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Government Medicine United States

Psilocybin For Major Depression Granted Breakthrough Therapy By FDA 89

Posted by BeauHD from the psychedelic-drug-research-community dept.
An anonymous reader quotes a report from New Atlas: The US Food and Drug Administration (FDA) has granted psilocybin therapy a Breakthrough Therapy designation for the second time in a year, this time with a view on accelerating trials testing its efficacy treating major depressive disorder (MDD). This new FDA Breakthrough Therapy approval focuses on a seven-site, Phase 2 trial currently underway in the United States. Coordinated by a non-profit research organization called the Usona Institute, the trial is exploring the antidepressant properties of a single psilocybin dose in treating patients with major depressive disorder.

Last year's Breakthrough Therapy designation was targeted at the drug's efficacy for treatment-resistant depression (TRD). That particular clinical classification categorizes patients suffering from MDD who have not responded effectively to at least two different pharmacological antidepressant treatments during a current depressive episode. It is estimated between 10 and 30 percent of MDD patients fall into the category of TRD. The new FDA approval focuses on Usona's research into the broader condition of MDD, characterized by episodes of severe depression that last more than two weeks. Hundreds of millions of people around the world suffer from these kinds of acute major depressive episodes every year. "The Usona Phase 2 trial plans to enrol 80 subjects, randomized to receive either a single active dose of psilocybin or an active placebo containing niacin," the report adds. "The methodology being trialed is similar to other psilocybin therapy studies, with a number of preparatory psychotherapy sessions preceding the active psychedelic dose, and a number of integrative psychotherapy sessions afterwards." It's estimated that the current Phase 2 trial will be completed by early 2021, where it should be able to move into larger Phase 3 trials if the results are positive.

The FDA also gave psilocybin therapy a Breakthrough Therapy status late last year. These trials should be completed sometime in 2020, "suggesting the next 12 to 24 months will offer some compelling and solid data into how effective this new psychedelic therapy actually is in treating several different forms of depression," reports New Atlas.
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Psilocybin For Major Depression Granted Breakthrough Therapy By FDA More

Psilocybin For Major Depression Granted Breakthrough Therapy By FDA

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  • The folks that get the niacin shots will be more depressed after the treatment.

    • Re: (Score:2)

      by Mashiki ( 184564 )

      Niacin gives you a short-term pick-me-up which is why it's used in energy drinks. I'll be more interested when the FDA allows the shroom trials for migraines.

      • "Niacin gives you a short-term pick-me-up"

        High doses 500-2000mg gives you a rash that people think you're going to explode. All the small blood vessels dilate.
        But you get used to it.

      • How short term is this pick-me-up effect?

        • How short term is this pick-me-up effect?

          Two to four hours.

          Be a little careful: niacin can cause "niacin flush" which can make your skin fell like it's on fire. The effect is harmless, but it doesn't feel harmless.

          Different people are flushed to a larger or lesser degree, and your body eventually gets used to the effect. A big first-time dose can be quite scary.

  • Comment removed (Score:3)

    by account_deleted ( 4530225 ) on Tuesday November 26, 2019 @07:10PM (#59460050)
    Comment removed based on user account deletion

  • Still nothing for minor depression? What about Concerts? Back ache?

    • Still nothing for minor depression? What about Concerts? Back ache?

      Check out "The Mood Cure" by Julia Ross. She identifies 4 broad categories of depression caused by deficiencies in specific neurotransmitters in the brain, and includes a questionnaire so you can distinguish which type of depression you have.

      Once you have determined your depression type, you can bolster your diet with foods and supplements that the body will convert into that neurotransmitter to help alleviate the symptoms.

      (It's a little more complicated than that, but not much. The book goes over the theor

      • That sounds like pseudoscience at first glance until the long term memory kicks in. Even if it do work, it sounds like you need lots of spare time for it. There is also the issue of the body being capable of the conversion. If you have low Serotonin it might be because the body have an issue with the Serotonin production. So even if you eat lots of food that contain Tryptophan it just doesnt have a big impact. So taking Serotonin in pill form is still the best way to be sure you get it.

        Speaking of Tryptopha

  • If the alternative is suicide I don't really mind but psychopharmacology is given far too much respect given how weak the science is.

    They should come with disclaimers with percentages for how likely and how much it is to help and how likely it is for you to wake up having murdered your family (ie. SSRIs).

    • If the alternative is suicide I don't really mind but psychopharmacology is given far too much respect given how weak the science is.

      They should come with disclaimers with percentages for how likely and how much it is to help and how likely it is for you to wake up having murdered your family (ie. SSRIs).

      If you're not already in marketing for a big pharma, you should be.

    • Or how likely you'll want to go to the basement, open the gas line, and flick your Bic.

      The problem is that we don't know how the brain works, especially with respect to the mind. If I were to compare our knowledge of the brain to our knowledge of the human genome then I'd guess that we haven't found the structure of DNA yet. That moment will be when we know how consciousness arises from a network of brain cells. But for the next few decades at least we'll be throwing spaghetti on the wall and seeing what st

    • If the alternative is suicide I don't really mind but psychopharmacology is given far too much respect given how weak the science is.

