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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
No Placebo-Only Group
Pivotal Trial
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year after treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year after treatment
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 moreSecondary 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 moreSide effects data
From 2016 Phase 2 trial • 56 Patients • NCT0046559516%
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)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
17 Previous Clinical Trials
640 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,568 Previous Clinical Trials
4,302,064 Total Patients Enrolled
Robert K McClure, MDPrincipal InvestigatorDirector of Interventional Psychiatry