Psilocybin for major depression granted Breakthrough Therapy by FDA (newatlas.com)

Article summary

The US Food and Drug Administration (FDA) has granted psilocybin therapy a Breakthrough Therapy designation for treating major depressive disorder (MDD). A non-profit research organization, the Usona Institute, is conducting a Phase 2 trial to explore the antidepressant properties of a single psilocybin dose in treating patients with MDD. The trial aims to enroll 80 subjects and is expected to be completed by early 2021. The FDA's Breakthrough Therapy designation is intended to accelerate the development and review of promising new treatments for serious or life-threatening conditions.

Main themes

• psilocybin therapy
• depression treatment
• psychedelics and mental health
• therapeutic use of psychedelics
• regulation and accessibility
• risks and benefits of psychedelics

What commenters say

• Psilocybin therapy has shown potential in reducing depression and anxiety in cancer patients, and its use should be considered in hospice care.
• The therapeutic effects of psychedelics are not just a placebo effect, but rather a result of altered perception and perspective.
• Some people believe that psychedelics should be used in combination with therapy to achieve optimal results, while others think that the use of therapists or guides is not necessary.
• There is a concern that the use of psychedelics could lead to negative consequences, such as weakening of important brain connections, but others argue that the benefits outweigh the risks.
• The use of psychedelics in a clinical setting requires a trained therapist or guide to support the individual, especially for those with prior trauma or mental health conditions.
• Some people think that the current black market for psychedelics is preferable to the potential commercialization of therapy, while others believe that legalization and regulation would improve safety and accessibility.