Psychedelic therapy company Sunstone Therapies has announced the start of its first study investigating multiple doses of psilocybin in the treatment of major depression disorder (MDD) in patients with cancer.
The Phase 2 two-part study, taking place at the Bill Richards Center for Healing at the Aquilino Cancer Center, will examine the safety and efficacy of up to two 25mg doses of psilocybin in 56 patients administered at an interval of 9 to 10 weeks.
The first part of the study will administer a first dose of psilocybin in a double-blind, randomized, placebo-controlled portion, while the second part of the study will take the form of an open-label portion for patients who do not achieve MDD symptom remission after the first dose.
All study participants will be supported through the first dosing sessions by a study therapist in addition to a second therapist monitoring via video feed, and in the second session, all eligible participants will receive psilocybin 25 mg in an open-label fashion using a group session model.
Chief Medical Officer at Sunstone Therapies and Principal Investigator on the study, Paul Thambi MD, commented: “The emotional distress associated with cancer is often as significant as the physical effects, and yet oncologists have few effective treatments to tackle this important aspect of the patient experience.
“More recently, the use of psychedelic-assisted therapy has seen renewed interest and a number of studies show a positive impact on symptoms of depression in patients with cancer, including our own open label study published in JAMA Oncology.
“This new study includes a placebo control arm, the use of group administration, and – for the first time – multiple doses. We believe this adds significantly to the understanding of the role psilocybin-assisted therapy could play in improving patients’ lives and how it might best be delivered.”
Chief Executive Officer at Sunstone Therapies, and Clinical Investigator on the study, Manish Agrawal MD, added: “The Sunstone team has a longstanding commitment to advancing clinical research in psychedelic-assisted therapy in cancer patients, and unique depth of experience across psychedelic modalities and indications.
“This study builds on our pioneering approach to clinical trial design: there is limited data addressing the question of whether multiple administrations of treatment doses of psilocybin in patients with cancer lead to improved efficacy.
“We look forward to making a further contribution to the clinical development of this potentially vitally important treatment modality.”
The primary efficacy endpoint of the study is the change in the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to week 8, and secondary endpoints – which include the onset and durability of response, response rate and remission, and the effect on pain – will be used to assess parameters in both the placebo-controlled and open label study conditions.
