By elocal magazine
A single dose of psilocybin coupled with “talk therapy” can significantly reduce depression in people with cancer for up to two years, according to a new study. While the study has limitations, its findings demonstrate the potential of psychedelic therapy in the context of cancer treatment.
Depression and a cancer diagnosis often go hand-in-hand, which can make an already difficult situation worse. Traditional antidepressants need to be taken regularly, can take weeks for their effects to kick in, and, for some people, they’re ineffective.
A new study led by Sunstone Therapies, a company focused on delivering psychedelic-assisted therapy in the medical setting, has examined the long-term effectiveness of a single dose of psilocybin on major depression in people with cancer.
“While the study was small and has limitations, this preliminary data is important in demonstrating the long-term and sustained impact of psychedelic therapy for cancer patients,” said Dr Manish Agrawal, the study’s lead and corresponding author and the CEO and co-founder of Sunstone Therapies. “We are committed to rigorous clinical research and excited for additional longitudinal studies in the field.”
Agrawal had led a previous trial that tested the effectiveness of using psilocybin to treat major depression in cancer patients. The present trial assessed the long-term effectiveness of a single dose of psilocybin combined with psychological support in adult patients with cancer and depression. Thirty participants with a mean age of 57.5 were recruited to the trial, each with curable or non-curable cancer and a diagnosis of major depression. None of the participants were taking antidepressant or antipsychotic medication and were not considered a suicide risk at the beginning of the trial.
All of the participants received a single 25-mg dose of psilocybin, after which they participated in two group and two individual psychotherapy sessions. Each participant had, before receiving the psilocybin dose, undergone two preparatory therapy sessions. Mental health was measured at two, 18, and 24 months using the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Hamilton Anxiety Rating Scale (HAM-A).
The MADRS includes questions about 10 symptoms, including apparent and reported sadness, inner tension, sleep, appetite, concentration difficulties, and pessimistic and suicidal thoughts. It yields an overall score from zero to 60, with higher scores indicating more severe depression. A score between seven and 19 indicates mild depression, between 20 and 34 indicates moderate depression, and 35 to 60, severe depression. The HAM-A analyzes anxiety severity by looking at 14 items, including tension, fears, insomnia, memory and concentration, sensory and physical symptoms. Summation of each of the 14 individual rated items yields a composite score between zero and 56, with a score of 17 or less indicating mild anxiety, 18 to 24 indicating mild-to-moderate anxiety, and 25 to 30 indicating moderate-to-severe anxiety.
Two patients died during the trial (not attributed to the treatment), leaving 28 available for the 24-month follow-up assessment. Of those that remained, at two months, 89.3% showed a significant reduction in depression, demonstrated by an average reduction in MADRS score of 20 points from baseline. At 24 months, 53.6% had a significant reduction in MADRS score (an average reduction from baseline of 15 points). Half (50%) of participants had both sustained reductions in depression and met the study’s criteria for remission at the two-year mark. Notably, 25% maintained mental health benefits to the two-year mark, without needing any further antidepressant medications or psychedelic treatments.
Regarding anxiety, at two months, 78.6% had a significant reduction in their HAM-A score (an average drop of 17 points from baseline), with 46.4% showing a significant reduction at 24 months (an average 14-point reduction from baseline). Overall, 17.9% experienced a significant reduction in anxiety at 24 months without needing additional psychedelic or antidepressant treatments.
“Notably, our findings suggest that a single 25-mg dose of psilocybin, combined with psychological support, can produce durable improvements in mental health,” Agrawal said. “These results suggest the potential of psychedelic-assisted therapy as a novel approach for people facing depression and anxiety in the context of cancer.”
There are obvious limitations to this study. Primarily, the small sample size and the absence of a placebo group. Additionally, the participants were highly selected; they were excluded for using antidepressants, antipsychotics, cannabis, or if they were a suicide risk. This means the study group was carefully filtered and may not accurately reflect the broader, more medically complex cancer patient population. There is a potential for bias, given that participants and researchers knew the treatment being given. And, importantly, while many patients benefited from the psychedelic treatment, the paper doesn’t deeply explore why some didn’t improve or relapsed.
Sunstone Therapies both led the study and provided the psychedelic-assisted therapy used in it. While this dual role might raise questions about potential bias, it’s not unusual in pharmaceutical and biotech research. For example, companies like Novo Nordisk conduct their own clinical trials for medications such as Ozempic. As with all such studies, independent, large-scale trials will be crucial to validate these early findings.
The researchers have recognized the need for larger, controlled trials to reproduce the findings seen here. So, despite its clear limitations, the study’s findings are encouraging and highlight the need for further rigorous investigation.
The study was published in the journal Cancer.
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