What does psilocybin do for cancer patients and people with major depression?

New research published in JAMA Oncology suggests that psilocybin therapy may help relieve symptoms of major depressive disorder in cancer patients. It has been reported that approximately 15% of cancer patients experience major depression, which is associated with decreased adherence to therapy and poorer quality of life. Despite the high prevalence of major depression in cancer patients, many oncologists feel inadequately prepared to deal with mental health issues. Current treatment options have also shown limited effectiveness in treating depression.

Psilocybin, a 5-HT2A receptor agonist, may offer a new alternative treatment for depression. Previous studies have demonstrated the effectiveness of psilocybin in reducing various psychiatric symptoms when administered at a ratio of 2 therapists per patient. The current study aimed to establish a scalable and quickly adequate treatment for depression with psilocybin with a therapist to patient ratio of 1 to 1.

The researchers also emphasized that, to their knowledge, this is the first study of psilocybin therapy to be conducted in a community cancer setting rather than in an academic institution or psychiatric hospital.

The study

Lead researcher Manish Agrawal, MD, who is part of the Center for Psychedelic Therapy and Research, co-founder and CEO of Sunstone Therapies, and co-director of clinical research at the Aquilino Cancer Center, stated in an interview with Pharmacy Times® that his studies were in characteristic in two ways.

First, it used a group approach that differed from previous studies of psychedelics-assisted therapy in cancer patients conducted in specialized academic hospitals or large mental health facilities. In addition, the study was conducted in a community cancer center, which provided a new environment for such research.

For the Phase 2 study, which was open-label and fixed-dose, 30 participants were admitted to the Aquilino Cancer Center or referred from specialized oncology and mental health services. Patients were divided into groups of 3 to 4 based on time of enrollment, and all were adults diagnosed with cancer and major depressive disorder.

The mean age of the participants was 56 years, the group consisted of 70% women and 30% men. Of the 30 people, 14 (47%) had cancer that was considered curable, while 16 (53%) had an incurable cancer. Half of the participants also said they had previously been treated with antidepressants.

Administration, preparation and integration

In this study, each cohort of participants received a 25 mg dose of COMP360 in separate rooms connected to a common room, and the therapist to patient ratio was 1:1. The groups received group therapy consisting of a preparation session, two integration sessions and individual therapy. Outcomes of interest included safety and improvement in depression, assessed primarily using the Montgomery-Asberg Depression Rating Scale (MADRS), with higher scores indicating more severe depression.

According to Agrawal, the patients went through a group prep session before receiving psilocybin, which was administered concurrently in adjacent rooms. This process was referred to as co-administration. The day after the psilocybin session, the patients came back to discuss their experiences.

This was followed a week later by another session where they discussed their experiences further, called integration. As Agrawal explained, this approach of co-administration, group preparation and group integration has not previously been explored in patients with cancer or any other population.

Remission was defined as a MADRS score of less than 10 after treatment, and prolonged response to therapy was defined as a reduction in MADRS score of at least 50% from baseline by weeks 3 and 8. The Maudsley Visual Analogue Scale and the Quick Inventory of Depressive Symptomatology-Self-Report were two other tests for depression.

According to the Columbia Suicide Severity Rating Scale, no serious adverse events (AEs) were associated with treatment during the research, nor was there any suicidality. Hallucinations (n=1), anxiety (n=7), mood swings (n=8), nausea (n=12), and headache (n=24) were minor or expected adverse events.

Results of the experiment

The significant decrease in MADRS scores from baseline to post-treatment indicated the effectiveness of psilocybin treatment. The results showed a reduction of 19.1 points by week 8, with 80% of patients showing a sustained response. Notably, 15 (50%) patients achieved complete remission of their depressive symptoms.

Self-reported measurements of depressive symptoms enhanced the reduction in MADRS scores. The Quick Inventory of Depressive Symptomatology – Self-Report showed a mean decrease of 5.9 points, a 48% decrease from baseline through week 8. Similarly, the Maudsley Visual Analogue Scale showed a 53% decrease in self-rated depression severity , which means a decrease of 46.2 points.

Researchers concluded that participants showed a clinically significant improvement in depression symptoms that lasted rapidly and for 8 weeks after a single psilocybin therapy treatment. This improvement was seen in patients with both curable and incurable cancers.

The lack of a control group was one of the limitations noted by the researchers. The researchers concluded that their findings support a randomized clinical trial, but more studies are needed to evaluate placebo and various antidepressant drugs for cancer patients.

Agrawal noted that the study, with just 30 patients, had some limitations, such as the lack of a placebo group. Still, the effectiveness was significant and intriguing. But the most exciting thing was that the people in the group felt really connected and wanted to share their experiences and stories for mutual benefit. Because of the benefits they observed in the studies, [which] showed quite spectacular results, individuals still meet once a month. This is two years after the studies ended, and participants were only followed up for 8 weeks.

Diploma

The landmark study of psilocybin therapy in cancer patients has enabled new ways to treat depression in a community cancer setting. In patients with both curable and incurable malignancies, study results showed a significant reduction in depressive symptoms, including sustained response and complete remission. According to the unique methodology of concurrent delivery, group preparation and group integration, no significant side effects were detected.

Despite the limitations of the study, the results provide a solid foundation for future research. It’s impossible to deny the potential benefits of psilocybin therapy for cancer patients, and researchers have recommended that more randomized clinical trials be conducted in the future.

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