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Psychedelic
Psilocybin for Major Depressive Disorder - TRD
Verified Trial
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
Major depression without psychotic features (single or recurrent episode as informed by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition [DSM-5])
TRD, defined as failure to respond to an adequate dose and duration of two, three, or four different pharmacological treatments for the current episode as determined through the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ) and using the supplementary advice on additional antidepressants not included in MGH-ATRQ
Must not have
Lifetime paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder, or any ongoing serious psychiatric comorbidity based on medical history and clinical judgement
Timeline
Screening 10 weeks
Treatment Varies
Follow Up 14 weeks
Awards & highlights
Study Summary
This trial studied if a drug is safe & effective for people with depression that hasn't responded to other treatments.
Who is the study for?
This trial is for adults over 18 with treatment-resistant depression (TRD), which means their current major depressive episode hasn't improved after trying two to four different antidepressants. Participants must have a moderate severity of depression and agree to stop taking any prohibited medications.Check my eligibility
What is being tested?
The study tests the effectiveness, safety, and tolerability of COMP360 psilocybin therapy in people with TRD. It involves two administrations of the drug to see if it can help alleviate symptoms in those who haven't responded well to standard treatments.See study design
What are the potential side effects?
While not explicitly listed here, common side effects associated with psilocybin may include nausea, headache, dizziness, changes in perception or mood swings. The specific side effects will be monitored closely throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with major depression without psychosis.
Select...
I have tried 2-4 different depression medications without success.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
You have a history of certain personality disorders or ongoing serious mental health issues based on medical history and clinical judgement.
Timeline
Screening ~ 10 weeks20 visits
Treatment ~ Varies
Follow Up ~ 14 weeks4 visits
Screening ~ 10 weeks
Treatment ~ Varies
Follow Up ~14 weeks
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 COMP360 1 mg for the change from baseline in MADRS total score.
Secondary outcome measures
COMP360 25 mg versus COMP360 1 mg for the change from baseline in Sheehan Disability Scale (SDS) total score.
COMP360 25 mg versus COMP360 10 mg for the change from baseline in MADRS total score.
COMP360 25 mg versus COMP360 10 mg for the change from baseline in Sheehan Disability Scale (SDS) total score.
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%
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%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Vomiting
2%
Rhinorrhea
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, active comparator
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~730
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
COMPASS PathwaysLead Sponsor
14 Previous Clinical Trials
990 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of certain personality disorders or ongoing serious mental health issues based on medical history and clinical judgement.You have been diagnosed with Borderline Personality Disorder or show symptoms of it as per medical records or a specific interview called "MINI plus - borderline personality disorder module".I have tried 2-4 different depression medications without success.I have used specific treatments for depression recently.I have depression that didn't improve after trying 2-4 different medications.My first major depression episode has lasted between 3 months and 2 years.Your depression needs to be moderate or severe, which will be determined by a score of 20 or higher on the MADRS test during screening and baseline evaluations.I am 18 years old or older.I have been diagnosed with major depression without psychosis.At the initial observation, you must agree to discontinue any disallowed medications.I am 18 years old or older.Your depression is moderate or severe, with a score of 20 or higher on a depression rating test.I have previously received COMP360 psilocybin therapy.My first major depression episode has lasted between 3 months and 2 years.I have been diagnosed with major depression without psychosis.
Research Study Groups:
This trial has the following groups:- Group 1: 25 mg COMP360 Psilocybin
- Group 2: 10 mg COMP360 Psilocybin
- Group 3: 1 mg COMP360 Psilocybin
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 10 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 3 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 14 Weeks after you stop receiving the treatment.
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT05711940 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently taking part in this clinical research?
"Affirmative. Clinicaltrials.gov shows that, since its initial posting on February 1st 2023, this study is still actively seeking 568 individuals from 3 distinct medical centres to take part in the trial."
Answered by AI
Is this experiment taking in more participants currently?
"Data accessible on clinicaltrials.gov reveals that this medical trial is still recruiting, having been posted February 1st 2023 and most recently updated January 25th 2023."
Answered by AI
Has the FDA sanctioned 25 mg COMP360 Psilocybin for clinical application?
"There is prior clinical evidence verifying the safety of 25 mg COMP360 Psilocybin, thus affording it a score of 3."
Answered by AI
Who else is applying?
What state do they live in?
Washington
Georgia
Other
Florida
What site did they apply to?
Suburban Research Associates
Princeton Medical Institute
Innovative Clinical Research, Inc.
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
0
3+
Why did patients apply to this trial?
I have tried ev. I suffer. I won’t improve. To explore treatment options. I have depression and insomnia.
PatientReceived 1 prior treatment
Looking for something that works.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How much does it pay? How long is the process? Does Bipolar exclude me? Is there reserved parking?
PatientReceived no prior treatments
how long are screening visits?
PatientReceived 1 prior treatment
How responsive is this trial?
Most responsive sites:
- Innovative Clinical Research, Inc.: < 24 hours
- Atlanta Center for Medical Research: < 24 hours
- Segal Trials - Miami Lakes, FL: < 48 hours
Typically responds via
Email
Phone Call
Average response time
- < 2 Days
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