Do psilocybin, MDMA, LSD, ketamine, and cannabis sound familiar as medication therapy to help treat mental illness? It goes without saying that the pandemic has intensified mental health symptoms in the United States (US), turning an urgent matter into a crisis. One in 5 American adults suffers from mental illness, with young adults ages 18 to 25 years reporting the highest prevalence. These numbers speak volumes. Some treatment options do not adequately treat patients with mental illness and are associated with significant side effects. This underscores the need for more effective treatments. Because of these factors, psychedelics and other psychoactive substances are gaining momentum as possible alternatives.

Psychedelics are a “mind-manifesting” hallucinogenic class of psychoactive compounds that affect perception. They have been used by ancient civilizations for medicinal purposes and religious rituals for thousands of years. There is a renewed interest in using psychedelics to treat mental disorders driven by global research, influencers, education, and patient voices. Philanthropy has been the main funding source for psychedelics. However, a recent federal grant to Johns Hopkins Medicine to study psilocybin for tobacco addiction may signal a sea change in federal funding of psychedelic research.

While small-scale clinical trials have been promising, for psychedelics to become mainstream, large-scale randomized controlled trials are needed to fully evaluate their safety and efficacy. Studies are underway through several leading centers including MAPS – the Multidisciplinary Association for Psychedelic Studies – a non-profit dedicated to psychedelic research.

Psychedelics are not currently approved as prescription medications. Notably, the US Food and Drug Administration (FDA) has given Breakthrough Therapy designation to two psychedelics – MDMA-assisted psychotherapy for post-traumatic stress disorder (PTSD) and psilocybin-assisted therapy for treatment-resistant depression (TRD) and major depressive disorder (MDD). FDA’s Breakthrough Therapy is designed to “expedite the development and review of drugs which may demonstrate substantial improvement over available therapy.” As clinical trials progress, 2023 could bring regulatory approval for the MAPS’ MDMA-assisted psychotherapy for PTSD, a potential turning point in the mental health treatment paradigm.

Patients with mental health illnesses deserve to heal and restore balance to their lives without stigma and judgment and deserve treatments that are safe and efficacious. Step into Magellan’s Clinical Insights for the role of psychedelics in treating mental health conditions. This industry-first paper explores the current evidence, regulatory, and legislative landscape for psychedelics and shares Magellan’s four pillars on emerging therapeutic frontiers. We are guided by four principles:

  • Education and thought leadership for patients, payers, providers, and stakeholders while addressing the stigma around mental health
  • Evidence-based clinical recommendations and coverage
  • Patient safety by advocating for quality standards
  • Access that is responsible and sustainable

Disclaimer: The content in this blog article is not a substitute for professional medical advice. For questions regarding any medical condition or if you need medical advice, please contact your healthcare provider.