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Psychedelic Therapy

Two Doses of Psilocybin 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

Awards & highlights

PSI-1V2 Trial 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.Check my eligibility

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.See study design

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.

PSI-1V2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6 month follow-up

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Antidepressant Efficacy

Secondary outcome measures

Anxiety Symptoms

Cognitive Dysfunction

Effort-Based Decision Making

+9 more

Other outcome measures

EEG Predictors of Response

Expectancy Effects

Participant Blinding Success

+3 more

PSI-1V2 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,476 Previous Clinical Trials

485,088 Total Patients Enrolled

53 Trials studying Depression

12,058 Patients Enrolled for Depression

Centre for Addiction and Mental HealthOTHER

356 Previous Clinical Trials

81,366 Total Patients Enrolled

85 Trials studying Depression

19,159 Patients Enrolled for Depression

Joshua Rosenblat, MD, MScPrincipal InvestigatorUniversity Health Network, Toronto

2 Previous Clinical Trials

160 Total Patients Enrolled

1 Trials studying Depression

60 Patients Enrolled for Depression

Frequently Asked Questions

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

Does this research project include individuals older than thirty years of age?

"To be eligible for this trial, individuals must meet the age requirements of being at least 18 years old and no older than 65."

Answered by AI

How many individuals in total are enrolled as participants in this medical study?

"Affirmative. Records from clinicaltrials.gov affirm that this research endeavor is presently seeking participants. Originally shared on February 5th, 2024, the latest update was made on April 1st of the same year. The objective is to enlist 92 individuals at a single designated site."

Answered by AI

Which individuals are eligible to participate in this clinical trial?

"To qualify for participation in this research, individuals must be diagnosed with depression and fall between the ages of 18 and 65. The study aims to enroll a maximum of 92 participants."

Answered by AI

Are researchers currently enrolling participants for this study?

"Indeed, information available on clinicaltrials.gov indicates that this investigation is actively seeking eligible individuals. The trial was initial listed on February 5th, 2024 and the most recent update occurred on April 1st, 2024. A total of 92 candidates are sought from a single designated site."

Answered by AI

Has the FDA sanctioned a regimen of administering two doses of psilocybin?

"The safety rating for the administration of two doses of psilocybin is assessed by our team at Power as a 2 on the scale, considering this trial falls under Phase 2. This implies that while there exists some evidence regarding safety, no data supports efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Psilocybin-Assisted Psychotherapy for Treatment-Resistant Depression: Comparing One Versus Two Doses of Psilocybin

Joshua Rosenblat 2024. "Psilocybin-Assisted Psychotherapy for Treatment-Resistant Depression: Comparing One Versus Two Doses of Psilocybin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06341426.