Psilocybin, the active ingredient in magic mushrooms is being fast-tracked by the FDA for the second time in just over a year. Designated as “Breakthrough Therapy,” the FDA believes that this compound shows strong preliminary evidence in treating depression.
Depression, technically known as major depressive disorder (MDD), is being targeted by Usona Institute, a non‑profit, medical research organization, whose mission is to conduct and support pre-clinical and clinical research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines. Their focus is on alleviating depression and anxiety in people for whom current medical treatments fall short in offering relief and a better quality of life.
Usona’s phase 2 clinical trial aims to determine the efficacy of treating depressed patients with single, one-time oral doses of psilocybin. Protocol for this study includes: 1) a period of preparation with session facilitators prior to dosing; 2) administration of study medications in an aesthetically pleasing room under the supervision of two facilitators who are present throughout the session; and 3) three post-dose integration sessions during which participants are encouraged to discuss their intervention experience with the facilitators.
It will likely be several years before any therapies related to these trials hit the market.
In October 2018, the FDA granted a Breakthrough Therapy designation to COMPASS Pathways for its use of psilocybin in addressing treatment-resistant depression (TRD). As the name suggests, this condition is defined by depressive symptoms that don’t improve with the use of two or more standard therapies. Also, in March 2019, the FDA approved a TRD nasal spray, esketamine (sold as Spravato) which is designed to mimic the positive effects of the hallucinogenic ketamine, as the first new antidepressant in decades.
A small 2017 study found that psilocybin treatment decreased activity in the amygdala, a region of the brain that helps regulate fear and anxiety. Dysfunction in the amygdala has been noted in patients with Alzheimer’s, PTSD, and Autism Spectrum Disorder. In theory, this hallucinogenic compound could serve to calm negative emotions and prepare patients to gain more valuable insight and long-term effects from therapy. However, possible side effects can include dizziness, nausea, vomiting, paranoia, and frightening hallucinations, so taking them in a controlled setting is crucial to their therapeutic use. Hallucinogens are not recommended for individuals with a family history of schizophrenia, as there is some concern they might trigger psychotic episodes in people prone to them.
You should not attempt to self-medicate with “shrooms” for several reasons: 1) it is illegal to cultivate or possess psilocybin-producing fungi in the United States; 2) it’s easy to accidentally ingest poisonous fungi that look similar if you don’t know what you’re looking for; and 3) the powerful emotional effects of a hallucinogenic trip can backfire without the help of an expert to guide you.
Usona Institute is currently recruiting for this MDD study through Spring 2021.