      They should come with disclaimers with percentages for how likely and how much it is to help and how likely it is for you to wake up having murdered your family (ie. SSRIs).

      You are 1000% correct.

      We've identified some knobs; but we don't even know which way to turn them, let alone how far.

    • Until we have some kind of comprehensive and complete molecular understanding of how the brain works, psychopharmacology will often remain a clinical and observational semi-science.

      I wish it was less subjective and more objective, but in dealing with issues like emotions, cognition, personality, social interaction -- these are subjective and culturally malleable concepts and so is "success" in improving a patient's outcomes.

      I'm definitely in favor of psychiatrists using what they and their colleagues thinks

  • Isn't one expected before the end of next year, especially if we keep having trade wars?

  • IMHO, just like prohibition of alcohol (which is just another type of drug) caused huge amount of criminal activities in the past, prohibition of many drugs causing huge amount of criminal activities today!!! We really need to take lesson from history!!!
    IMHO, drugs like psilocybin & LSD & DMT & THC should/must be legally treated same as alcohol!!!

    • Re: (Score:3, Insightful)

      by account_deleted ( 4530225 )
      Comment removed based on user account deletion
      • That comment has a single +1 Insightful mod right now, bringing it up to zero. That dude's posts start at -1, for good reasons.

        • Re: (Score:2)

          by aitikin ( 909209 )

          That comment has a single +1 Insightful mod right now, bringing it up to zero. That dude's posts start at -1, for good reasons.

          Curse you and pointing out facts. This is /., we don't do facts here!

    • How about being more realistic than calling Natural elements "drugs"... Alcohol has more cons than pros, when consumed by humans. Its two main offending reasons to not drink it:
      1) addictive
      2) can kill you (overdose)

      I say, as long as mother nature is providing it - as a result of billions of years of evolution - and it's not addictive nor can it kill you, it should be legal.

      Magic mushroom aren't called "magic" for no reason. They have been know to dramatically change people for the better. The worst thin

  • The placebo's not going to work (Score:3)

    by rgbe ( 310525 ) on Tuesday November 26, 2019 @07:45PM (#59460218)
    Psilocybin and other psychedelics have unmistakable effects that the patient will know they are not the placebo. I doubt the placebo will have the traditional effect.
    • Even at the doses under consideration? If it induces psychosis it's not going to fly as a therapy. Evaluating the side effects is as important as the efficacy itself.
  • Do they send patients home to take it, or do they keep them at the doctor's office? Would they have a priest or other religious teachers involved? One Johns Hopkins study I remember they said 100% of those participating reported a religious experience, so it's definitely something to consider.

  • Psilocybin should be sold over-the-counter (Score:5, Interesting)

    by MetricT ( 128876 ) on Tuesday November 26, 2019 @08:58PM (#59460454)

    My brother died from brain cancer last year, three months after he was diagnosed. I was cradling him in my arms when he died. That fucked me up in ways I cannot describe.

    I tried cannabis to deal with the depression, and while it helped, I had to take it every night, and I hated the foggy brain it gave me. I contemplated prescription antidepressants, but they have a long list of serious side-effects that I didn't want to touch with a stick.

    So I decided "What the hell...", got some shrooms, and took a 600 mg microdose. Holy shit. An hour later, I was wrapped in the sort of joy that had eluded me for over a year. And that was the only side-effect. I didn't spend hours talking to the space iguanas that live in my microwave or anything like that.

    And the next day, I felt *much* better. I took a few more doses every few weeks after that until I ran out. I'm not 100% again, and I may not ever be. But I'm a functional human being again thanks to psilocybin.

    Psilocybin is a pharmaceutical company's worst nightmare. It can't be patented, it's easily growable (if the law would allow), it doesn't have horrible side-effects, and it starts working in minutes instead of weeks.

    Given that it has a safety profile better than marijuana, which itself is an order of magnitude safer than *coffee*, there's no reason we shouldn't sell this OTC at Wal-mart. There are lots of depressed, suicidal, and hurting folks. It's a fucking crime against humanity that psilocybin is illegal.

  • diy psychotherapy (Score:4, Insightful)

    by David Kaminski ( 5867940 ) on Tuesday November 26, 2019 @10:47PM (#59460818)
    Psychedelics were life changing for me. After 20 years of chronic cannabis use and dysthymia I had some mdma and lsd one night and it's not easy to describe the actual experience without sounding like a mystic but I had a deep interoceptive experience of my mental and physical health problems. That awareness stayed with me in the following weeks and led me to quit smoking altogether and begin a regular exercise practice. The lifestyle changes had a profound effect on my mental health and I became more outgoing and socially active. I do think some pre-work with a psychotherapist who has experience with psychdelic integration would be a good thing for people with trauma and maybe it isn't going to work for everyone. But these are mostly harmless drugs that don't cause dependence with the potential to transform peoples lives.
  • but unfortunately not everyone responds to every psychadelic the same way. Some people respond better to lysergamides (LSD) (myself included) than tryptamines (mushrooms/ayahuasca) and I have friends that only respond positively to phenethylamines (cacti/mescaline). To decriminalize one for depression is like making zoloft legal but making prozac, welbutrin, and all other SSRIs illegal. All the classic psychadelics have long proven track records of being safe and completely, physically harmless. What I f

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