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DepressionNovember 2022Summary reviewed May 2026

A Single Dose of Psilocybin Improved Depression in 37% of Patients Within 3 Weeks

COMP360 tested whether a single 25-mg dose of psilocybin — the active compound in psychedelic mushrooms — given alongside structured psychological support, helps adults with treatment-resistant depression. Across 233 patients at 22 sites, the 25-mg dose lifted depression scores significantly more than a tiny 1-mg control at 3 weeks.

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

RecruitingInterventional study

Creating Health Course Study for People With Rheumatological Conditions and Mood Disorders

The goal of this project is to critically evaluate the effectiveness of an online health program designed to improve diet and self-care in patients with rheumatological conditions, including rheumatoid arthritis (RA), Sjogren's syndrome (SS), systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), psoriatic arthritis (PsA), anxiety disorders, depressive disorders and moderate depression. Additionally, investigators will assess the program's effectiveness, as well as the challenges and facilitators involved in using an online wellness program to reduce fatigue and enhance the quality of life in patients suffering from these conditions.

Iowa City, Iowa, United States
RecruitingInterventional study

Activating Social Resources in Psychotherapy-Seeking Individuals: Effectiveness and Timing of a Social Support Just-in-Time Adaptive Intervention

This study evaluates a Just-In-Time Adaptive Intervention (JITAI) aiming to foster social support processes for adults with elevated depressive symptoms awaiting outpatient psychotherapy. Utilizing a daily-level micro-randomized trial (MRT) design conducted over 21 days, participants are assessed six times daily. Participants are randomized across four conditions: (1) vulnerability-triggered, (2) vulnerability and receptivity-triggered, (3) support-need-triggered, and (4) a no-intervention control. The primary objective of this study is to evaluate the effectiveness of the JITAI in reducing daily depressive symptoms and increasing received social support (primary outcomes), as well as reducing daily loneliness and enhancing perceived social support (secondary outcomes). Furthermore, the study aims to compare the relative efficacy of three distinct triggering strategies to identify the most effective timing for intervention delivery.

Zurich, Canton of Zurich, Switzerland