Actively Recruiting
Treatment With Psilocybin for Chronic Neuropathic Pain and Depression (TRANSCEND)
Led by Centre for Addiction and Mental Health · Updated on 2025-04-25
16
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Treatment With Psilocybin for Chronic Neuropathic Pain and Depression (TRANSCEND)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 to 65 years old
- Outpatients
- Ability to provide informed consent
- Signed informed consent form
- Willingness to follow all study procedures
- Ability to read and communicate in English
- Primary diagnosis of non-psychotic major depressive disorder (MDD) confirmed by SCID-5
- Treatment-resistant depression with a baseline HamD-17 score >14 and failure to respond to two or more antidepressant trials
- Diagnosis of chronic neuropathic pain confirmed by a pain specialist and LANSS questionnaire
- Moderate-to-severe neuropathic pain with PROMIS Pain Interference score >60 and mean pain intensity >5 on numeric scale
- Previous trials of at least two neuropathic pain medications without meaningful symptom improvement
- Ability to take oral medication
- Estimated glomerular filtration rate (eGFR) above 40 mL/min/1.73m2 and clinically acceptable blood work
- Use of highly effective contraception for those capable of becoming pregnant prior to and during study
- Willingness to taper off current antidepressants and antipsychotics for at least 2 weeks before baseline and during the study with physician approval
- Agreement to follow lifestyle considerations throughout the study
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during the study
- Treatment with another investigational drug or intervention within 30 days before screening
- Started psychotherapy within 12 weeks before screening
- Substance use disorder diagnosis within past 6 months (except tobacco, alcohol, cannabis, prescribed opioids)
- Active suicidal ideation with intent and plan
- Lifetime diagnosis of schizophrenia-spectrum, bipolar I or II, psychotic disorder, obsessive-compulsive disorder, paranoid personality disorder, borderline personality disorder, or neurocognitive disorder
- First-degree relative with schizophrenia-spectrum, bipolar I or II, or psychotic disorder
- Contraindications to psilocybin including drug allergy, recent stroke, uncontrolled hypertension, recent heart attack, severe coronary artery disease, or moderate to severe kidney or liver problems
- Prolonged QTc or history of long QTc syndrome or related risks
- Current use of methadone, buprenorphine, or high-dose morphine (>100 mg or equivalent)
- Other serious physical illnesses that may interfere with study or pose health risks per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M6J1H4
Actively Recruiting
Research Team
M
Muhammad Ishrat Husain, MBBS, MD
CONTACT
A
Alexandria Coles, MSc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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