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Psychedelic Therapy

Psilocybin for Depression (SYNVEST 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

Adults aged 18 to 65

Diagnosed with treatment-resistant depression

Must not have

Contraindications to psilocybin or risperidone

Disability preventing completion of study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to use PET imaging to see if the antidepressant effects of psilocybin in adults with treatment-resistant depression are linked to changes in synaptic density and the 5-HT2AR receptor

Who is the study for?

This trial is for adults with treatment-resistant depression, meaning standard treatments haven't worked for them. Participants should be in good physical health and not currently using psychoactive or hormonal medications.

What is being tested?

The study tests if psilocybin (from 'magic mushrooms') affects synaptic density in the brain differently when taken alone versus with risperidone, a medication that blocks some of its effects. It involves PET imaging to track changes.

What are the potential side effects?

Psilocybin can cause psychedelic experiences, emotional swings, nausea, and headaches. Risperidone may lead to weight gain, fatigue, dry mouth, restlessness and could potentially dampen psilocybin's effects.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 65 years old.

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My depression has not improved with treatment.

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I have been diagnosed with Major Depressive Disorder without psychosis.

Exclusion Criteria

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

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I am not allergic or unable to take psilocybin or risperidone.

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I have a disability that stops me from completing study tasks.

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I have a long QT interval or a history of Torsades de Pointes.

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I have had a traumatic brain injury or a neurological disorder.

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I have a blood or clotting disorder, or I use blood thinners.

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I cannot or do not want to have a PET or MRI scan.

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I have been diagnosed with a specific psychiatric disorder.

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I have not exceeded radiation exposure limits.

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

Feasibility of obtaining PET imaging scans before and after administration of psilocybin (25 mg) with and without risperidone (1 mg).

Secondary study objectives

Obtain preliminary data on synaptic density (as measured by [18F] SynVesT-1 volume distribution, VT) in brain regions relevant to MDD (i.e., hippocampus, prefrontal cortex)

Other study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Risperidone (1 mg) + Psilocybin (25 mg)Experimental Treatment2 Interventions

o One capsule of risperidone 1 mg will be taken first followed 60 minutes later by one capsule of psilocybin 25 mg. Both capsules will be taken orally with a glass of water.

Group II: Psilocybin (25 mg)Experimental Treatment1 Intervention

One capsule of psilocybin 25 mg will be taken orally with a glass of water.

0 / 11Eligibility criteria met