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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 below
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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:
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You have a history of certain personality disorders or ongoing serious mental health issues based on medical history and clinical judgement.

Timeline

Screening ~ 10 weeks
Treatment ~ Varies
Follow Up ~14 weeks
This trial's timeline: 10 weeks for screening, Varies for treatment, and 14 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
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 • NCT02061293
9%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Suicidal Ideation
4%
Influenza
4%
Oropharyngeal pain
4%
Insomnia
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Peripheral swelling
2%
Pyrexia
2%
Oedema
2%
Rhinorrhea
2%
Fungal infection
2%
Musculoskeletal pain
2%
Hypoesthesia
2%
Restlessness
2%
Vomiting
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
~740

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Major Depressive Disorder (MDD) include pharmacological and psychotherapeutic approaches. Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) work by increasing the levels of serotonin and norepinephrine in the brain, which helps improve mood and emotional stability. Psilocybin, a serotonin 5-HT2A receptor agonist, is being studied for its potential to produce rapid and sustained reductions in depressive symptoms by altering brain connectivity and promoting neuroplasticity. Psychotherapy, such as cognitive-behavioral therapy (CBT), helps patients by changing negative thought patterns and behaviors. Understanding these mechanisms is crucial for MDD patients as it informs treatment choices and helps tailor interventions to individual needs, potentially improving outcomes and quality of life.

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

Psilocybin (Psychedelic) Clinical Trial Eligibility Overview. Trial Name: NCT05711940 — Phase 3
Major Depressive Disorder Research Study Groups: 25 mg COMP360 Psilocybin, 10 mg COMP360 Psilocybin, 1 mg COMP360 Psilocybin
Major Depressive Disorder Clinical Trial 2023: Psilocybin Highlights & Side Effects. Trial Name: NCT05711940 — Phase 3
Psilocybin (Psychedelic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05711940 — Phase 3
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT05711940 — Phase 3
~189 spots leftby Mar 2025