Psilocybin has been given Breakthrough Therapy Designation by the FDA for treatment-resistant depression (TRD), indicating that it has shown substantial improvement over available therapies for severe conditions.

In 2019, the FDA granted breakthrough therapy status to psilocybin for treating depression, recognizing its potential based on preliminary research. While this designation primarily focuses on depression, it reflects the growing interest in psilocybin’s therapeutic applications, which may extend to PTSD in future studies.

A study published in January 2025 in the American Journal of Psychiatry documents a trial conducted at Sheppard Pratt Hospital. Participants were in a major depressive episode This study suggested the efficacy and safety of psilocybin in severe TRD.

A 2022 paper authored by researchers from Harvard, Yale, and Columbia found that psilocybin use was associated with a 30% reduction in the rate of opioid use disorder.

In December 2024, the VA announced funding for its first study assessing the potential benefits of psychedelics, including psilocybin, for treating PTSD and alcohol use disorder in veterans. This initiative underscores the VA’s commitment to exploring innovative treatments for mental health conditions prevalent among veterans.

This 2024 study examined the effects of a Magnesium-Ibogaine treatment protocol (MISTIC), combined with other therapies, on 30 male Special Operations Forces veterans with traumatic brain injury (TBI). The study found significant improvements in functioning immediately and one month after treatment, as well as reductions in PTSD, depression, and anxiety at the one-month mark.

A 2022 study that found participants given psilocybin-assisted therapy reduced heavy drinking by 83%.

This 2024 article published in Cancer describes a phase 2, open-label trial that enrolled patients with curable and noncurable cancer and major depressive disorder.

Another population study found use of psychedelics like psilocybin predicted a 27% decrease in the odds of committing theft and a 22% decrease in the odds of arrest for a property crime.

The center has announced upcoming studies to determine the effectiveness of psilocybin as a new therapy for various conditions, including PTSD. This research aims to explore psilocybin’s potential in alleviating PTSD symptoms and contributing to mental health treatment advancements.

In this 2023 trial groups of patients with cancer who were diagnosed with major depression disorder were given treatment. A sustained response was observed in 24 (80%) patients, with 15 (50%) patients showing complete remission of depressive symptoms.

A trial published in 2025 in the American Journal of Psychiatry (Vol. 182) found that psilocybin-assisted therapy reduced neuroticism and increased extraversion, with decreased impulsiveness linked to reduced alcohol consumption.

Results from a 2023 trial published in the Journal of the American Medical Association revealed that a single dose of psilocybin, administered with psychosocial support, was associated with significant reductions in depressive symptoms

An open-label pilot study is underway to examine the safety and efficacy of two psilocybin administration sessions (15 mg and 25 mg), combined with psychotherapy, among U.S. military veterans with severe, treatment-resistant PTSD.

A study published in 2023 in Neuropsychopharmacology explored the safety and efficacy of psilocybin in participants with TRD (Treatment-Resistant Depression).Response and remission were evident in 42.1% of participants.

This 2021 article published in JAMA Psychiatry investigates the effect of psilocybin therapy in patients with MDD (Major Depressive Disorder). This clinical trial was conducted at the Center for Psychedelic and Consciousness Research at Johns Hopkins Bayview Medical Center in Baltimore, Maryland. Findings suggest that psilocybin with therapy is efficacious in treating MDD

A 2020 review in The International Journal of Neuropsychopharmacology examined the potential of psychedelics for treating PTSD. The authors highlighted MDMA, ketamine, psilocybin, LSD, and cannabinoids as promising options.

A 2022 Johns Hopkins study investigated the effects of psilocybin on patients with major depression. At the 12-month follow-up, 75% of participants demonstrated a significant positive response, and 58% achieved remission.

Population research finds that the use of psychedelics is strongly associated with reduced psychological distress and suicidal thinking.

This study explored how psychedelics helped reduce symptoms of racial trauma among Black, Indigenous, and people of color (BIPOC) in North America found that psilocybin, LSD, and MDMA led to significant reductions in traumatic stress and depressive symptoms following psychedelic use.

This 2023 study used a decision-analytic model to evaluate the cost-effectiveness of psilocybin-assisted therapy compared to traditional antidepressant treatments.

A meta-analysis involving several trials with psilocybin- assisted therapy found “large effect sizes for acute (80-240 min) and sustained (1 day, 1-8 weeks, and 3-4 months) decreases in suicidality” among people who received the treatment compared to the placebo group.

This 2020 study assessed the safety and feasibility of psilocybin-assisted group therapy for demoralization in older long-term AIDS survivor (OLTAS) men, a population with a high degree of demoralization and traumatic loss. Results demonstrated the feasibility, relative safety, and potential efficacy of psilocybin-assisted group therapy for demoralization in OLTAS.

This study investigates the safety and efficacy of psilocybin-assisted therapy in patients with treatment-resistant depression. The results suggest that psilocybin, when combined with psychotherapy, can lead to significant reductions in depressive symptoms,

The study investigates the effects of psilocybin as a potential treatment for anxiety and depression in patients with advanced-stage cancer. The research showed promising results,

A study involving a group of patients with cancer-related anxiety and depression randomly assigned to psilocybin treatment found that at the 6.5-month follow-up, 60–80% of patients showed clinically significant reductions in depression or anxiety.

In this double-blind trial from 2016 published in the Journal of Psychopharmacology, The effects of psilocybin were studied in 51 cancer patients with life-threatening diagnoses and symptoms of depression and/or anxiety.

This study, published in 2021 in Translational Psychiatry, tested 24 patients with major depressive disorder on the enduring effects of psilocybin therapy on cognitive flexibility, neural flexibility, and neurometabolic concentrations in brain regions implicated in acute psilocybin effects.

This study, published in 2016 found that 66% of heavy smokers in a study quit smoking after two to three doses of psilocybin with cognitive behavioral therapy.

This article discusses the potential therapeutic effects of psychedelics, specifically psilocybin, on mental health conditions like depression and anxiety.