Study Summary
This trial studied if a drug is safe & effective for people with depression that hasn't responded to other treatments.
Eligible Conditions
- Major Depressive Disorder
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: Week 6
Week 6
COMP360 25 mg versus COMP360 1 mg for the change from baseline in MADRS total score.
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.
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
Diphenhydramine
9%Nausea
7%Pain
7%Bronchitis
7%Viral upper resp. tract infection
7%Back pain
4%Depression
4%Insomnia
4%Oropharyngeal pain
4%Diarrhea
4%Influenza
4%Suicidal Ideation
4%Headache
4%Sinus headache
4%Alcohol withdrawal syndrome
4%Depressed mood
4%Lower resp. tract congestion
2%Gingivitis
2%Musculoskeletal pain
2%Sedation
2%Sinus congestion
2%Endodontic procedure
2%Anemia
2%Thrombocytosis
2%Hyponatremia
2%Sexual abuse
2%Arthoscopic surgery
2%Fungal infection
2%Dermatitis contact
2%Restlessness
2%Pyrexia
2%Rhinorrhea
2%Constipation
2%Vomiting
2%Oedema
2%Peripheral swelling
2%Bronchitis bacterial
2%Eye infection
2%Arthralgia
2%Mallory-Weiss Syndrom
2%Influenza like Illness
2%Traumatic lung injury
2%Pain in extremity
2%Malignant melanoma
2%Dizziness
2%Hypoesthesia
2%Migraine
2%Anger
2%Anxiety
2%Cough
Trial Design
3 Treatment Groups
1 mg COMP360 Psilocybin
1 of 3
25 mg COMP360 Psilocybin
1 of 3
10 mg COMP360 Psilocybin
1 of 3
Active Control
Experimental Treatment
568 Total Participants · 3 Treatment Groups
Primary Treatment: 25 mg COMP360 Psilocybin · No Placebo Group · Phase 3
25 mg COMP360 Psilocybin
Drug
Experimental Group · 1 Intervention: Psilocybin · Intervention Types: Drug10 mg COMP360 Psilocybin
Drug
Experimental Group · 1 Intervention: Psilocybin · Intervention Types: Drug1 mg COMP360 Psilocybin
Drug
ActiveComparator Group · 1 Intervention: Psilocybin · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~560
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 6
Who is running the clinical trial?
COMPASS PathwaysLead Sponsor
13 Previous Clinical Trials
988 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have tried multiple different medications to treat your depression, but none of them worked. We can tell this by asking you some questions and looking at your medical history.
If you have never been diagnosed with depression before, your current depressive episode must be between 3 months and 2 years long.
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.
You have been diagnosed with major depression, but not with any additional psychotic features.
Who else is applying?
What state do they live in?
| Florida | 40.0% |
| California | 20.0% |
| Texas | 20.0% |
| Other | 20.0% |
What site did they apply to?
| Innovative Clinical Research, Inc. | 33.3% |
| Behavioral Clinical Research, Inc. | 66.7% |
What portion of applicants met pre-screening criteria?
| Met criteria | 75.0% |
| Did not meet criteria | 25.0% |
How many prior treatments have patients received?
| 0 | 50.0% |
| 3+ | 50.0% |
Why did patients apply to this trial?
- "I’ve researched the use of psychedelics for years. I’ve always been drawn to unconventional medicine. After watching documentaries such as “How to Change You're Mind” I felt inspired to seek a cutting edge research study. I was diagnosed with Major Depressive Disorder over 20 years ago and have yet to find medication that helps. I have many coping skills like yoga, grounding, forest bathing, Gi Gong and deep breathing. I look forward to hearing back from you soon. Erin"
What questions have other patients asked about this trial?
- "Is screening done in person or via Zoom?"
Frequently Asked Questions
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer