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Psychedelic

Psilocybin for Depression (PSI-RIS Trial)

Phase 2
Recruiting
Led By M. 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day -1) to visit 5 (day 7)
Awards & highlights

PSI-RIS Trial Summary

This trial tests if psilocybin's antidepressant effects depend on its psychedelic effects in people with treatment-resistant depression.

Who is the study for?
Adults aged 18-65 with treatment-resistant depression, defined as not responding to two or more antidepressants, can join this trial. They must be able to consent and communicate in English, have normal bloodwork, use effective contraception if applicable, and safely stop current medications affecting the study.Check my eligibility
What is being tested?
The trial is testing whether psilocybin's effects on depression require its psychedelic aspect by comparing three groups: one taking psilocybin with risperidone (which may block psychedelic effects), another taking psilocybin with a placebo, and a third group receiving placebo plus risperidone.See study design
What are the potential side effects?
Possible side effects include those related to psilocybin such as nausea, headache, increased heart rate or blood pressure changes; and for risperidone potential weight gain, fatigue or restlessness could occur.

PSI-RIS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day -1) to visit 5 (day 7)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day -1) to visit 5 (day 7) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of administering psilocybin (25mg) with risperidone (1mg)
Tolerability and safety of administering psilocybin (25mg) with risperidone (1mg)
Secondary outcome measures
Subjective psychedelic effects as measured by the 5-Dimensional Altered States of Consciousness (5D-ASC) Rating Scale
Other outcome measures
Change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from Baseline to 1-week post-treatment.

PSI-RIS Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Risperidone 1 mg plus Psilocybin 25 mgExperimental Treatment2 Interventions
Group II: Placebo plus Psilocybin 25 mgExperimental Treatment2 Interventions
Group III: Risperidone 1 mg plus PlaceboActive Control2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
356 Previous Clinical Trials
81,398 Total Patients Enrolled
85 Trials studying Depression
19,191 Patients Enrolled for Depression
M. Ishrat Husain, MBBS, MDPrincipal InvestigatorCentre for Addiction and Mental Health
M. Ishrat Husain, MBBS, MD (Res.)Principal InvestigatorCentre for Addiction and Mental Health

Media Library

Psilocybin (Psychedelic) Clinical Trial Eligibility Overview. Trial Name: NCT05710237 — Phase 2
Depression Research Study Groups: Risperidone 1 mg plus Psilocybin 25 mg, Placebo plus Psilocybin 25 mg, Risperidone 1 mg plus Placebo
Depression Clinical Trial 2023: Psilocybin Highlights & Side Effects. Trial Name: NCT05710237 — Phase 2
Psilocybin (Psychedelic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05710237 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential adverse effects should be anticipated when using Risperidone 1 mg and Psilocybin 25 mg together?

"The safety of Risperidone 1 mg plus Psilocybin 25 mg was rated a 2 out of 3 since this is currently classified as Phase 2 and there has been limited evidence to support efficacy, but some data supporting its safety."

Answered by AI

Is enrollment available for this investigative trial?

"The trial details hosted on clinicaltrials.gov demonstrate that this medical study is not recruiting patients at present. The investigation was first posted in February of 2023 and last updated Jan 24th, however there are 1279 other trials actively seeking participants now."

Answered by AI

Are late-adulthood participants being enrolled for this experiment?

"This study requires that people enrolling are aged 18 to 65. In addition, there is a total of 183 studies for minors and 960 research projects available for those over the age of majority."

Answered by AI

Is enrolment in this clinical research open to me?

"To qualify for the trial, participants must suffer from treatment-resistant depression and reside between 18 to 65 years of age. This clinical study is accepting a maximum of 60 patients."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I’ve been taking two antidepressants for several years. I have tried other antidepressants, but they do not seem to do any better. Two events have occurred in the past two years that have caused my depression to increase.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Does Psilocybin Require Psychedelic Effects to Treat Depression?
2023. "Does Psilocybin Require Psychedelic Effects to Treat Depression?". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05710237.
~40 spots leftby Feb 2026
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