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Psychedelic

Psilocybin for Depression

Phase 2
Recruiting
Research Sponsored by COMPASS Pathways
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 week 3 and week 6
Awards & highlights

Study Summary

This trial tested if a single dose of a new drug is safe, tolerated, and effective for people with major depressive disorder who didn't respond to prior treatment.

Who is the study for?
Adults with Major Depressive Disorder who haven't improved after one antidepressant treatment, as verified by a specific questionnaire. They must have moderate depression severity and agree to stop taking certain medications. Excluded are those with certain personality disorders, recent psychiatric hospitalization, bipolar or psychotic disorders, ongoing serious mental health issues, or recent use of intensive psychiatric treatments.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of a single dose of COMP360 psilocybin for people with depression who didn't respond well to their first treatment. It's a controlled study where some participants will receive the actual medication while others may receive a placebo without knowing which one they're getting.See study design
What are the potential side effects?
Potential side effects from psilocybin can include changes in perception, mood swings, dizziness, nausea, headaches and could potentially exacerbate certain mental health conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 3 and week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 3 and week 6 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 and tolerability of COMP360 Psilocybin
Secondary outcome measures
Change from baseline in MADRS total score at Week 3 and Week 6 for COMP360 25 mg versus COMP360 1 mg
Pharmacokinetics of COMP360 Psilocybin

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

3Treatment groups
Experimental Treatment
Active Control
Group I: 25 mg COMP360 PsilocybinExperimental Treatment1 Intervention
25 mg COMP360 Psilocybin
Group II: 10 mg COMP360 PsilocybinExperimental Treatment1 Intervention
10 mg COMP360 Psilocybin
Group III: 1 mg COMP360 PsilocybinActive Control1 Intervention
1 mg COMP360 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?

COMPASS PathwaysLead Sponsor
14 Previous Clinical Trials
1,456 Total Patients Enrolled
8 Trials studying Depression
778 Patients Enrolled for Depression

Media Library

Psilocybin (Psychedelic) Clinical Trial Eligibility Overview. Trial Name: NCT05733546 — Phase 2
Depression Research Study Groups: 25 mg COMP360 Psilocybin, 10 mg COMP360 Psilocybin, 1 mg COMP360 Psilocybin
Depression Clinical Trial 2023: Psilocybin Highlights & Side Effects. Trial Name: NCT05733546 — Phase 2
Psilocybin (Psychedelic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05733546 — Phase 2
Depression Patient Testimony for trial: Trial Name: NCT05733546 — 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 25 mg dose of COMP360 Psilocybin been verified by the FDA?

"Our team at Power have evaluated 25 mg COMP360 Psilocybin as a 2 on the safety scale due to its Phase 2 status; meaning there is an indication of security, but no clinical data yet proving efficacy."

Answered by AI

How many participants have been accepted into this investigation?

"Yes, official records provided on clinicaltrials.gov suggest that this research is in the process of enrolling participants. The project was first posted to the website on February 1st 2023 and has since been updated as recently as August 2nd 2023; 102 individuals are being recruited across one centre."

Answered by AI

Is enrollment for this research ongoing?

"Accurately, the scientific research posted on clinicaltrials.gov attests that this medical investigation is currently seeking volunteers. The trial was initially posted on February 1st 2023 and has been recently updated as of August 2nd 2023. A total of 102 individuals are required for the experiment to be conducted from one site."

Answered by AI

Who else is applying?

What state do they live in?
California
Virginia
Maryland
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
3+
What site did they apply to?
Elixia MA, LLC
Aims Trial
Sunstone Therapies

Why did patients apply to this trial?

Will try anything to be happy and have a life. I've tried many antidepressants, and they did not work.
PatientReceived 1 prior treatment
I want to try another treatment to I don't have to take multiple different medications on several different times of day.
PatientReceived 2+ prior treatments
I am taking 2 rx for depression and anxiety but I am still depressed because I have ADD and am in recovery from opiates for 5 years.
PatientReceived 1 prior treatment
I have dealt with depression as early as the age of 14. It has only gotten worse as I get older, and nothing seems to help me anymore.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

When does it start? What screening visits are required? What is the time frame for this study?
PatientReceived 2+ prior treatments
Is there after care at all? For example, if after this trial is over and I’m feeling off some weeks down the line is there any care available?
PatientReceived 2+ prior treatments
How long do the visits take? Is there anything I should be concerned about? What should I expect? What will happen if the treatment was helpful for me after the study?
PatientReceived no prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. Sunstone Therapies: < 48 hours
Recent research and studies
clinicaltrials.govStudy
A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Recurrent Major Depressive Disorder
2023. "A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Recurrent Major Depressive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05733546.
All > Mdd
~25 spots leftby Oct 2024
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