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Psychedelic Therapy

Psilocybin-Assisted Therapy for Depression

Phase 3
Recruiting
Led By Robert K McClure, MD
Research Sponsored by University of North Carolina, Chapel Hill
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 up to 1 year after treatment
Awards & highlights

Summary

"This trial aims to test how effective psilocybin-assisted therapy is in treating depression. Participants will undergo screening, receive psilocybin treatment, and attend follow-up sessions over a year.

Who is the study for?
This trial is for individuals with depression that hasn't improved with standard treatments. Participants will undergo screening visits, receive psilocybin in one or two sessions, and attend follow-ups over a year to monitor changes in their symptoms.
What is being tested?
The study tests the effectiveness of psilocybin-assisted therapy on improving depressive symptoms and how long these benefits last. It compares the outcomes between receiving one versus two treatment sessions.
What are the potential side effects?
Possible side effects of psilocybin may include nausea, headache, dizziness, increased heart rate or blood pressure, emotional distress, and altered perception during treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year after treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year after treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in HAM-D-17 Scores between Baseline and 2 Weeks after Treatment
Change in QIDS SR-16 Scores between Baseline and 2 Weeks after Treatment
Number of Participants Achieving Remission 2 Weeks after Treatment
+1 more
Secondary study objectives
Change in HAM-D-17 Scores between Baseline and 12 Months after Treatment
Change in HAM-D-17 Scores between Baseline and 3 Months after Treatment
Change in HAM-D-17 Scores between Baseline and 6 Months after Treatment
+19 more

Side effects data

From 2016 Phase 2 trial • 56 Patients • NCT00465595
16%
Elevated Systolic Blood Pressure
13%
Anxiety Episode
2%
Elevated Diastolic Blood Pressure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Low Dose Condition (Group)
High Dose Condition (Group)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Single Psilocybin TreatmentExperimental Treatment1 Intervention
Participants will be administered one dose of a 25mg capsule of psilocybin. This will be administered one time.
Group II: Two Psilocybin TreatmentsActive Control1 Intervention
Participants will be administered one dose of a 25mg capsule of psilocybin. Two weeks later, the participant will be administered one more dose of a 25mg capsule of psilocybin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
psilocybin
2009
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

Foundation of Hope, North CarolinaOTHER
16 Previous Clinical Trials
600 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,543 Previous Clinical Trials
4,249,022 Total Patients Enrolled
Robert K McClure, MDPrincipal InvestigatorDirector of Interventional Psychiatry
~13 spots leftby Sep 2025
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