Psilocybin-assisted therapy could help patients with cancer and major depression disorder, according to new data from an open-label Phase II trial published in JAMA Oncology.

Sunstone Therapies reported results from a 30-patient Phase II trial suggesting psilocybin and group therapy could lead to sustained reductions of depression symptoms in patients with cancer. The study’s authors noted that the trial lacked a placebo arm, but said the promising results justified a subsequent randomized control trial.

Rockville, Maryland-based Sunstone ran the study out of a community cancer center in Maryland. Patients received a 25mg dose of synthesized psilocybin alongside group and individual therapy, using a 1:1 patient to therapist ratio.

Psilocybin, which is the main psychoactive ingredient found in psychedelic ‘magic mushrooms,’ has been linked to improvement in several mental health conditions during early clinical research. Shifting clinical regulatory perspectives have led to a recent surge in clinical trials testing psychedelics, though most data is from early-stage clinical trials.

Positive Phase II data

In the Phase II study, psilocybin treatment led to a statistically significant, 19.1-point reduction in Montgomery-Asberg Depression Rating Scale (MADRS), measured eight weeks after treatment. MADRS is a ten-item questionnaire that psychiatrists use to measure symptoms of depression, leading to a final score between 0–60. Scores of 35–60 represent severe depression, 20–34 moderate depression, 7–19 mild depression, and 0–6 no depression.

The trial also led to a sustained response of symptom reduction in 80% of patients, with 15 of the 30 patients experiencing full remission.

No patients reported treatment-related serious adverse events, though the majority experienced mild adverse events. These included headache in 24 patients, nausea in 12 patients, and altered mood in eight patients.

Fourteen trial patients had curable cancers, and 16 patients had incurable cancers. Half of the enrolled patients reported previous treatment with an antidepressant drug therapy.