Psilocybin Clinical Trials Approved by FDA

FDA Approves COMPASS Pathways’s Psilocybin Clinical Trials

The United States Food and Drug Administration has approved Compass Pathways’s clinical trials directed to using psilocybin for treating depression, namely “Treatment Resistant Depression,” aka “TRD.”

In a statement released by Compass Pathways, 216 patients with treatment-resistant depression will take part in a phase two clinical trial across 12 to 15 research sites in North America and Europe, which will start in the U.K. later this month. The clinical trial is a dose-ranging study, which aims to determine the best dose of psilocybin to use for treating TRD.

The U.S. FDA’s approval of Compass’s trial represents a significant departure from the the governments position that psilocybin, cannabis, and MDMA are “substances, or chemicals … with no currently accepted medical use and a high potential for abuse.”  See DEA Drug Scheduling.  For many, this is perceived as the first step in correcting mistakes made in scheduling several promising drug treatments.

Compass Pathways’s Clinical Trials

As we reported previously, Compass Pathways is partnering with Worldwide Clinical Trials in conducting the first clinical trials for treating “Treatment Resistant Depression” (“TRD”) with psilocybin-assisted psychotherapy.  See Financial Times, September 20, 2017.

The first round of clinical trials are focused on “Dose Finding,” which means determining the correct dosing regimen for treating TRD. The clinical trial participants “will be given synthetic psilocybin” in trials designed to determine the best dose of psilocybin–whether 1 mg, 10 mg, or 25 mg – is most effective.

Notably, Compass’s study is measuring the effects of a known amount of a known drug.  Accordingly, the Compass studies already represent a significant improvement over existing psilocybin dosing methods, which rely on eating magic mushrooms.  (Magic mushrooms contain many active ingredients in variable concentrations).  See “Compass Pathways is NOT giving Magic Mushrooms to Depressed Patients.”  

Significant Step Forward in Establishing Baseline Benefits

The effects provided from “magic mushrooms” arise from combining multiple different active ingredients to arrive at an “entourage effect.”
To understand the full potential of psilocybin derivatives, the community must first understand how each piece works in isolation. Compass Pathways is leading the charge towards understanding the first piece.

These studies by Compass Pathways represent a significant first step towards creating psilocybin based formulations.  Improving our understanding of pure synthetic psilocybin treatments provides a baseline for studying formulations that leverage the full potential of magic mushrooms. See Entourage Effect (discussing synergistic benefits of psilocybin derivatives and drawing an analogy to cannabis research).  Akin to cannabis, once scientists have a baseline for how one component works in isolation, the community can quantify the benefits of specific combinations having optimized benefits and/or reduced side-effects.

Statements from Compass Co-Founders

George Goldsmith, Chairman and Co-founder of COMPASS Pathways, said, “We are excited to be starting this landmark trial which has the potential to transform lives. Depression is the leading cause of ill-health and disability worldwide, and treatment-resistant depression affects more than 100 million people. It is a huge unmet need and the trial will teach us more about how this new approach might address it.”

Ekaterina Malievskaia, Chief Medical Officer and Co-founder of COMPASS, said: “The design of this study has been a truly collaborative effort, with scientists, clinicians, patient representatives and regulators from Europe and North America working together with the goal of helping patients suffering with treatment-resistant depression.”

31 thoughts on “Psilocybin Clinical Trials Approved by FDA

  1. mitchell martin

    If you are doing studies on the effects on depression i would love to volunter

  2. Joe Cherubin

    Though I don’t suffer from depression in general, I’d still be a willing subject in any psilocybin research.

  3. Mark Carpenter

    How do I become eligible for the clinical trials?

  4. Jose Guijarro

    I will like to be par of the psilocybin study

  5. Joanne Oake

    Yes, it’s well past time to correct the mistaken drug laws. Hurry up!

  6. HMac

    How do I sign up? I have multiple diagnoses and would love to try this and pray it solves the life long struggle that I have had!

  7. Bora

    Psilocybin is mushroom and alive being.
    That stuff on picture is looks not alive, is that dead or what? for to doo what? better ecology? :O

  8. Jesi

    Sounds like an awesome break through for treating depression and other similar conditions. Does/is the company Compass offer an stocks we can buy into? Keep up the good research.

  9. Nick

    I would be very interested in being part of the trial if subjects are needed

  10. christopher M

    count me in. id gladly do my part in the search for knowledge.

  11. jake morgan

    i would love to b involved. my girl and i both have horrible ptsd anxiety and depresion fromnsome bad tramatic experiencess. this could save our lives. we are cpurently on methadone which has saved our li ses but we need somthing more for the mental side of things please we need help.

  12. Virginia

    I am interested in being apart of the study. I have stress, and can be very anxious. I have read about the benefits if psilocybin in small doses, and have been interested for some time now.

  13. Psuedohoax

    I’ve tried ketamine therapy. How would this compare?

    • Staff Scientist Post author

      Different drug. And a synthetic drug. The only real similarity would be that they are both alternatives to the presently accepted treatment methods.

  14. Jolene

    Why not use the real thing , not a synthetic. Looks like if they use a synthetic , thats a good way to get wrong results . am I the only one who does not trust the government / Big Pharms ?

    • Staff Scientist Post author

      Jolene – You are not the only person who has been let down by ***some*** of the practices of “big pharma.” However, let’s try not to lose sight of some things that pharmaceutical companies do very well — like making pure, precise dosage forms of drugs.
      To your point about “the real thing,” yes, naturally occurring mushrooms are wonderful. But, helping the 300,000,000 people with depression will likely take more than just mushroom fruiting bodies. Some people will probably prefer a more conventional dosage form having a known amount of known molecules.
      Ideally, we can work towards the best of both worlds — a reliable dosage formulation that also includes the combinations of natural molecules that Mother Nature puts into naturally occurring mushrooms. Just like we’ve seen with cannabis, synthetic THC does not provide the same benefits as taking combinations of multiple cannabinoids and/or terpenes. Focussing only on synthetic psilocybin would likewise overlook the benefits of the other molecules in mushrooms. This would be akin to missing out on CBD in cannabis as a result of focusing only on THC.
      Bottom line: It’s probably not an either/or situation but rather a combination of the two perspectives.
      In any event, thank you for your comments.

  15. Cody

    How can you register for the trials? I feel like this could potentially be incredibly beneficial for me and would love to participate and be a part.

  16. Robin

    I’m interested. Major Depression and ptsd from terrible life experiences.

  17. Liz Hodgess

    BopBipolar 2 and fibromyalgia, aged 49 in Australia, TO SAVE MY LIFE, ILL BE A GUINEA PIG PLEASE!!!!

  18. Danny Burns

    I have been micro-doseing for several years with great success.

    I would love to be part of a trial.

  19. Cathy (Kitty) Brochu Nobora

    I don’t see where anyone answered our questions about where to sign up. Cathy Brochu

    • Staff Scientist Post author

      Hi Cathy – Psilocybin Technology is only a site dedicated to providing good, factual information. We do not conduct clinical trials. You may want to reach out to COMPASS pathways?

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