First clinical trial launched to test psilocybin therapy for depression in cancer patients

The first clinical trial to test the safety and feasibility of psilocybin therapy with simultaneous administration and one-on-one patient support to treat depression in cancer patients was launched today by Maryland Oncology Hematology at the Aquilino Cancer Center at Adventist HealthCare Shady Grove Medical Center. A lead therapist will oversee groups of two to four patients receiving a synthetic form of psilocybin, with constant one-on-one attention from trained therapists.

Traditional approaches to treat major depression don't work in all cancer patients. This trial could transform the way we help cancer patients cope with the psychological impact of life-threatening disease. We will investigate the combination of individualized treatment along with group administration for creating a network of support and shared experience that could provide long-term relief from symptoms of depression."

Manish Agrawal, MD, the principal investigator for Maryland Oncology Hematology at the Aquilino Cancer Center at Adventist HealthCare Shady Grove Medical Center

More than 2 million people in the U.S. are treated each year for cancer and up to one in four suffer from major depression, yet many traditional approaches to mental healthcare are not effective for these patients.

Physicians with Maryland Oncology Hematology, the largest independent cancer physician practice in Maryland, will enroll 30 patients into the new study, over six months. Each patient will receive a single 25mg dose of synthesized psilocybin, combined with psychological support from specially trained therapists. Psilocybin will be given to between two to four patients simultaneously, with each patient supported one-to-one throughout their six to eight-hour experience. Participants will meet with their assigned therapist to establish a therapeutic relationship prior to receiving psilocybin. Patients will be followed for at least eight weeks to measure changes in depression symptoms.

Doctors have become increasingly eager to address quality of life in addition to longevity for cancer patients. In response to this trend, treatments will be administered in a new 2,700-square-foot center at the Aquilino Cancer Center specifically designed for the administration of psilocybin therapy. The space will also host group and individual therapy, acupuncture, exercise and self-care classes, and other holistic approaches to address the emotional and psychological needs of cancer patients, their families and the community.

"In cancer care, there is a myopic and intense focus on treating the disease, but a cancer diagnosis has far-reaching impact on a person's life, including their emotional and spiritual health," said Paul Thambi, MD, an investigator on the trial and a medical oncologist with Maryland Oncology Hematology. "We need better tools to support all of our patients' needs, and specifically cope with the psychological impact of their disease."

The study will use COMPASS Pathway's investigational COMP360 psilocybin therapy, in which COMP360, a synthesized psilocybin formulation, is administered in conjunction with psychological support from therapists trained in the COMPASS protocol. COMPASS Pathways, a mental health care company, has provided support, training, and funding for the study.

To participate, patients over the age of 18 must have a malignant cancer and a diagnosis of major depressive disorder without current use of antidepressant, antipsychotic medications or medical cannabis at screening. Those with a history of certain psychiatric conditions will not be able to participate because of the known risks of psilocybin therapy in these patients.

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