What the trial was testing
The COMP360 enrolled 233 patients with depression. The study was sponsored by COMPASS Pathways and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a mid-stage trial — researchers are testing whether the treatment actually works for the condition. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
37% of patients responded to a single 25-mg dose vs. 18% on the 1-mg control.
New England Journal of Medicine · 2022 · NCT03775200
These findings — that response rate at 3 weeks on single-dose 25mg psilocybin vs. 1mg control — were published in the New England Journal of Medicine and represent the headline result of the study.
Researchers tracked outcomes across 233 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with depression, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Psilocybin is NOT yet FDA-approved for depression. COMPASS Pathways' COMP360 program is now in Phase 3 trials. If you have treatment-resistant depression and are interested, ask your psychiatrist whether you might qualify for ongoing trials. The treatment requires medical supervision and structured psychological support sessions — it's not a self-administered approach.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open depression trials
Supporting Health in Veterans With Heart Failure
This study will test the effectiveness of a culturally-sensitive, telephone-based, tailored problem-solving intervention to improve physical and mental health in Veterans with heart failure (HF). Veterans will be recruited from VA clinics throughout the United States. As a component of this study, Veterans will partner with a registered nurse for a 12-week telehealth program that includes 8 telephone sessions. Follow-up data will be collected at 3-months (post intervention) and 6-, 12-, and 18-months to examine sustainability of intervention effect.
Psychosocial, Environmental, and Chronic Disease Trends in Puerto Rico
The overall goal is to identify trends and longitudinal associations in psychosocial, food-related, and cardiometabolic risk factors that can guide public health priorities and future research needs aimed at reducing cardiovascular-related disparities in Puerto Rico. To this end, investigators will establish 'PROSPECT: Puerto Rico Observational Study of Psychosocial, Environmental, and Chronic disease Trends', an island-wide, longitudinal population cohort of 2,500 adults (30-75 years) in PR recruited with a community-wide sampling strategy, and assessed in a network of several partner clinics across the island. The study will collect comprehensive data on multiple psychosocial, dietary, and food-related factors, CVD biological markers, and medical record data, with follow-up at 2-years, and will assess variations by urban-rural area and by timing before-after Maria.