Groundbreaking new research could reshape mental health care in the UK and beyond
Compass Pathways’ COMP360 is a synthetic psilocybin therapy that could become the first psychedelic-based treatment for depression approved in the UK.
This groundbreaking therapy is aimed at helping patients with treatment-resistant depression (TRD) who haven’t found relief with standard antidepressants.
Recent clinical trials have delivered promising results, and UK regulators have even put COMP360 on an accelerated development path
A Silent Epidemic
Depression is everywhere. And it’s only getting worse.
Globally, over 300 million people suffer from major depressive disorder (MDD), making it the leading cause of disability worldwide.
And for roughly one-third of those people, standard treatments like antidepressants simply don’t work. This is what’s known as treatment-resistant depression (TRD).
TRD is more than just persistent sadness. It’s a condition linked to:
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Higher suicide risk
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Poorer quality of life
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Chronic fatigue and brain fog
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Increased risk of other illnesses
For decades, the options have been limited. But now, a new approach is being tested. One that doesn’t require daily pills, and instead relies on a single, high-dose psychedelic session.
Enter COMP360: A Psilocybin-Based Therapy
COMP360 is a synthetic, pharmaceutical-grade form of psilocybin, which is one of the active compounds found in “magic mushrooms.”
Developed by mental health biotech company Compass Pathways, COMP360 is being studied as a guided therapy, administered in a clinical setting with trained therapists to support the experience.
Unlike traditional antidepressants that must be taken daily and often take weeks to kick in, COMP360 is designed to work differently:
One dose. One session. Months of relief.
So far, the science is incredibly promising.
What the Studies Have Found So Far
While there is a growing mound of research showing the antidepressant effects of psilocybin, Compass Pathways has been rigorously studying COMP360 in multiple trials.
Here's a breakdown of the key results:
✅ COMP001 (Phase IIb Trial)
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Included 233 people with moderate-to-severe treatment-resistant depression.
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Participants received a single dose of either 25mg, 10mg, or 1mg of COMP360 (with 1mg acting as a control/placebo).
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Results:
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The 25mg group saw a rapid and statistically significant reduction in depressive symptoms by week 3.
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Many participants continued to experience improvements for up to 12 weeks.
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Importantly, the effects were substantially better than lower doses.
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🧬 COMP004 (Long-Term Follow-Up Study)
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Tracked how long participants remained free of depression symptoms after their session.
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Median time to relapse:
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25mg dose: 189 days (~6+ months)
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10mg dose: 43 days
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1mg dose: 21 days
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That’s a game-changer.
One session. Six months of relief, for people who hadn’t responded to any other treatment.
As Compass’ Chief Medical Officer Dr. Guy Goodwin said, these findings show the potential of COMP360 to offer rapid and durable benefits from a single administration.
The Final Test: Phase 3 COMP005 Trial
Now, Compass is in the middle of its most important study yet: the Phase 3 COMP005 trial. This is the final step before possible regulatory approval.
📌 Key Facts:
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258 participants with treatment-resistant depression
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Conducted at 32 sites across the United States
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Participants received a single dose of 25mg COMP360 or a placebo
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The study is randomised, double-blinded, and placebo-controlled - the gold standard for clinical trials
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Dosing is now complete, and the 6-week results will be revealed in late June 2025
This trial is the largest study of synthetic psilocybin for depression ever conducted. And it could soon become the first to show definitive, regulatory-grade evidence for its efficacy.
Why These Results Matter
If the COMP005 results are positive, this could be a watershed moment in mental health treatment.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted COMP360 an Innovation Passport under its Innovative Licensing and Access Pathway (ILAP).
ILAP is designed to accelerate the development and review of promising medicines, facilitating faster patient access.
This fast-track status signals that regulators view COMP360 as a high-priority innovation.
In practice, ILAP designation could help COMP360 reach patients sooner, assuming the upcoming Phase 3 data confirm its safety and effectiveness.
This could herald a new era in mental health care - a fast-acting, long-lasting treatment option for patients who haven’t been helped by existing antidepressants.
COMP360’s success would not only validate psychedelic therapy as a legitimate medical approach, but also potentially pave the way for broader acceptance of psychedelic medicines in mainstream healthcare.
A Mushies Perspective
While we don’t sell psilocybin at Mushies, we’re passionate about natural medicine, brain health, and reconnecting to the intelligence of the body and mind.
We believe that:
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Mushrooms can teach us something essential about healing.
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Real change doesn’t always come from more pills, but from deeper alignment.
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The future of mental health lies in root-cause healing, not band-aid solutions.
Whether it's Lion’s Mane for supporting your nervous system, or a clinically guided psilocybin session for helping people out of deep depression, mushrooms have a role to play in reconnecting us to ourselves, our nature, and our health.
📅 What’s Next?
We’re now just weeks away from the COMP005 Phase 3 results, expected in late June 2025.
If the results are positive, it will mark the first time a psychedelic medicine has been approved for depression in modern history.
We’ll be watching closely. And when the data drops, we’ll break it down in plain English for our readers and community.
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Final Thought
It’s rare that one clinical trial could change how we understand - and treat - something as widespread and devastating as depression. But this might be one of those moments.
Nature, science, and human healing are beginning to align. And the results could be transformational.
