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
Allopurinol in Depression
Major depressive disorder (MDD) is one of the most common psychiatric disorders with serious socioeconomic consequences on daily life and health care costs. Despite the advent of newer antidepressants that target monoamine pathways, nearly 50% of patients have no response to first-line antidepressant therapy. Thus, a combination of medications with different strategies at the beginning of treatment could provide further therapeutic benefits to MDD patients.
Lifestyle Interventions to Prevent Cognitive Deficits in Subjects With Depressive Symptoms: From Mechanisms to Clinical Practice
The goal of this clinical study is to investigate if lifestyle changes can help prevent cognitive decline and reduce depressive symptoms in people between the ages of 50 and 80 with depressive symptoms or a diagnosis of major depression, but without signs of cognitive decline. The main questions it aims to answer are: * Does regular physical activity improve mood and memory in people who are depressed or have depressive symptoms? * Does cognitive training help prevent mental difficulties in people at risk of cognitive decline? * Do changes in diet and lifestyle alter the composition of the gut microbiota and immuno-related infiammatory factors? Researchers will compare three different treatment groups to see which intervention is most effective in improving mental and cognitive health. The participants: * Will take part to online sessions on healthy eating based on the Mediterranean diet * Some will do regular exercise, supervised by a personal trainer * Others will do weekly cognitive training in small groups at the hospital * They will provide blood and fecal samples and complete cognitive tests and clinical questionnaires at the beginning, at the end of the treatment (12 weeks), and after 3 months.