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Psychedelic

Psilocybin for Major Depressive Disorder

Phase 2
Waitlist Available
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 from baseline (day -1) to three weeks post-dose.
Awards & highlights

Study Summary

This trial will test whether psilocybin can help people with severe treatment-resistant depression.

Eligible Conditions
  • Major Depressive Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (day -1) to three weeks post-dose.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (day -1) to three weeks post-dose. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Montgomery Asberg Depression Rating Scale (MADRS)

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%
Rhinorrhea
2%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Vomiting
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
2021
Completed Phase 2
~730

Find a Location

Who is running the clinical trial?

Sheppard Pratt Health SystemLead Sponsor
21 Previous Clinical Trials
7,782 Total Patients Enrolled
COMPASS PathwaysIndustry Sponsor
14 Previous Clinical Trials
1,531 Total Patients Enrolled
Scott Aaronson, MDPrincipal InvestigatorSheppard Pratt Health System
3 Previous Clinical Trials
830 Total Patients Enrolled

Media Library

Psilocybin (Psychedelic) Clinical Trial Eligibility Overview. Trial Name: NCT04433858 — Phase 2
Major Depressive Disorder Research Study Groups: Psilocybin
Major Depressive Disorder Clinical Trial 2023: Psilocybin Highlights & Side Effects. Trial Name: NCT04433858 — Phase 2
Psilocybin (Psychedelic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04433858 — Phase 2

Frequently Asked Questions

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

What is the FDA's stance on Psilocybin?

"While there is some evidence indicating that psilocybin is safe, as this is a phase 2 trial, there is no data currently supporting its efficacy. Thus, it received a score of 2."

Answered by AI

How can I become a part of this research project?

"Eligible patients for this clinical trial must suffer from melancholia and be aged 18 to 65. So far, 27 people have been recruited."

Answered by AI

Are new participants still being accepted for this experiment?

"That is correct, the information available on clinicaltrials.gov demonstrates that this trial has open positions. The posting date was March 1st 2021 with the most recent update being October 24th 2022. They are seeking 27 patients who would be located at 2 different medical facilities."

Answered by AI

What other psilocybin studies have been undertaken in the past?

"There are currently 37 clinical trials underway that are researching psilocybin. 0 of those active studies are in the third and final phase. The majority of these trials for psilocybin are based in Vancouver, Washington; however, there are 40 total locations running these sorts of experiments."

Answered by AI

How many guinea pigs are trialing this novel therapy?

"Yes, that is accurate. The listing on clinicaltrials.gov says that this study is open for 27 more participants at 2 locations. The trial was first posted on March 1st, 2021 and was most recently updated on October 24th, 2022."

Answered by AI

Can adults aged 50 years and older participate in this clinical trial?

"This trial is only open for applicants who are within the ages of 18 to 65. Out of the 1241 ongoing clinical trials, this age group makes up 205 studies and 1036 are for those outside of this demographic."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
New York
Other
California
How old are they?
65+
18 - 65
What site did they apply to?
VA Palo Alto Healthcare System/Stanford Medicine
Stanford Exploratory Therapeutics Laboatory
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Most responsive sites:
  1. Stanford Exploratory Therapeutics Laboatory: < 24 hours
  2. VA Palo Alto Healthcare System/Stanford Medicine: < 24 hours
Average response time
  • < 2 Days
Typically responds via
Phone Call
Email
Recent research and studies
clinicaltrials.govStudy
An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)
Scott T. Aaronson, M.D 2021. "An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04433858.
~7 spots leftby Apr 2025
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