NCT06518720

Treatment With Psilocybin for Chronic Neuropathic Pain and Depression (TRANSCEND)

Treatment With Psilocybin for Chronic Neuropathic Pain and Depression (TRANSCEND): An Open-Label Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Centre for Addiction and Mental Health · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. The purpose of this study is to assess the feasibility, tolerability, and preliminary efficacy of psilocybin therapy for adults with chronic neuropathic pain and co-morbid treatment resistant depression.

Conditions

• Treatment Resistant Depression
• Chronic Pain

Interventions

Type	Name	Description
DRUG	Psilocybin 25 mg	The psilocybin used in this study meets quality specifications suitable for human research use. The active drug is encapsulated using a hydroxypropyl methylcellulose (HPMC) capsule and contains 25 mg of psilocybin. The psilocybin will be administered once during the trial in combination with supportive therapy.

Timeline

• Start date: 2025-04-01
• Primary completion: 2027-03-01
• Completion: 2027-12-01
• First posted: 2024-07-24
• Last updated: 2025-04-25

Locations

1 site across 1 country: Canada