Your session is about to expire
← Back to Search
Other
Psilocybin for Depression (EMBRACE Trial)
Phase 2
Waitlist Available
Led By Sean Nestor, PhD MD FRCPC
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the effects of psilocybin on brain activity in people with depression to see if it helps with mood regulation.
Who is the study for?
Adults aged 18-65 with a confirmed diagnosis of depression, experiencing a depressive episode for at least 3 months, and scoring >17 on the HAMD-17 scale. Participants must be able to attend all visits, have someone to monitor them post-treatment, and continue psychiatric care. Exclusions include pregnancy, severe heart conditions, significant arrhythmias or ECG abnormalities, recent drug abuse, certain psychiatric disorders like bipolar or schizophrenia, and those with a history of substance-induced psychosis.
What is being tested?
This trial is examining if psilocybin affects brain activity related to mood in depressed patients compared to niacin (placebo). Participants will receive either two doses of psilocybin or one dose of niacin followed by psilocybin across two sessions. Brain scans are performed after each treatment before psychotherapy to observe changes in brain connectivity and blood flow.
What are the potential side effects?
Psilocybin may cause headaches, nausea, increased heart rate or blood pressure temporarily during the session. Some individuals might experience emotional distress or confusion during the effects period but these are closely monitored by professionals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Regional Blood Flow
Secondary study objectives
16-item Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16)
17-item Hamilton Depression Rating Scale (GRID-HAMD-17)
6-Item Clinician Administered Dissociative Symptom Scale (CADSS-6)
+24 moreOther study objectives
Blood biomarkers
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: Staged Active Treatment Arm (Psilocybin-Psilocybin)Experimental Treatment2 Interventions
This group will receive psilocybin (25mg) at the first and second treatment visit, along with supportive psychotherapy.
Group II: Placebo to Active Delayed-Start Treatment Arm (MCC-Psilocybin)Experimental Treatment3 Interventions
This group will receive microcrystalline cellulose (25mg) at the first treatment visit and psilocybin (25mg) at the second treatment visit, along with supportive psychotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Supportive psychotherapy
2001
Completed Phase 4
~220
Psilocybin
2021
Completed Phase 2
~530
Find a Location
Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
681 Previous Clinical Trials
1,565,708 Total Patients Enrolled
36 Trials studying Depression
9,539 Patients Enrolled for Depression
Sean Nestor, PhD MD FRCPCPrincipal InvestigatorSunnybrook Health Sciences Centre