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Psychedelic Therapy

Psilocybin-Assisted Psychotherapy for Depression (PSI-1V2 Trial)

Phase 2
Recruiting
Led By Joshua Rosenblat, MD, MSc
Research Sponsored by University Health Network, Toronto
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 to 6 month follow-up

Summary

This trial will test if one or two doses of psilocybin can help patients with treatment-resistant depression. It will investigate which dosing is more effective in relieving depressive symptoms and if a second

Who is the study for?
This trial is for individuals with treatment-resistant depression, meaning they haven't responded well to standard treatments. Participants must be adults who can safely receive psilocybin and are willing to undergo psychotherapy sessions.
What is being tested?
The study is testing the effectiveness of one versus two doses of psilocybin in conjunction with psychotherapy on relieving symptoms of depression. It aims to determine which dosage level improves quality of life and cognitive functions more effectively.
What are the potential side effects?
Possible side effects from psilocybin may include headaches, nausea, dizziness, changes in perception or mood swings during the session. Long-term side effects are being studied as part of this trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Antidepressant Efficacy
Secondary study objectives
Anxiety Symptoms
Cognitive Dysfunction
Effort-Based Decision Making
+9 more
Other study objectives
EEG Predictors of Response
Expectancy Effects
Participant Blinding Success
+3 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Two Doses of PsilocybinActive Control1 Intervention
Two psychedelic doses (25mg of psilocybin + 25mg of psilocybin) taken in conjunction with psilocybin-assisted psychotherapy
Group II: Single Dose of PsilocybinPlacebo Group1 Intervention
One psychedelic dose (1mg of psilocybin + 25mg of psilocybin) taken in conjunction with psilocybin-assisted psychotherapy

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,521 Previous Clinical Trials
503,212 Total Patients Enrolled
55 Trials studying Depression
11,255 Patients Enrolled for Depression
Centre for Addiction and Mental HealthOTHER
371 Previous Clinical Trials
83,217 Total Patients Enrolled
89 Trials studying Depression
18,031 Patients Enrolled for Depression
Joshua Rosenblat, MD, MScPrincipal InvestigatorUniversity Health Network, Toronto
3 Previous Clinical Trials
190 Total Patients Enrolled
2 Trials studying Depression
90 Patients Enrolled for Depression
~61 spots leftby Feb 2028
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