Bio-pharmaceutical company focusing on developing and commercializing new medicines to optimize human health Cannsun Group PLC announced having been granted regulatory approval by the South African Health Products Regulatory Authority (SAHPRA) to begin an in-human women focused clinical study to evaluate the safety and efficacy of psilocybin in 30 HIV positive study participants suffering from Major Depressive Disorder (MDD).
Cannsun which has operations in Thailand and South Africa says this trial will be a double-blind randomized, phase 2 feasibility study on psilocybin–assisted brief supportive psychotherapy in HIV positive women with MDD.
According to a global systematic analysis published in Lancet Psychiatry, MDD emerges as one of the most prevalent co-morbidities in HIV and in women. Previously, women have been underrepresented in clinical trials related to mental health and even in trials where women were included, the results were not gender specific, these are some of the major reasons why the trial is focusing on women only.
“It is vitally important to have a deeper understanding of how woman respond to medical treatment for major depression versus men in order to develop psychedelic therapies and treatment protocols for women that have clinically significant outcomes that are safe and effective. This research to be conducted in South Africa follows a globally renewed interest in psychedelics aimed at exploring the treatment benefits of these previously misunderstood compounds,” said the head of research and development in Cannsun, Donaghue Woodman.
Cannsum has hired TASK to conduct the clinical trial. TASK is a South Africa based multinational clinical research institute which conducts clinical trials to determine the treatment effects of novelties in healthcare. Additionally, TASK also offers services in conducting complex clinical trials in a wide range of therapeutics areas.
“The TASK team are proud to have been selected by the Cannsun group to conduct this ground-breaking trial, first in our unique African population. We look forward to making progress in the treatment of mental health disorders and to the influence this trial may have in generating further investment in psychiatric research with innovative compounds,” said the head of development business at TASK, Duncan McDonald.