1. Psilocybin-assisted therapy for depression (MDD and TRD) is finishing phase II clinical trials and may become a licensed therapy as early as 2025.
  2. Academic studies conducted around the world using psilocybin with accompanying psychological support (PAT) are demonstrating rapid and long-lasting positive effects on patients suffering from depression and anxiety. In one study the positive effects were still evident up to four and a half years later.
  3. Next to health care reimbursed therapies, decriminalisation efforts are opening another avenue through which psilocybin, ‘magic mushrooms’, can become a tool for the improvement of mental well-being.

Psilocybin is a psychedelic that can be derived from over 200 varieties of fungi. Since its isolation in 1958 by Albert Hofmann, a variety of synthetic methods for producing psilocybin have been found. A human body quickly metabolises psilocybin into psilocin which is the pharmacologically active agent which interacts with several serotonin receptors in the brain. Specifically, it is best known for being a 5-HT2a agonist, meaning it can change serotonin activity in the human brain and disrupt dysfunctional brain connectivity. Through these and other mechanisms, psilocybin thus offers a potent new alternative for the treatment of a wide variety of mental health conditions.

Clinical trials and research

Psilocybin is, after ketamine, the second most studied psychedelics to date. There have been 64 clinical trials to date of which 26 are phase II studies. The trials with psilocybin are for the widest range of mental health disorders. The following is a list of conditions for which psilocybin has potential therapeutic benefits based on clinical trials and academic studies conducted to date:

  • Depression (MDD, TRD, and bipolar);
  • Anxiety and depression in patients with life-threatening disease;
  • Social anxiety for those with autism;
  • Substance misuse, including alcohol, opioid and nicotine dependence;
  • Eating disorders such as anorexia nervosa;
  • Demoralisation in long-term AIDS survivors;
  • Cluster headaches/migraines; and
  • Symptoms of obsessive-compulsive disorder (OCD).

In these 64 clinical trials, nearly 2,100 patients have been enrolled, as of July 2021. Among the active trials are those investigating psilocybin for the treatment of migraine headache, psilocybin for the treatment of OCD, and psilocybin-assisted treatment of alcohol dependence. Most of these studies are either taking place in the US or Europe, as is the case for the other key psychedelics.

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