Cannsun Group PLC (“Cannsun“), a biopharmaceutical company focused on developing and commercializing new medicines to optimize human potential with operations in South Africa & Thailand, announces the receipt of approval from the South African Health Products Regulatory Authority (SAHPRA) to commence a women’s specific clinical trial to evaluate safety and efficacy of psilocybin in 30 HIV positive study participants suffering from Major Depressive Disorder.
The trial is a Double-Blind, Randomized, Phase 2 Feasibility Study of Psilocybin-Assisted Brief Supportive Psychotherapy in HIV Positive Females with Major Depressive Disorder.
Mental health disorders are one of the leading causes of disease burden in the world, according to a 30-year global systematic analysis published in Lancet Psychiatry. As MDD is one of the more prevalent comorbidities in HIV and in women, where an estimated 7.7 million people are living with HIV in South Africa, the trial will be conducted in an all-female HIV-positive group.
“It is vitally important to have a deeper understanding of how women 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.” – Donaghue Woodman, Head of Research & Development at Cannsun Group PLC.
Cannsun Medicinals has contracted TASK, a multinational clinical research institute that conducts clinical trials to determine the treatment effects of novelties in healthcare and offers services in conducting complex clinical trials in a wide variety of therapeutic areas.
“The TASK team is proud to have been selected by the Cannsun group to conduct this ground-breaking trial, the 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.” – Duncan McDonald, Head of Business Development at TASK.
TASK will work in conjunction with Soraya Seedat, a distinguished Professor of Psychiatry and Executive Head of the Department of Psychiatry at Stellenbosch University. She has more than 20 years of clinical, epidemiological and basic neuroscience research experience as a psychiatrist.
She has also been the recipient of several awards, including the World Federation of the Society of Biological Psychiatry Fellowship, the Lundbeck Institute Fellowship Award in Psychiatry, an MRC mid-career award, research fellowship from the University of California San Diego, the Anxiety Disorders Association of America Career Development Award, the Humboldt Research Award in memory of Neville Alexander, the Chancellor’s Award for Research from Stellenbosch University and an MRC Gold Merit Award.
“Mental health is a global pursuit, and we are hopeful this research may bring advancement of treatment of depression and anxiety illness. Our R&D team at Cannsun aims to further advance medical treatments in South Africa utilizing emerging medicines.” – David Parry, Chief Executive Officer at Cannsun Group PLC.
All clinical trials conducted by TASK are reviewed and approved by the South African Health Products Regulatory Authority (SAHPRA) and an independent ethics committee prior to trial commencement and follow Good Clinical Practice (GCP) standards and guidelines. Study participation is in line with GCP and is completely voluntary.
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