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Psychedelic

Psilocybin for PTSD

Phase 2
Waitlist Available
Research Sponsored by COMPASS Pathways
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have successfully discontinued all prohibited medications at least two weeks prior to baseline visit. For fluoxetine (Prozac), immediate cessation at screening period visit 1a followed by at least four weeks of run-in will be required prior to baseline
Meet DSM-5 criteria for current PTSD resulting from a trauma experienced during adulthood measured via the PCL-5 in combination with the LEC-5 at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights

Study Summary

This trial looks at the safety and tolerability of COMP360, a new drug, in people with post-traumatic stress disorder (PTSD).

Who is the study for?
Adults with PTSD from a trauma experienced during adulthood, scoring at least 25 on the CAPS scale. Participants must have stopped certain medications like Prozac for specific periods before starting the trial and cannot be in unstable psychological therapy. They need to identify an emergency contact.Check my eligibility
What is being tested?
The trial is testing COMP360, which contains Psilocybin, for safety and tolerability in treating PTSD. It aims to understand how participants with PTSD respond to this substance compared to their usual treatments.See study design
What are the potential side effects?
Psilocybin can cause headaches, nausea, dizziness, altered sense of time and reality, emotional shifts ranging from euphoria to distress, visual alterations or hallucinations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I stopped taking certain medications 2 weeks ago, and Prozac 5 weeks ago.
Select...
I have PTSD from an adult trauma, confirmed by specific tests.
Select...
I have PTSD from an adult trauma with a CAPS score of at least 25.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety
Secondary outcome measures
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) from baseline
Change in PTSD checklist for DSM-5 (PCL-5) from baseline
Change in Sheehan Disability Scale (SDS) total score from baseline

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
44%
Headache
21%
Nausea
15%
Anxiety
8%
Suicidal Ideation
6%
Insomnia
6%
Depressed mood
4%
Abdominal pain upper
4%
Vomiting
4%
Corona virus infection
4%
Upper respiratory tract infection
4%
Viral upper resp. tract infection
4%
Alcohol poisoning
4%
Depression
4%
Pneumonia
2%
Urinary incontinence
2%
Illusion
2%
Biopsy cervix
2%
Palpitations
2%
Cataract
2%
Abdominal pain
2%
Toothache
2%
Pain
2%
Limb injury
2%
Muscle strain
2%
Blood pressure diastolic increased
2%
Blood pressure increased
2%
Back pain
2%
Musculoskeletal pain
2%
Myalgia
2%
Dizziness
2%
Psychomotor hyperactivity
2%
Alcohol withdrawal syndrome
2%
Dysphoria
2%
Testicular pain
2%
Hyperventilation
2%
Food poisoning
2%
Food allergy
2%
Dyspepsia
2%
Influenza
2%
Nasal congestion
2%
Skin cosmetic procedure
2%
Photopsia
2%
Diverticulitis
2%
Asthenia
2%
Fatigue
2%
Gingivitis
2%
Dyspnea
2%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Psilocybin
Diphenhydramine

Trial Design

1Treatment groups
Experimental Treatment
Group I: COMP360 PsilocybinExperimental Treatment1 Intervention
25 mg COMP360 Psilocybin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~770

Find a Location

Who is running the clinical trial?

COMPASS PathwaysLead Sponsor
14 Previous Clinical Trials
1,536 Total Patients Enrolled

Media Library

COMP360 (Psychedelic) Clinical Trial Eligibility Overview. Trial Name: NCT05312151 — Phase 2
Post-Traumatic Stress Disorder Research Study Groups: COMP360 Psilocybin
Post-Traumatic Stress Disorder Clinical Trial 2023: COMP360 Highlights & Side Effects. Trial Name: NCT05312151 — Phase 2
COMP360 (Psychedelic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05312151 — Phase 2
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT05312151 — Phase 2

Frequently Asked Questions

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

Has the FDA cleared psilocybin for therapeutic use?

"Psilocybin's safety is estimated to be a 2. This is due to it being in Phase 2 of clinical trials, where there is evidence backing its safety, but not its efficacy."

Answered by AI

Are investigators looking for more participants in this trial?

"Yes, the information on clinicaltrials.gov points out that this trial is actively searching for candidates. The trial was first posted on 7/1/2022 and was most recently edited on 7/20/2022. The clinical trial is looking for 20 participants at 1 location."

Answered by AI

How many total patients are enrolled in this research program?

"The listing on clinicaltrials.gov verifies that this study is recruiting patients as of 7/20/2022. This research was first made public on 7/1/2022, and will continue to enroll 20 individuals at a single site."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
New Jersey
Other
New York
How old are they?
65+
18 - 65
What site did they apply to?
Icahn School of Medicine at Mount Sinai
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

The quality of my life is very poor. antidepressants don't help my depression.
PatientReceived 1 prior treatment
I still have flashbacks from my PTSD. I suffer a lot. I have tried 12 different drugs. Have stopped dringinf.
PatientReceived 1 prior treatment
Curious about psilocybin to treat PTSD, depression and anxiety.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

What are the next steps? How long do the screening visits take? What can I expect with how the trial will go?
PatientReceived 2+ prior treatments
How long is each session? How many sessions are there?
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Email
Most responsive sites:
  1. Icahn School of Medicine at Mount Sinai: < 24 hours
~8 spots leftby Mar 2025