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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 week 3 and week 6
Awards & highlights
No Placebo-Only Group
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 3 and week 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 3 and week 6
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and tolerability of COMP360 Psilocybin
Secondary study objectives
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 • 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
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
~530
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My first major depression episode has lasted between 3 months and 2 years.My current depression treatment hasn't worked, as confirmed by a specific questionnaire.My depression didn't improve after trying a recommended medication.I have not used electroconvulsive, deep brain, or vagus nerve stimulation for my current depression.I have not been diagnosed with bipolar, schizophrenia, or similar mental health conditions.I have not had transcranial magnetic stimulation in the last 6 months.I have previously received COMP360 psilocybin therapy.I recently started or plan to change my psychological therapy during the study.You have a moderate to severe level of depression, with 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.
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 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.
Depression Patient Testimony for trial: Trial Name: NCT05733546 — Phase 2
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