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Psychedelic

Psilocybin for Depression

Phase 2
Recruiting
Led By Scott Aaronson, MD
Research Sponsored by Sheppard Pratt Health System
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 baseline (v2) to day 1 (v4), week 1 (v5), week 2 (v6), week 3 (v7), week 6 (v8), week 9 (v9) and week 12 (v10)
Awards & highlights

Study Summary

This trial will study the effects of a single dose of psilocybin on adults with treatment-resistant depression and chronic suicidal ideation.

Who is the study for?
This trial is for adults aged 18-65 with Major Depressive Disorder who haven't improved after trying at least two medications and have ongoing suicidal thoughts but no immediate intent to harm themselves. It's not open to those with schizophrenia, bipolar disorder, borderline personality disorder, or current substance abuse issues.Check my eligibility
What is being tested?
The study tests the safety and effects of a single dose of Psilocybin (25mg) given in a supportive setting to see if it can help people with treatment-resistant depression and chronic thoughts of suicide.See study design
What are the potential side effects?
Possible side effects may include temporary changes in perception, mood swings, dizziness, nausea, headache or fatigue. Long-term psychological effects are also possible but will be closely monitored.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (v2) to day 1 (v4), week 1 (v5), week 2 (v6), week 3 (v7), week 6 (v8), week 9 (v9) and week 12 (v10)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (v2) to day 1 (v4), week 1 (v5), week 2 (v6), week 3 (v7), week 6 (v8), week 9 (v9) and week 12 (v10) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Columbia-Suicide Severity Rating Scale (C-SSRS)
Secondary outcome measures
Clinical Global Impression - Modified for Depression (CGI-D)
Feeling suicidal (finding)
Concise Health Risk Tracking Self Report 12 Items (CHRT-SR)
+1 more
Other outcome measures
Modified Scale for Suicidal Ideation (MSSI)

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
9%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Suicidal Ideation
4%
Oropharyngeal pain
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Restlessness
2%
Fungal infection
2%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Vomiting
2%
Rhinorrhea
2%
Musculoskeletal pain
2%
Peripheral swelling
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin

Trial Design

1Treatment groups
Experimental Treatment
Group I: PsilocybinExperimental Treatment1 Intervention
25mg of Psilocybin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Sheppard Pratt Health SystemLead Sponsor
21 Previous Clinical Trials
7,789 Total Patients Enrolled
COMPASS PathwaysIndustry Sponsor
14 Previous Clinical Trials
1,538 Total Patients Enrolled
Scott Aaronson, MDPrincipal InvestigatorSheppard Pratt Health System
3 Previous Clinical Trials
837 Total Patients Enrolled

Media Library

Psilocybin (Psychedelic) Clinical Trial Eligibility Overview. Trial Name: NCT05220410 — Phase 2
Suicidal Thoughts Research Study Groups: Psilocybin
Suicidal Thoughts Clinical Trial 2023: Psilocybin Highlights & Side Effects. Trial Name: NCT05220410 — Phase 2
Psilocybin (Psychedelic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05220410 — Phase 2
Suicidal Thoughts Patient Testimony for trial: Trial Name: NCT05220410 — Phase 2

Frequently Asked Questions

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

Is this study accessible to individuals under 85 years of age?

"Patients that meet the age criteria of this study must be over 18 years old and not exceed 65 years."

Answered by AI

Who is eligible to be enrolled in this medical research?

"To be eligible for this trial, participants must express suicidal thoughts and lie within the age range of 18 to 65. This research is taking on a maximum of 20 volunteers."

Answered by AI

Is enrollment now open for this investigation?

"Verified. Clinicaltrials.gov states that this investigation, which was initially published on March 28th 2022, is currently enrolling test subjects. A single medical centre requires 20 volunteers for the study."

Answered by AI

Has the Food and Drug Administration sanctioned Psilocybin for therapeutic use?

"Our team at Power believes that Psilocybin is moderately safe and has assigned it a score of 2. This rating takes into account the existing data on safety, but there is yet to be any conclusive information about efficacy."

Answered by AI

What is the current size of the cohort under assessment in this trial?

"Affirmative. According to clinicaltrials.gov, this medical exploration is actively recruiting patients and was initially released on March 28th 2022. Its details were most recently updated on October 24th of the same year and it requires 20 individuals from a single centre for participation."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Florida
Maryland
Other
How old are they?
65+
18 - 65
What site did they apply to?
Sheppard Pratt Health System
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
2
3+

Why did patients apply to this trial?

I need help. I want to move past this after more than 10 years of having the thoughts.
PatientReceived no prior treatments
I have tried meds, therapy, ECT, TMS, spravato and ketamine. Some meds and Ketamine help but don't fix it.
PatientReceived 2+ prior treatments
I've had MDD for over two decades, and the dozens of treatments I've tried have only brought partial relief.
PatientReceived 1 prior treatment
I've tried different types of medication to no avail and I'm willing to try whatever you have in hopes of finding a reason to live.
PatientReceived no prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Sheppard Pratt Health System: < 24 hours
Typically responds via
Email
Phone Call
Recent research and studies
clinicaltrials.govStudy
The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation
Scott T. Aaronson, M.D 2022. "The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05220410.
~7 spots leftby Apr 2025
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