Health & Wellbeing

Psilocybin therapy 4 times more effective than antidepressants, study finds

Psilocybin therapy 4 times mor...
The latest research into psilocybin therapy as a treatment for depression has yielded promising results
The latest research into psilocybin therapy as a treatment for depression has yielded promising results
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The latest research into psilocybin therapy as a treatment for depression has yielded promising results
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The latest research into psilocybin therapy as a treatment for depression has yielded promising results

A new study is presenting the first published data from preliminary human trials investigating the effect of psilocybin-assisted psychotherapy to treat major depressive disorder (MDD). The incredibly positive results have been described as just a “taste of things to come” with larger a Phase 2 trial well underway.

The US Food and Drug Administration (FDA) has granted psilocybin, the primary psychoactive compound in magic mushrooms, a Breakthrough Therapy designation on two occasions over the past 24 months. Initially the designation was granted to help accelerate trials for severe treatment-resistant depression, but more recently the classification focused on trials for major depressive disorder.

Over the last few years promising preliminary research has shown psilocybin to potentially be effective in helping terminal cancer patients manage end of life anxiety. Initial psilocybin trials focusing on depression concentrated specifically on treatment-resistant depression – a clinical classification that categorizes patients suffering from MDD who have not responded effectively to at least two different pharmacological antidepressant treatments during a current depressive episode.

MDD is much more common, with some estimates suggesting over 300 million people worldwide suffer from the debilitating condition. While a larger Phase 2 trial testing psilocybin for MDD is currently underway, this new study, in the journal JAMA Psychiatry, offers the first peer-reviewed published data showing efficacy for this particular mental health condition.

This small preliminary trial recruited 24 subjects with at least two-years documented history of depression. All subjects were required to wean off any anti-depressant treatment before the trial commenced.

Depression was assessed using the standard GRID-Hamilton Depression Rating Scale. Severe depression scores 24 or higher on the scale, while seven or less is classified as no depression. At the beginning of the study the average score for the cohort was 23.

The treatment process resembled the general protocol used in most psilocybin studies. Two doses of psilocybin were administered to each subject, spaced two weeks apart. A number of psychotherapy sessions both preceded and followed the active psilocybin sessions.

The results were undoubtedly impressive with 71 percent of the cohort displaying more than a 50 percent reduction in depressive symptoms at the four-week follow up. The average depression score for the cohort had dropped from 23 to 8 a month later, and more than half of the group were considered to be in remission.

“The magnitude of the effect we saw was about four times larger than what clinical trials have shown for traditional antidepressants on the market,” says Alan Davis, from the Johns Hopkins University School of Medicine and corresponding author on the study. “Because most other depression treatments take weeks or months to work and may have undesirable effects, this could be a game changer if these findings hold up in future ‘gold-standard’ placebo-controlled clinical trials.”

The study is not without its limitations. It’s a small sample, with no placebo control, so clearer data from larger trials are certainly important. Plus, only a short follow-up period limits the ability to understand the longer-term benefits of the therapy.

However, psychedelic research pioneer Roland Griffiths suggests it is impressive to see these kinds of results from a broad population of MDD patients. Prior psilocybin studies have focused on narrow mental health conditions such as terminal cancer patients, but MDD is a more general condition with a wide variety of manifestations.

“Because there are several types of major depressive disorders that may result in variation in how people respond to treatment, I was surprised that most of our study participants found the psilocybin treatment to be effective,” says Griffiths.

Philanthropist Tim Ferriss, who financially supported this preliminary study, calls this new research a “critically important proof of concept.” A well-known advocate for psychedelic medicine, Ferriss says these promising results are only the beginning of a major paradigm shift in mental health treatment.

“How do we explain the incredible magnitude and durability of effects?” asks Ferriss. “Treatment research with moderate to high doses of psychedelics may uncover entirely new paradigms for understanding and improving mood and mind. This is a taste of things to come from Johns Hopkins.”

A seven-site Phase 2 trial currently underway is testing the efficacy of a single psilocybin dose (bookended by several psychotherapy sessions) in a larger cohort of MDD subjects. Coordinated by a non-profit research organization called the Usona Institute, the trial is hoped to reach completion sometime in 2021. And with the help of the FDA’s Breakthrough Therapy designation, positive results should lead to a rapid move into final Phase 3 trials.

The new study was published in the journal JAMA Psychiatry.

Source: Johns Hopkins Medicine

9 comments
FB36
IMHO, drugs which do not easily cause overdose deaths (like THC, LSD, Psilocybin etc) legally should/must be treated same as alcohol (which is really just another (similar) kind of drug)!

IMHO, just like prohibition of alcohol had caused so much crime in the past (& that is why it was repealed many years later), prohibition of many similar drugs are causing so much crime today! We need to take lesson from history!
guzmanchinky
I will be heading to Amsterdam this summer (if it's allowed) to participate in one of the several clinics there offering week long psilocybin treatment programs. Why can't we have those here?
michael_dowling
FB36: I think the difference between alcohol and the illegal hard drugs is that the former was socially acceptable before Prohibition,whereas the hard drugs were seen as mainly used by society's undesirables.
jerryd
2 states just legalized it along with 4 new recreational cannabis ones .
I found it to be by far the best of these kind of drugs as not pushing like the others, a much more mellow trip with good body high feelings and great visually but no paranoia the others can generate.
I see no reason for it to be illegal as all these are not anywhere near as bad as alcohol, a truly dangerous addicting violent drug .
stevendkaplan
Well now that Oregon just legalized psilocybin therapy this week this therapy should see some pretty fast implementation.
informed_skeptic
Saying that psilocybin is 4x more effective in the title of this article is misleading. They did not directly compare psilocybin to antidepressants, rather the researcher quoted was comparing the effects in this study of 27 participants with the average effect size from a whole bunch of huge antidepressant trials. This is a pretty tenuous comparison because a lot of factors specific to this psilocybin trial (primarily sample characteristics) as well as random chance may be responsible for the strong results. It is not uncommon to see large effects in small studies for novel treatments, and then results end up looking more modest as larger, higher quality studies are done. So to truly say its four times more effective you'd need to randomly assign participants to antidepressants vs. psilocybin and show the same differences in effects.
1stClassOPP
I taught school children for many years that the use of marijuana is not desirable because it was viewed as a “gateway “ drug leading to usage of much more potent drugs. I guess I wasted my time by doing so. The problem I see is that there will be a need for more and more of the drugs that help you temporarily enjoy a “high”.
Daishi
@informed_skeptic This was addressed in the article with the statement "The study is not without its limitations. It’s a small sample, with no placebo control, so clearer data from larger trials are certainly important.". And even the headline didn't say it as a factual statement it simply attributed the findings to a single study which most informed readers know to take with a grain of salt so I feel that it met journalistic integrity. And yes, as others have mentioned legalization should pave the way for larger more comprehensive studies.
Rusty Harris
Gee, you mean a NATURAL resource, might be safer than some chemical compound cooked up in a big pharmacy lab??