The FDA has granted breakthrough designation for psilocybin-based clinical trials for treatment-resistant depression. This exciting development recognizes that the psychedelic compound psilocybin — a Schedule 1 drug — may be a viable alternative to conventional drug-based treatments for serious mental illnesses when used under carefully controlled conditions. The therapy has superficial similarities to the practice of microdosing mushrooms, where researchers use tiny doses of psilocybin to improve sleep patterns.
What Is Psilocybin, and How Does It Work in the Brain?
Psilocybin is a chemical compound found in certain types of mushrooms, often known as magic mushrooms. From a chemical perspective, psilocybin is a tryptamine alkaloid with hallucinogenic properties. These mushrooms grow naturally in North America and Central America.
When a person consumes these mushrooms, the body converts the psilocybin into psilocin, a psychoactive chemical that has an effect on the brain similar to LSD. Psilocin disrupts communication between networks in the brain, causing them to lose synchronization with each other. These changes primarily affect the brain’s default mode network, responsible for internal thoughts and the perception of self, time and space.
These changes can persist for up to 3 weeks, even after other brain activity returns to normal. Therapists believe these persistent changes offer a therapeutic opportunity to help the brain return to a healthier state. Like other psychedelics, psilocybin may cause a range of experiences, from mild dissociation to psychosis and panic attacks.
Synthetic Psilocybin
This form of psilocybin is synthesized in a laboratory. While the process is expensive, it allows scientists to accurately measure the purity and dosage of psilocybin.
Microdosing Mushrooms
The chemical is present in certain species of mushrooms found in tropical and subtropical areas. The most common species is the genus Psilocybe. The psilocybin dose in microdosing mushrooms varies considerably.
Emerging Research and Clinical Trials on Mental Health Benefits
Following the FDA’s breakthrough approval of psilocybin trials, several organizations have performed research into using psilocybin for the treatment of various mental health conditions. In particular, clinical trials have demonstrated the effectiveness of psilocybin-assisted therapy in helping people with major depressive disorders.
In one 6-week clinical trial, 51 randomly selected adults with MDD were given a single 25mg dose of synthetic psilocybin and provided psychological support from psychologists and physicians specializing in MDD treatment. A second group received a placebo. The results of the study showed a 15.9% difference in remission rates after 6 weeks compared to patients taking the placebo drug niacin. Although the trial was a success, some patients didn’t respond positively to the treatment.
Another study, conducted by the biotechnology company Compass Pathways, divided 233 MDD patients into three groups. Each group received a single dose of psilocybin in one of three strengths: 1mg, 10mg and 25mg. This study showed similar improvements at the two higher dosages, although some patients experienced negative side effects.
Conditions Being Studied
While most efforts have focused on treating MDD, work has been done on using psilocybin for treating anxiety, PTSD and alcohol addiction. The Johns Hopkins Center for Psychedelic and Conscious Research says the drug, in conjunction with therapy, has been successful in treating:
- Major depression
- Alcohol use disorder
- Substance abuse
- Existential anxiety
- Smoking
The National Center for PTSD is funding research for the use of psychedelic compounds, including psilocybin, for the treatment of PTSD, used in conjunction with PTSD therapy.
How Psilocybin Therapy Is Administered in Clinical Settings
Clinical trials follow special protocols. Therapists are licensed and have special training in psilocybin-assisted therapy. Before treatment, they meet the participant, get to know them and form a relationship of trust. They explain the therapy and describe what will happen and how the patient will feel. Participants must be comfortable with the therapy.
The session normally takes place in a specifically designated room that’s warm and comfortably furnished. Therapists use curated music to help the participant relax. It’s common to provide patients with an eye mask to help them focus internally and not be distracted by their surroundings.
Once the drug is administered, the psilocybin experience lasts up to 8 hours. The therapist is present throughout the session, providing comfort and support. They’re on hand to help the participant move around, use the bathroom and stay hydrated. Light snacks are normally provided.
After the session, the participant is discharged into the care of someone who understands their treatment. The therapist conducts follow-up therapy the next day and periodically over the following weeks. The participant is encouraged to discuss their experiences during the session.
Legal Status and Access in the United States
Although the FDA has granted a breakthrough designation for using psilocybin in clinical trials, the drug remains a Schedule 1 controlled substance. This status allows researchers to conduct approved clinical trials.
Several states and jurisdictions have decriminalized psilocybin for certain applications:
- Oregon. The state allows psilocybin therapy by licensed facilitators.
- New Mexico. In 2025, the state approved a law decriminalizing the drug for supervised medical use.
- Colorado. The personal use and possession of psilocybin is allowed.
- New Jersey. A bill to decriminalize psilocybin is under consideration
- Jurisdictions. Cities, including Washington, DC, Seattle (WA), Detroit (MI), Oakland (CA), Santa Cruz (CA) and Somerville (MA) have decriminalized the drug.
While FDA-approved trials using psilocybin are legal, the private possession of magic mushrooms is typically illegal. Exceptions include Colorado and some cities. In other jurisdictions, individuals may face severe penalties for the possession and cultivation of magic mushrooms.
The Future of Psychedelic-Assisted Mental Health Treatment
Although more research is needed, there are strong indications that psychedelic-assisted therapy will be recognized as an effective alternative treatment for mental health issues. In 2024, the FDA approved a breakthrough therapy for an LSD-based anxiety treatment, while an application to use MDMA (Ecstasy) for PTSD treatment was approved in 2017.
While there are still many barriers, it seems it’s only a matter of time before the concerns about safety and efficacy are allayed. Researchers believe that once more studies are completed, specific psychedelic treatments will receive FDA approval for treatment-resistant mental health conditions.
Getting Mental Health Help in Florida
The use of psychedelic mushrooms for depression treatment is an exciting future possibility. But there are many other options for mental health treatment, including neurotherapy. If you’re struggling with MDD or other mental health issues, contact us now at Sun Health Center. Our compassionate counselors will explain how we can help.
