South Africa: Ongoing Clinical Study On Psilocybin For Major Depressive Disorder And HIV-Positive Women

Psilocybin, the psychedelic said to have the least amount of unwanted side effects, is being used for preclinical and clinical tests for treating an immense variety of health-challenging conditions across every part of the world where it has found a legal reception. 

In this case, the bioceutical and medical cannabis company Cannsun Group PLC. received approval from the South African Health Products Regulatory Authority (SAHPRA) to commence a phase 2 study of psilocybin-assisted brief supportive psychotherapy in an HIV positive all-female group with major depressive disorder (MDD). All 30 of them will participate in the trial for three months, to be conducted in Cape Town. 

The head of Research & Development at Cannsun Group PLC., Donaghue Woodman, told Cannabis Science Tech in an interview that the study aims at assessing safety and efficacy of psilocybin in HIV-positive individuals as well as the contingent effect of estrogen and psilocybin in treating MDD among women.

As Woodman mentioned, Sub-Saharan Africa has an estimated 8.2 million people living with HIV, and MDD is one of its more prevalent comorbidities, specifically in women. Data presented by the South African College of Applied Psychology suggest that one in six South Africans suffers from anxiety, depression, or a substance use disorder: 40% of South Africans who live with HIV have a comorbid mental disorder, 41% of pregnant women are depressed, and about 60% of South Africans could be suffering from post-traumatic stress. 

Regarding HIV and the South African female population, according to Cannsun’s head of research, women are twice as likely to contract HIV than men. Specifically, women between ages 15–19 account for 6 in 7 new HIV infections and contribute to 63% of all new infections.

In 2020, an estimated 4200 women between the ages of 15–24 years became infected weekly, as reported by Cannabis Science Tech. 

On the other hand, women have previously been under-represented in clinical trials on mental health, and in those included, the published results were not always gender-specific. 

When asked about the relation between HIV and MDD, Woodman said that serious mental illness is associated with harder-to-treat progression of HIV infection. For instance, depression has been associated with lack of medication adherence among HIV-positive infected individuals. On the other hand, treatment with antidepressant medication has shown to assist in improving antiretroviral adherence among those suffering from mental health issues. 

Finally, Woodman stated, “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.”

Cannsun Medicinals contracted TASK, a multinational research institute that conducts clinical trials to determine the treatment effects of novelties in healthcare and offers services in conducting complex clinical trials in various therapeutic areas. The study will also benefit from the collaboration of Soraya Seedat, Professor of Psychiatry and executive head of the Department of Psychiatry at Stellenbosch University with 20 years of clinical, epidemiological and basic neuroscience research experience as a psychiatrist.

Results are set to be published in April (or May) 2023.

Photo Courtesy of National Cancer Institute on Unsplash.