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Psilocybin for Depression

Phase 1
Waitlist Available
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with Major Depressive Disorder (MDD), single or recurrent episode, and currently experiencing a Major Depressive Episode (MDE)
Failed to achieve a satisfactory clinical response to at least one adequate antidepressant trial during the current depressive episode
Timeline
Screening 3 weeks
Treatment Varies
Follow Up four weeks before the initiation of testing, the day before and after each experimental session, and one and two weeks after each experimental session.
Awards & highlights

Study Summary

This trial will investigate whether psilocybin can change the brain in a way that relieves symptoms of depression.

Who is the study for?
This trial is for adults with Major Depressive Disorder who haven't improved after trying at least one antidepressant. Participants must be currently seeing a mental health professional and not have any psychotic disorders, drug abuse issues, or unstable medical conditions. Pregnant or breastfeeding individuals are excluded, as well as those without proper birth control.Check my eligibility
What is being tested?
The study tests if psilocybin can cause changes in the brain that improve depression symptoms. It compares the effects of two different doses of psilocybin to a placebo (a substance with no active drug).See study design
What are the potential side effects?
Psilocybin may cause temporary changes in perception, mood swings, dizziness, nausea, and headaches. Some people might experience intense emotional experiences or anxiety during its use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Major Depressive Disorder and am currently experiencing a depressive episode.
Select...
My current depression treatment hasn't worked.
Select...
I am currently seeing a mental health professional.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four weeks before the initiation of testing, the day before and after each experimental session, one and two weeks after each experimental session, then monthly for three months after the last experimental session.
This trial's timeline: 3 weeks for screening, Varies for treatment, and four weeks before the initiation of testing, the day before and after each experimental session, one and two weeks after each experimental session, then monthly for three months after the last experimental session. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in electrical brain activity associated with neuroplasticity measured by Electroencephalography (EEG)
Secondary outcome measures
Change in mood symptoms using the GRID-Hamilton Depression Rating Scale (GRID-HAM-D)
Change in mood symptoms using the Quick Inventory of Depressive Symptoms (QIDS-SR16)
Changes in verbal memory [ Time Frame: One day and two weeks after each experimental session ]

Trial Design

4Treatment groups
Experimental Treatment
Group I: Placebo/Medium Dose PsilocybinExperimental Treatment2 Interventions
Subjects in this arm receive placebo in the first session and medium dose psilocybin in the second session.
Group II: Placebo/Low Dose PsilocybinExperimental Treatment2 Interventions
Subjects in this arm receive placebo in the first session and low dose psilocybin in the second session.
Group III: Medium Dose Psilocybin/PlaceboExperimental Treatment2 Interventions
Subjects in this arm receive medium dose psilocybin in the first session and placebo in the second session.
Group IV: Low Dose Psilocybin/PlaceboExperimental Treatment2 Interventions
Subjects in this arm receive low dose psilocybin in the first session and placebo in the second session.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low Dose Psilocybin
2017
Completed Phase 1
~20
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,851 Previous Clinical Trials
2,738,195 Total Patients Enrolled
63 Trials studying Depression
20,628 Patients Enrolled for Depression
Heffter Research InstituteOTHER
13 Previous Clinical Trials
480 Total Patients Enrolled
3 Trials studying Depression
110 Patients Enrolled for Depression

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT03554174 — Phase 1
Depression Research Study Groups: Placebo/Low Dose Psilocybin, Placebo/Medium Dose Psilocybin, Low Dose Psilocybin/Placebo, Medium Dose Psilocybin/Placebo
Depression Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT03554174 — Phase 1
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT03554174 — Phase 1
Depression Patient Testimony for trial: Trial Name: NCT03554174 — Phase 1

Frequently Asked Questions

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

Could you provide a synopsis of previous experiments that have used Medium Dose Psilocybin?

"Currently, 33 clinical trials involving medium-dose psilocybin are being conducted. None of them have yet reached Phase 3. These experiments are mainly based in Vancouver, Washington but encompass 36 different locations on the whole."

Answered by AI

What is the total sample size of this research project?

"This clinical study has since closed recruitment. It was initially posted on February 27th 2018, and last updated on July 15th 2022. For those seeking alternative studies, 1295 investigations are recruiting patients with depression while 33 trials are currently enrolling participants for the Medium Dose Psilocybin protocol."

Answered by AI

Is the experiment still recruiting participants?

"This trial is no longer recruiting participants, as it was last updated on July 15th 2022. For those seeking out other opportunities to participate in medical research, there are presently 1295 studies actively enrolling individuals with depression and 33 separate trials for Medium Dose Psilocybin requesting volunteers."

Answered by AI

What are the eligibility requirements for participating in this clinical trial?

"This medical study seeks 18 individuals with Major Depressive Disorder (MDD) aged between the ages of consent and 65. Specifically, participants must be currently undergoing treatment for depression under a mental health clinician, have experienced either single or recurrent episodes of MDD and are presently in the midst of an MDE."

Answered by AI

Does the FDA endorse medium dose psilocybin use?

"Due to the limited amount of data related to both safety and efficacy, Medium Dose Psilocybin has been rated a 1 on our team's scale. This is in accordance with its status as being part of Phase 1 clinical trials."

Answered by AI

Is there an age cutoff for participants of this research endeavor?

"This experiment is open to any individual 18 years and older, up until the age of 65."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
New York
Connecticut
Other
How old are they?
65+
18 - 65
What site did they apply to?
VA Connecticut Healthcare System, West Haven Campus
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
3+

Why did patients apply to this trial?

I feel disconnected fro. I've been on Prozac since the 90's. The quality of my life is very poor.
PatientReceived 2+ prior treatments
I have tried more then 12 medications and not found relief. I am interested in learning more about Psilocybin to treat depression.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

When will treatment start? What is the schedule of visits throughout the trial?
PatientReceived 2+ prior treatments
How long do screenings take? How does this trial work? How long do the trials take? How is the substance ingested?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. VA Connecticut Healthcare System, West Haven Campus: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder
Deepak C. D'Souza 2018. "Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03554174.
All > Mdd
~3 spots leftby Apr 2025
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