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Psychedelic Therapy

Single Psilocybin Treatment for Major Depressive Disorder

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

Study 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.Check my eligibility

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.See study design

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

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

Treatment Details

Study Objectives

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

Primary outcome measures

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 outcome measures

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

29%

Elevated Systolic Blood Pressure

23%

Anxiety Episode

13%

Nausea

13%

Elevated Diastolic Blood Pressure

100%

80%

60%

40%

20%

Study treatment Arm

High Dose Condition (Group)

Low 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Foundation of Hope, North CarolinaOTHER

15 Previous Clinical Trials

532 Total Patients Enrolled

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,191,022 Total Patients Enrolled

Robert K McClure, MDPrincipal InvestigatorDirector of Interventional Psychiatry

Frequently Asked Questions

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

What are the specific objectives of this research study?

"The primary objective of this investigation, conducted over a span of 2 weeks starting from the baseline assessment, is to assess alterations in QIDS SR-16 scores between the initial evaluation and 2 weeks post-treatment. Secondary endpoints comprise changes in HAM-D-17 ratings between the commencement and 6 weeks after treatment. This involves evaluating modifications in HAM-D-17 scores between baseline and two weeks following intervention. The HAM-D-17 questionnaire consists of 17 items designed to gauge depression severity, with total scores ranging from 0 to 52; higher values suggest heightened depression levels. Additionally, secondary outcomes include determining the number"

Answered by AI

What is the safety profile of a single dose psilocybin treatment for individuals?

"The safety rating for Single Psilocybin Treatment is deemed as 3 by our team at Power, aligning with the Phase 3 trial status. This indicates existing efficacy data and robust safety evidence from multiple assessments."

Answered by AI

Is the trial open to individuals older than 40 years of age?

"To be eligible for this research endeavor, individuals aged between 18 and 70 are encouraged to apply. Notably, there are a total of 227 trials catering to those under the age of majority and 1033 aimed at the elderly population above 65 years old."

Answered by AI