided alongside dosing.

Multi-centre study (sites in the United States, Canada and several European countries) assessing safety and efficacy outcomes in adults with TRD; actual enrolment reported as 233.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Low dose

experimental

Low dose Psilocybin.

Interventions

  • Psilocybin
    via Oral• single dose

    Dose-finding, low dose arm per protocol.

Medium dose

experimental

Medium dose Psilocybin.

Interventions

  • Psilocybin
    via Oral• single dose

    Dose-finding, medium dose arm per protocol.

High dose

experimental

High dose Psilocybin.

Interventions

  • Psilocybin
    via Oral• single dose

    Dose-finding, high dose arm per protocol.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Diagnosis of treatment-resistant depression (TRD).

Exclusion Criteria

  • Exclusion Criteria:
  • Other comorbidities (per protocol).

Study Details

Locations

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

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