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Psilocybin in Depression Resistant to Standard Treatments

NCT04959253 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-07-22

No results posted yet for this study

Summary

A single centre clinical trial to evaluate the feasibility, safety and efficacy of psilocybin, given under supportive conditions, in a randomised, blinded design in adult participants with treatment resistant major depressive disorder. The primary objective is to evaluate feasibility by measuring recruitment rates, dropout rates and by estimating the variance of the primary outcome measure (MADRS).

Conditions

Interventions

COMBINATION_PRODUCT

Psilocybin assisted therapy

A package of psychological therapy and a single dosing session of psilocybin.

COMBINATION_PRODUCT

Placebo assisted therapy

A package of psychological therapy and a single dosing session of placebo.

Sponsors & Collaborators

Principal Investigators

  • James Rucker, MD PhD · King's College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2023-09-01
Completion
2023-11-01

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04959253 on ClinicalTrials.gov