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Psychedelic

Psilocybin for Treatment-Resistant Depression

Phase 3
Recruiting
Research Sponsored by COMPASS Pathways
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged ≥18 years at Screening
Major depression without psychotic features (single or recurrent episode as informed by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition [DSM-5])
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6
Awards & highlights

Study Summary

This trial found a single dose of COMP360 was safe and effective for treating depression that doesn't respond to standard treatments.

Who is the study for?
Adults over 18 with treatment-resistant depression (TRD), who haven't responded to at least two different antidepressants, can join this trial. They must have moderate to severe depression without psychotic features and agree to stop taking any prohibited medications. The current depressive episode should be their first or ongoing for 3 months to 2 years.Check my eligibility
What is being tested?
The trial is testing the effectiveness, safety, and tolerability of a single dose of COMP360 psilocybin in individuals with TRD. It aims to see if this one-time treatment can help where standard antidepressants have failed.See study design
What are the potential side effects?
While not specified here, psilocybin may cause temporary side effects such as headaches, altered sensory experiences and perception changes, nausea, dizziness, and emotional shifts during administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with major depression without psychosis.
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I have tried 2-4 different depression medications without success.
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I am 18 years old or older.
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I have been diagnosed with major depression without psychosis.
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I have tried 2-4 different depression medications without success.
Select...
I am 18 years old or older.
Select...
I have been diagnosed with major depression without psychosis.
Select...
My depression hasn't improved after trying 2-4 different medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, 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
COMP360 25 mg versus placebo for the change from baseline in MADRS total score
Secondary outcome measures
COMP360 25 mg versus placebo for the change from baseline in SDS total score

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

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 25 mg COMP360 PsilocybinExperimental Treatment1 Intervention
25 mg COMP360 Psilocybin
Group II: PlaceboPlacebo Group1 Intervention
Matched placebo
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
1,180 Total Patients Enrolled

Media Library

Major Depressive Disorder Research Study Groups: 25 mg COMP360 Psilocybin, Placebo
Major Depressive Disorder Clinical Trial 2023: Psilocybin Highlights & Side Effects. Trial Name: NCT05624268 — Phase 3
Psilocybin (Psychedelic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05624268 — Phase 3

Frequently Asked Questions

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

What is the capacity of this clinical trial in terms of participants?

"Affirmative. The details on clinicaltrials.gov attest to this trial's present recruitment status, which commenced in November 1st 2022 with a recent update made on the 14th of that same month. This medical assessment requires 378 volunteers from 6 distinct sites."

Answered by AI

Has the Federal Drug Administration sanctioned 25 mg COMP360 Psilocybin?

"As the trial has advanced to Phase 3, our team at Power assigned 25 mg COMP360 Psilocybin a score of 3 on their safety scale. This is due to existing proof-of-concept data and multiple rounds of results affirming its security."

Answered by AI

How many healthcare institutions are administering this trial?

"Currently, the clinical trial is taking place at 6 sites across America, including Draper, Baltimore and Gaithersburg. To reduce travel needs, it's best to choose a location close by if you decide to participate in this study."

Answered by AI

Is enrollment into this experiment accessible to individuals right now?

"According to clinicaltrials.gov, this ongoing trial is actively recruiting patients; the initial post was made on November 1st of 2022 and its details were last updated two weeks later."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
Texas
Maryland
Other
What site did they apply to?
Sheppard Pratt Health System
CBH Health, LLC
UT Health Science Center at Houston (UTHSC-H)
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
0
3+

Why did patients apply to this trial?

I need help. a lifetime of depression. Still looking for a better solution.
PatientReceived 1 prior treatment
Im on a medication and it is not working. Tried many other drugs with little relief.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

what are visit requirements? How long does screening take? How is this study randomized?
PatientReceived 2+ prior treatments
How long do screening visits take ?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. CBH Health, LLC: < 24 hours
  2. University of Minnesota: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Efficacy, Safety, and Tolerability of a Single Administration of COMP360 in Participants With TRD
2023. "Efficacy, Safety, and Tolerability of a Single Administration of COMP360 in Participants With TRD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05624268.
All > Depression Los Angeles
~94 spots leftby Oct 2024
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