Psilocybin-assisted psychedelic therapy reduces depressive symptoms in adults with cancer and depression

Results from a phase II clinical trial indicate that psilocybin, a hallucinogenic chemical found in certain mushrooms of the Psilocybe genus, may benefit people with cancer and major depression. Trial participants treated with psilocybin not only saw a decrease in depressive symptoms, but also praised the therapy when surveyed at the end of the trial.

The results are published in two articles published online in Cancer.

By binding to a specific subtype of serotonin receptor in the brain, psilocybin can cause alterations in mood, cognition, and perception. Psilocybin is currently classified as a Schedule I drug – defined as having no accepted medical use and a high potential for abuse – and is not approved by the United States Food and Drug Administration for clinical use. .

However, several randomized controlled trials have demonstrated the safety and potential effectiveness of psilocybin-assisted therapy, which combines psilocybin with psychological support from trained therapists, to treat major depressive disorder. Additionally, there is ongoing research investigating the use of psilocybin-assisted therapy to treat a variety of other mental health conditions, such as anxiety, addiction, and post-traumatic stress disorder.

In this latest open-label Phase II trial involving adults with cancer and major depression, 30 participants from Sunstone Therapies in Rockville, Maryland, received a single dose of 25 mg of synthesized psilocybin plus a 1:1 session with a therapist and group therapeutic support.

“This study was differentiated by its group approach. Cohorts of three to four patients were treated simultaneously with 25 mg of psilocybin in adjacent rooms open at the same time, in a 1:1 therapist-to-patient ratio. cohorts were prepared for therapy as well as integration sessions after the group psilocybin session,” explained lead author Manish Agrawal, MD, of Sunstone Therapies.

Enrolled participants had moderate to severe depression scores at baseline. After eight weeks of treatment, Dr. Agrawal and his colleagues observed that patients’ depression severity scores had dropped by an average of 19.1 points, a magnitude that would indicate that the majority no longer suffered from depression.

Additionally, 80% of participants experienced a lasting response to treatment and 50% experienced complete remission of depressive symptoms after one week, which lasted for eight weeks. Treatment-related side effects, such as nausea and headache, were generally mild.

“As an oncologist for many years, I have felt the frustration of not being able to provide cancer care that treats the whole person, not just the tumor,” Dr. Agrawal said. “This was a small, open-label study and more research needs to be done, but the potential is great and could have implications for helping millions of cancer patients who also struggle with the serious psychological consequences of cancer. disease.”

Dr. Agrawal is also the lead author of a second study led by Yvan Beaussant, MD, MSc, of the Dana-Farber Cancer Institute, which collected feedback from patients participating in the trial during exit interviews. Participants described generally positive experiences. In terms of safety, they noted that being part of the group calmed their fears and increased their sense of preparedness to engage in therapy.

Regarding therapeutic effectiveness, they felt that being connected to the group deepened and enriched their experience, ultimately contributing to their experience of self-transcendence and compassion for one another. Additionally, the use of individual and group sessions was found to support therapy in different ways. For example, the implementation of individual and group sessions allowed therapy to remain an intimate, introspective process while adding a feeling of “friendliness”.

“As a hematologist, physician and palliative care researcher, it was deeply moving and encouraging to see the extent of participants’ improvement and the depth of their healing journey after participating in the trial. Participants overwhelmingly expressed positive feelings about their psilocybin experience. assisted therapy while emphasizing the importance of the supportive and structured setting in which it took place,” said Dr. Beaussant.

“Many described a continued transformative impact on their lives and well-being more than two months after receiving psilocybin, feeling better equipped to face cancer and, for some, the end of life.”

Before this intervention is implemented in clinical practice, additional studies should include a larger number of patients, as well as a control group to compare its effects with other treatments or a placebo.