Psychedelics: Therapy proposal for bipolar disorder – 12/12/2023 – Virada Psychedelica

The list of affective disorders with potential for psychedelic treatment has just expanded a little more, with the incorporation of bipolarity among its experimental targets. Not bipolar type 1, which is more exuberant, but bipolar 2, in which episodes of mania can even go unnoticed.

The clinical trial sponsored by the company Compass Pathways tested a single dose of synthetic psilocybin (25 mg) in 15 patients experiencing a depressive phase of at least three months at recruitment. There were 9 women and 6 men, most of whom had been depressed for more than two years.

Three months later, 12 of the volunteers were in remission. In other words, they scored less than 10 points on the standardized MADRS (Montgomery-Åsberg Depression Rating Scale). The results are in an article published in the journal of the US Academy of Sciences, JAMA.

There were no serious adverse effects during the experiment, only mild symptoms, such as headache. No episodes of mania, psychotic episodes or suicidal ideation. A correlation was observed between the intensity of the psychedelic experience (change in consciousness) and the measured therapeutic benefit.

The study, conducted at Baltimore’s Sheppard Pratt Hospital by Scott Aaronson of Columbia University, was supervised by Trisha Suppes of Stanford University. Compass provided funding and its COMP360 (psilocybin) product, but would not have directly participated in the research.

The UK-based company is also the most advanced clinical trial with psilocybin for depression, in phase 3. It faces competition from the Wisconsin-based Usona Institute, which is a non-profit and advocates for limits on intellectual property on naturally occurring psychedelics. , as opposed to Compass’ controversial strategy.

There are doubts about whether the COMP360 formulation is truly innovative, to the point of justifying the granting of patents. The product would not be different from psilocybin mushrooms Psilocybe cubensiswhich is born in cattle manure and is sold online in Brazil, or Mexican Psilocybeconsumed for centuries by traditional populations in Mexico, such as the Mazatecs.

With the retraction of investors in psychedelic companies, an expansion of Compass’ potential market would come in handy. It is estimated that bipolar disorder, a condition with few effective treatment options and which carries suicide rates between 5% and 15% of those diagnosed, affects 0.4% of the adult population (more than 1 million people, in the USA alone, or almost half a million, in Brazil).

The study in JAMA was small and did not have a double-blind placebo control group, in which neither participants nor experimenters know who took what. Even without this gold standard of biomedical research, its results are remarkable: 80% of bipolar patients in remission three months after a single dose of medication will seem like a dream to patients and their psychiatrists.

The authors themselves, however, emphasize that this outcome cannot be extrapolated to all bipolar patients. In addition to the small sample, which may contain selection bias, they were careful to choose a subgroup less prone (bipolar 2) to intense manic episodes, which could lead to psychotic episodes under the influence of psilocybin.

In other words: it is not recommended that anyone with this disorder self-medicate by purchasing mushrooms online, much less ingesting them in the absence of reliable and sober people. If in doubt, talk to your doctor.

Furthermore, the trial took place in a controlled environment and included at least 6 hours of psychotherapy, that is, intense supervision. It took 3 hours to prepare the volunteers, before dosing with psilocybin, and another 3 sessions to elaborate the contents raised during the psychedelic effect. Not to mention the 8-9 hours of travel with therapists present the entire time.

This system of psychedelic-assisted psychotherapy (PAP) involves two difficulties. First, regarding the gold standard required by regulatory authorities: it is difficult, if not impossible, to discern what would actually be causing the therapeutic benefit, whether the drug itself or the concomitant therapy.

Defenders of PAP would say that this question makes no sense, as deep psychic experiences are being examined, whose integration by the psyche will always be facilitated by the participation of experienced therapists. By simply comparing, it would be like trying to invalidate the benefit of certain surgeries because the cure and recovery of the operated patient also depend on subsequent physiotherapy.

The second point is that PAP, being intensive in specialized labor, has everything to become expensive and not very accessible to those who would need it, if and when it is regulated. In places where similar schemes are starting to be implemented, such as in the state of Oregon (USA), where more than 600 people have already sought psilocybin from accredited services, the cost of three sessions (preparation, dosage and integration) is around the US $3,000 (almost R$15,000).

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NOTICE TO NAVIGATORS – Psychedelics are still experimental therapies and, certainly, do not constitute a panacea for all psychological disorders, nor should they be the subject of self-medication. Speak to your therapist or doctor before venturing into the area.

About the trend towards legalizing the therapeutic and adult use of psychedelics in the USA, see the report “Free Mushrooms” in the December 2022 edition of Piauí magazine.

To learn more about the history and new developments in science in this area, including in Brazil, look for my book “Psychonauts – Travels with Brazilian Psychedelic Science”.

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