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Psychedelic Therapy

Psilocybin for Chronic Pain and Depression (TRANSCEND Trial)

Phase 2

Waitlist Available

Led By Muhammad Ishrat Husain, MBBS, MD

Research Sponsored by Centre for Addiction and Mental Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have a primary DSM-5 diagnosis of non-psychotic Major Depressive Disorder (MDD)

Must have a diagnosis of chronic neuropathic pain confirmed by a pain specialist

Must not have

Relative or absolute contraindications to psilocybin

Presence of specific cardiac conditions or risk factors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if using psilocybin, found in 'magic mushrooms', along with therapy can help adults with chronic nerve pain and depression that doesn't respond well to treatment. Previous studies

Who is the study for?

This trial is for adults with chronic nerve pain and depression that hasn't improved with standard treatments. Participants must be able to undergo psychotherapy sessions and take psilocybin safely.

What is being tested?

The study tests the effects of a single dose of Psilocybin (25 mg), combined with psychotherapy, on individuals suffering from long-term neuropathic pain and depression resistant to usual treatments.

What are the potential side effects?

Psilocybin can cause headaches, nausea, dizziness, changes in perception or mood swings during treatment. Long-term side effects are still being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with major depression without psychosis.

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My chronic pain has been confirmed as neuropathic by a specialist.

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I can take pills by mouth.

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My kidney function and blood work meet the required levels.

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I am between 18 and 65 years old and not hospitalized.

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I experience significant nerve pain.

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I have tried at least two medications for nerve pain without success.

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My depression hasn't improved with standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take psilocybin due to health risks.

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I have certain heart conditions or risks.

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I have been diagnosed with a psychiatric disorder defined in the DSM-5.

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I am currently taking certain medications.

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I have a history of heart rhythm problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of participants recruited, enrolled and retained (feasibility) and the number of serious adverse events and serious adverse drug reactions associated with administration of 25 mg of psilocybin (safety).

Secondary study objectives

Change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from Baseline to 1-week post-treatment.

Other study objectives

Change in Patient Reported Outcomes Measurement Information System- Pain Interference Scale (PROMIS-Interference) from Baseline to 1-week post-treatment.

Change in Patient Reported Outcomes Measurement Information System-Pain Intensity Scale (PROMIS-PI) from Baseline to 1-week post-treatment.