John Miller
The U.S. Food and Drug Administration (FDA) has designated psilocybin-based drugs for treating depression as breakthrough therapy. This means that the FDA has acknowledged the potential of psilocybin, the active ingredient in magic mushrooms, to substantially improve the treatment of major depressive disorder (MDD) and treatment-resistant depression (TRD). The FDA is expediting the development and research process of psilocybin-based treatments, with clinical trials already underway. While the potential benefits of psilocybin in treating depression are promising, it is important to note that it is not recommended for self-medication due to the potential risks involved.
| Characteristics | Values |
|---|---|
| FDA Breakthrough Therapy designation | Given to COMPASS Pathways in 2018 and Usona Institute in 2019 |
| FDA-approved treatment | Nasal spray for treatment-resistant patients based on Esketamine, a substance related to ketamine |
| FDA-approved drug | Epidiolex, derived from cannabis, as a treatment for epilepsy |
| FDA-approved therapy | Psilocybin-assisted psychotherapy for major depressive disorder |
| FDA-approved therapy | Psilocybin-assisted psychotherapy for treatment-resistant depression |
| Psilocybin side effects | Headache, nausea, anxiety, dizziness, elevated blood pressure, increased blood pressure and heart rate, fatigue, poor sleep, paranoia, persistent psychosis, and hallucinations |
| Psilocybin treatment | Administered once or twice in doses ranging from 10-30 mg |
| Number of patients | Over 2000 |
| Number of trials | Over 30 |
| Number of studies | 528 participants |
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What You'll Learn
FDA-approved psilocybin-based drugs
The U.S. Food and Drug Administration (FDA) has not approved any psilocybin-based drugs yet. However, in 2018, the FDA gave "breakthrough therapy" status to COMPASS Pathways for its use of psilocybin in addressing treatment-resistant depression (TRD). This status is designed to expedite the development and review of drugs and is only given to therapies that show strong preliminary evidence of treating serious medical conditions. The FDA is helping to speed up the process of researching and approving psilocybin, a hallucinogenic substance in magic mushrooms, to treat major depressive disorder (MDD).
In March 2019, the FDA approved a TRD nasal spray designed to mimic the positive effects of hallucinogenic ketamine. This was the first new antidepressant approved in decades. However, much is still unknown about this drug, including its long-term effects on the brain.
In 2019, the FDA granted a second "breakthrough therapy" designation to the Usona Institute, a nonprofit medical research group dedicated to understanding the therapeutic effects of psilocybin. Usona launched a Phase 2 clinical trial to determine the efficacy of treating depressed patients with single, one-time oral doses of psilocybin. This trial is expected to be completed by early 2021, and if successful, it will quickly move to a larger Phase 3 trial.
While psilocybin shows promise in treating depression, it is important to note that it is not without risks. Possible side effects include dizziness, nausea, vomiting, paranoia, and frightening hallucinations. Therefore, it is crucial that the use of psilocybin for therapeutic purposes is carefully monitored by experts in a controlled setting.
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Safety concerns and side effects
While the FDA has approved psilocybin-based drugs for treating depression, the side effects of consuming magic mushrooms cannot be ignored.
Psilocybin, the active ingredient in magic mushrooms, has been shown to have similar side effects to traditional antidepressant medications. These side effects may include headache, nausea, anxiety, dizziness, elevated blood pressure, paranoia, frightening hallucinations, and vomiting. These side effects are generally well tolerated and fade within 24 to 48 hours. However, it is crucial to consume psilocybin in a controlled setting to mitigate the risk of harmful effects.
The powerful emotional effects of a hallucinogenic trip can be challenging without the guidance of an expert. Additionally, it is easy to accidentally ingest poisonous fungi that resemble magic mushrooms if one is not knowledgeable about mushroom identification.
Furthermore, psilocybin is not recommended for individuals with a family history of schizophrenia due to concerns about triggering psychotic episodes. The potential long-term side effects and rare serious side effects of psilocybin use are still unknown and require further research.
While psilocybin shows promise in treating medication-resistant depression, it should be approached with caution. Professional supervision and monitoring are crucial when dealing with this potentially dangerous substance.
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Treatment-resistant depression
The U.S. Food and Drug Administration (FDA) has given "Breakthrough Therapy" status to psilocybin-based drugs for the treatment of major depressive disorder (MDD) and treatment-resistant depression (TRD). This status is designed to expedite the development and review of drugs that have shown strong preliminary evidence of being a substantial improvement over currently available therapies.
