Psilocybin Clinical Trials Approved by FDA

FDA Approves COMPASS Pathways’s Psilocybin Clinical Trials

The United States Food and Drug Administration (FDA) has approved COMPASS Pathways’s clinical trials using psilocybin for treating depression, namely “Treatment Resistant Depression” (TRD).

In a statement released by COMPASS Pathways, 216 patients with treatment-resistant depression will take part in 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 government’s 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’ 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 is 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 by “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 our article on the Entourage Effect which discusses the 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.”

40 thoughts on “Psilocybin Clinical Trials Approved by FDA

  1. mitchell martin Reply

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

  2. Joe Cherubin Reply

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

  3. Joanne Oake Reply

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

  4. HMac Reply

    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!

  5. Bora Reply

    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

  6. Jesi Reply

    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.

  7. Nick Reply

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

  8. jake morgan Reply

    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.

  9. Virginia Reply

    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.

    • Staff Scientist Post authorReply

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

  10. Jolene Reply

    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 authorReply

      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.

  11. Cody Reply

    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.

  12. Robin Reply

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

  13. Liz Hodgess Reply

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

  14. Danny Burns Reply

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

    I would love to be part of a trial.

  15. Cathy (Kitty) Brochu Nobora Reply

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

    • Staff Scientist Post authorReply

      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?

  16. Philip Ehlen Reply

    I’ll have to break loose from my depression to join a clinical study. The last study I joined for a different problem ended up saving my life. I believe this study could make my life mean something again. I’m ready to sign up.

  17. AD H Reply

    I have tried many possibilities for depression and anxiety, without much success. Is there a trial I could investigate?

  18. Randy Moody Reply

    I would really appreciate to participate in trials as ive tried many different anxiety/depression meds for years and still struggle everyday thank so much.

  19. David Hatch Reply

    I am interested in participating in a psilocybin, clinical trial. I live in Orlando , Florida.

  20. Steve Lenavitt Reply

    Have been on depression meds for 17 yrs. now (high doses, at times) and they just don’t seem to do much (if anything) anymore. Am very interested in participating….

  21. billy Reply

    Legend has it that Penis Envy originated from an exceptionally large and healthy mushroom found deep in the Amazon Rainforest, by fabled ethnobotanist, mystic, psychonaut, lecturer, author, and advocate for the responsible use of naturally occurring psychedelic plants, Terrence McKenna.

    buy shrooms online Canada

  22. jeff Reply

    Additionally, they are notoriously difficult to cultivate, as they possess characteristics like an underdeveloped cap and often the lack of a velum (veil) separating cap and stem, which results in light/ineffective sporulation. This difficulty-barrier to Penis Envy cultivation, along with the intensified experience that Penis Envy Shrooms provide has made the variety especially rare and desirable, however as Psilocybin mushrooms gain popularity Penis Envy is sure to become known as the preeminent variety to choose if you are looking for a more euphoric and distinctly visual mushroom experience.

    buy shrooms Canada

Leave a Reply

Your email address will not be published. Required fields are marked *