Psilocybin-assisted group therapy shows promise in reducing depression symptoms in cancer patients, according to new research published in the journal CANCER, a peer-reviewed publication of the American Cancer Society.
Psilocybin, a naturally occurring psychedelic compound, is known for its ability to alter mood, cognition, and perception by targeting serotonin receptors in the brain. Despite its classification as a Schedule I drug, indicating a high potential for abuse and no accepted medical use, recent studies have spotlighted its therapeutic potential. In psilocybin-assisted therapy, patients undergo a structured treatment involving psilocybin administration under the guidance of trained therapists, blending the drug’s effects with psychological support.
Cancer often brings with it the shadow of major depressive disorder, affecting up to 20% of cancer patients in the United States. This condition not only diminishes the quality of life but also complicates treatment adherence and overall healthcare costs. Unfortunately, existing depression treatments for these patients are often inadequate. This study was motivated by the urgent need to find more effective therapeutic options for this vulnerable group.
“I worked as an oncologist for over 20 years and as time went on saw first-hand how the impact of cancer extended far beyond the physical manifestation of the disease,” said study author Manish Agrawal, the chief executive officer and co-founder of Sunstone Therapies. “For too long we’ve focused on treating the tumor, with little regard for the immense mental and emotional distress that frequently accompanies a diagnosis and I often saw that even when a patient made a full recovery, their mental health continued to suffer.”
“Ultimately it was this that led me to devote the next phase of my career to developing a new model for treating depression in cancer patients. I became interested in psychedelic-assisted therapy (PAT) and the promise it held for those struggling with mental health disorders. At Sunstone Therapies, we have now completed more than 100 PAT treatments in indications ranging from depression in cancer to PTSD.”
The recent phase II open-label trial, conducted at Sunstone Therapies in Rockville, Maryland, explored the feasibility of psilocybin-assisted therapy in a novel group setting. The trial included 30 adults with cancer and major depression, each receiving a 25 mg dose of synthesized psilocybin. The therapy involved both individual and group sessions, with 3-4 patients treated simultaneously in adjacent rooms. The therapists provided support individually and during group integration sessions.
The trial’s results were promising: patients’ depression severity scores significantly decreased, with an average drop of 19.1 points over eight weeks. Impressively, 80% of participants showed a sustained response to the treatment, and 50% achieved full remission of depressive symptoms. Side effects, such as nausea and headaches, were generally mild.
“Psilocybin-assisted therapy has enormous potential for the treatment of major depressive disorder in patients with cancer,” Agrawal told PsyPost. “The results were highly positive: psilocybin-assisted therapy was shown to induce a clinically meaningful reduction in depression severity (MADRS) scores by 19.1 points (95% CI 22.3 to -16.0, p<0.0001) from baseline to post-treatment of Week 8 following administration. 80% of participants demonstrated a sustained response to psilocybin treatment; 50% showed full remission of depressive symptoms at Week 1 which was sustained for eight weeks.”
“This study is a small, open-label study and more work needs to be done, but the safety and efficacy outcomes strongly support further research. The group therapy approach is new, and the positive results suggest a pathway towards wider and faster adoption in the future.”
Qualitative interviews with 28 participating patients further illuminated the therapy’s impact. A few participants felt that the number of therapists and researchers in group sessions could be overwhelming, suggesting a more streamlined approach might be beneficial. But many participants expressed a heightened sense of safety and preparedness due to the group setting, finding comfort and reassurance in shared experiences.
As one participant described: “I think it was definitely better to do it in a group. It makes it less scary… you’re not alone.”
The group therapy was seen as enhancing feelings of connection, belonging, and compassion, potentially contributing to the therapeutic effect. Participants felt they were part of a supportive group, which was particularly significant given the often isolating nature of both cancer and depression.
“This is the first time we’ve explored psilocybin-assisted therapy for the treatment of major depressive disorder in patients with cancer in a group setting and I was surprised by how much people reported that they enjoyed and benefited from the group aspect of the study,” Agrawal said. “A huge number of participants reported the group provided a greater sense of connection and belonging which enriched and deepened the meaning of their experience far beyond what we anticipated. They really bonded over the shared experience and still meet frequently.”
The new findings corroborate the results of a smaller study, which provided initial evidence of the safety, feasibility, and possible efficacy of psilocybin-assisted group therapy for cancer patients dealing with depressive symptoms.
This research suggests that psilocybin-assisted therapy could be a game-changer for cancer patients suffering from major depressive disorder. It potentially offers a new pathway for treatment, one that combines the powerful effects of psilocybin with the benefits of group therapy, potentially transforming the way depression is treated in this demographic.
“As a hematologist and palliative care physician and researcher, it was profoundly moving and encouraging to witness the magnitude of participants’ improvement and the depth of their healing journey following their participation in the trial,” said study author Yvan Beaussant of the Dana-Farber Cancer Institute.
“Participants overwhelmingly expressed positive sentiments about their experience of psilocybin-assisted therapy while emphasizing the importance of the supportive, structured setting in which it took place. Many described an ongoing transformative impact on their lives and well-being more than two months after having received psilocybin, feeling better equipped to cope with cancer and, for some, end of life.”
Despite these promising results, the study has limitations. Its small sample size and lack of a control group call for cautious interpretation. The absence of a control group (such as a placebo or alternative treatment group) means that it’s difficult to conclusively attribute the observed benefits solely to psilocybin therapy. Without a comparative baseline, it’s challenging to measure the true efficacy and impact of the treatment. Additionally, the study’s open-label design can introduce bias, as participants knew they were receiving psilocybin, potentially influencing their expectations and experiences.
“This was a pioneering but early stage, small, open label study,” Agrawal told PsyPost. “The results are exciting, but more work needs to be done to provide further insight into the potential this type of therapy holds for the treatment of major depressive disorder in patients with cancer.”
“Studies including this one show the potential of psychedelic-assisted therapy in treating patients suffering with mental health disorders. If we get this right, a lot of patients could benefit from these medicines. But we have to get this right – with approved, widely-accessible therapies delivered in gold-standard clinics.”
“Delivery of psychedelic-assisted therapy is complex and requires significant capabilities and experience, from clinical care to infrastructure, training and operations,” Agrawal continued. “Outside of clinical studies, we must continue to prepare for delivery in the real world once these psychedelic medicines have been approved. At Sunstone, we are drawing on our deep experience in cancer care to establish the gold standard for delivery to ensure safety, and to provide better, more whole person care. This will be critical to achieving long-term acceptance of these new therapies.”
The study, “Psilocybin-assisted Group Therapy in Patients with Cancer Diagnosed with a Major Depressive Disorder“, was authored by Manish Agrawal, William Richards, Yvan Beaussant, Sarah Shnayder, Rezvan Ameli, Kimberly Roddy, Norma Stevens, Brian Richards, Nick Schor, Heather Honstein, Betsy Jenkins, Mark Bates, and Paul Thambi.
The study, “Acceptability of Psilocybin-assisted Group Therapy in Patients with Cancer and Major Depressive Disorder: Qualitative Analysis“, was authored by Yvan Beaussant, Elise Tarbi, Kabir Nigam, Skye Miner, Zachary Sager, Justin J Sanders, Michael Ljuslin, Benjamin Guérin, Paul Thambi, James A. Tulsky, and Manish Agrawal.