In 2018, the FDA granted this designation to COMPASS Pathways for its use of psilocybin in addressing TRD. The company's chairman and co-founder, George Goldsmith, stated that the FDA would be working closely with them to expedite the development process and increase the chances of getting the treatment to people suffering from depression as quickly as possible. The clinical trial was expected to take 12 to 18 months to complete.
In 2019, the FDA gave the Breakthrough Therapy designation for the second time to the Usona Institute, a non-profit medical research group dedicated to understanding the therapeutic effects of psilocybin. This second designation was for the treatment of MDD, which affects a larger population than TRD.
Psilocybin is the active ingredient in "magic mushrooms" and is known for its hallucinogenic and mind-altering properties. It has been found to profoundly impact the brain and have long-lasting effects on depressive symptoms. A small 2017 study found that psilocybin treatment decreased activity in the amygdala, a region of the brain that regulates fear and anxiety, and helped stabilize the default mode network, which is associated with self-reflection and thinking about others.
While psilocybin shows promise in treating depression, it is important to note that it should not be used for self-medication. The powerful emotional effects of a hallucinogenic trip can be challenging without the guidance of an expert, and there is a risk of accidentally ingesting poisonous fungi. Additionally, hallucinogens are not recommended for individuals with a family history of schizophrenia due to concerns about triggering psychotic episodes.
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Microdosing
Some people anecdotally report improved mood, energy, and cognitive function from microdosing psilocybin. However, there is limited scientific research specifically on the effects of microdosing. A 2020 systematic review by Ona G and Bouso JC, titled "Potential safety, benefits, and influence of the placebo effect in microdosing psychedelic drugs," is one of the few studies that specifically examines microdosing. While this review suggests that microdosing may have some benefits, more rigorous scientific research is needed to confirm these findings.
It is important to note that the effects of psilocybin are unpredictable and can vary widely depending on factors such as dosage, personality, mood, expectations, surroundings, health, and previous experience with similar substances. Additionally, adverse effects from psilocybin can occur even at low doses, including increased anxiety and depression, poor mood, low energy, insomnia, and physical discomfort. Therefore, it is generally not recommended to self-medicate with psilocybin, including through microdosing, without the guidance of a trained professional.
While microdosing psilocybin may be a topic of interest for some, it is essential to approach it with caution and to prioritize safety. If you are considering microdosing as a potential treatment option for depression or other mental health conditions, it is crucial to consult with a healthcare professional first and to ensure that you are following legal and safe practices.
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Clinical trials
In 2018, COMPASS Pathways received FDA Breakthrough Therapy designation for its investigation of psilocybin in treating treatment-resistant depression (TRD). The clinical trial enrolled over 400 patients who received synthesized psilocybin capsules, not mushrooms, over a period of 12 to 18 months. Preliminary studies have shown that psilocybin therapy can provide immediate and sustained reduction in depressive symptoms following a single treatment.
A 2017 study found that psilocybin decreased activity in the amygdala, a region of the brain associated with fear and anxiety. It also helped stabilize the default mode network, which is implicated in Alzheimer's, PTSD, and Autism Spectrum Disorder. This suggests that psilocybin could potentially calm negative emotions and enhance the therapeutic process. However, adverse effects such as dizziness, nausea, vomiting, paranoia, and frightening hallucinations highlight the importance of controlled administration.
Psilocybin has also been investigated in combination with psychotherapy for alcohol use disorder. A 2022 study found that participants who received psilocybin-assisted psychotherapy had fewer heavy drinking days over 32 weeks. While the short-term benefits are promising, the long-term durability of these effects beyond 32 weeks is unknown.
While psilocybin shows potential in clinical trials, it is important to note that it is a Schedule 1 drug under U.S. federal law due to its hallucinogenic properties and potential for abuse. Professional supervision and guidance are crucial when exploring psilocybin as a treatment option to ensure safety and monitor for any potential side effects.
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Frequently asked questions
The FDA has given psilocybin, the psychedelic compound in magic mushrooms, a "Breakthrough Therapy" designation for treating severe depression. This means that the FDA will expedite the development and review process for psilocybin-based treatments.
Psilocybin acts on the brain's serotonin system and has been shown to significantly and rapidly decrease depressive symptoms. It can also help stabilize the default mode network in the brain, which is involved in thinking about ourselves and others.
Yes, it is important to note that psilocybin is a hallucinogenic substance and can cause side effects such as dizziness, nausea, vomiting, paranoia, and hallucinations. It is crucial that it is taken in a controlled setting under professional supervision. Additionally, it is illegal to cultivate or possess psilocybin-producing mushrooms in the United States.
