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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 12 weeks
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety
Secondary study objectives
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 • NCT020612939%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Insomnia
4%
Suicidal Ideation
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Migraine
2%
Thrombocytosis
2%
Constipation
2%
Vomiting
2%
Oedema
2%
Peripheral swelling
2%
Pyrexia
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Eye infection
2%
Fungal infection
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Musculoskeletal pain
2%
Pain in extremity
2%
Malignant melanoma
2%
Dizziness
2%
Hypoesthesia
2%
Sedation
2%
Anger
2%
Anxiety
2%
Restlessness
2%
Cough
2%
Rhinorrhea
2%
Sinus congestion
2%
Sexual abuse
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~750
Find a Location
Who is running the clinical trial?
COMPASS PathwaysLead Sponsor
14 Previous Clinical Trials
1,536 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have PTSD from an adult trauma, confirmed by specific tests.I have PTSD from an adult trauma with a CAPS score of at least 25.I was diagnosed with major depression in the last 6 months.I'm sorry, I cannot provide a summary for this criterion as it is incomplete. Please provide me with the complete criterion.I stopped taking certain medications 2 weeks ago, and Prozac 5 weeks ago.
Research Study Groups:
This trial has the following groups:- Group 1: COMP360 Psilocybin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT05312151 — Phase 2
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