Results from an advanced clinical trial assessing psilocybin-assisted therapy for patients with cancer and Major Depressive Disorder (MDD) conducted by oncology center Sunstone Therapies were published in the acclaimed JAMA Oncology.
The open-label Phase 2 study tested psilocybin paired with psychological support in 30 patients with curable and incurable cancer. Participants were divided into cohorts of 3 to 4 and each was given a 25 mg single dose of COMPASS
CMPS-0.10%+ Free Alerts’ synthetic psilocybin COMP360.
Dosing was done simultaneously on all patients, who were located in adjacent rooms open to a common space, in a one-on-one therapist/patient ratio. Group therapy was provided throughout one preparation and two integration sessions, which were supplemented by individual therapy.
Data from the study showed a sustained response in 80% of patients and 50% of patients in full remission of depressive symptoms, as measured on MADRS scores, from baseline to 8 weeks post-treatment.
Self-reported measures of depressive symptoms supported the findings, with an average 48% reduction from baseline and a 53% decrease in depression severity.
Sunstone’s CEO and the study’s PI, Dr. Manish Agrawal said the trial is “the first of its kind,” conducted within a community hospital cancer center in groups and using a lower therapist-to-patient ratio than previous psilocybin therapy studies.
“This approach has been shown to be effective in delivering a significant improvement in these patients’ depression symptoms and, if replicated in larger studies, could open the door to a wider and faster adoption of psilocybin therapy in the future,” Dr. Agrawal said.
Chief therapist Bill Richards, Ph.D. commented that although the number of study participants was small, the results from the open-label study add to the growing body of evidence on psilocybin therapy for mental distress and provides hope to cancer patients and their families of an effective treatment for depression associated with their condition which, he says, “impacts 1 in 4 people with cancer and often becomes a debilitating aspect of their diagnosis.” (Full Story)