MedTrace Logo

Psilocybin for Treatment-Resistant Depression

NCT05029466 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-07-27

No results posted yet for this study

Summary

The purpose of this study is to see if psilocybin, an investigational drug, is safe and well tolerated. Researchers also want to know if psilocybin can improve symptoms of depression. This study will see if psilocybin is safe and well tolerated by tracking changes in suicidal thoughts and behaviour, monitoring if any participants choose to stop participating in the study, and measuring any serious side effects, as well as how long they take to resolve. This study will also see if depression symptoms improve (or worsen) after psilocybin is administered. Additional information about participants' depressive symptoms and side effects will also be measured during the study.

Conditions

Interventions

DRUG

Psilocybin

Participants will receive a single dose of psilocybin and be assessed weekly for six weeks and biweekly for 18 weeks. Participants who relapse may receive up to two repeated doses of psilocybin.

Sponsors & Collaborators

  • Braxia Scientific Corp.

    collaborator UNKNOWN

  • Usona Institute

    collaborator OTHER

  • Brain and Cognition Discovery Foundation

    lead OTHER

Principal Investigators

  • Joshua D Rosenblat, MD, MSc · Canadian Rapid Treatment Centre of Excellence

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-19
Primary Completion
2023-07-22
Completion
2023-07-22

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT05029466 on ClinicalTrials.gov