NCT05029466

Psilocybin for Treatment-Resistant Depression

The Efficacy and Tolerability of Psilocybin in Participants With Treatment-Resistant Depression: a Phase 2, Randomized Feasibility Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Brain and Cognition Discovery Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This randomized clinical trial will assess the feasibility, safety, and efficacy of single and repeat doses of psilocybin at point-of-care in persons with treatment-resistant depression as part of major depressive disorder or bipolar II disorder. The primary objective is to evaluate the feasibility of psilocybin in adults with treatment-resistant depression. The secondary objectives are to assess the efficacy and tolerability of psilocybin at point-of-care.

Conditions

• Treatment Resistant Depression

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-11-19
• Primary completion: 2023-07-22
• Completion: 2023-07-22
• First posted: 2021-08-31
• Last updated: 2023-07-27

Locations

1 site across 1 country: Canada