LONG-acting, injectable antipsychotic drugs administered early show promise in treating schizophrenia – this is a preliminary finding of a long-term, multidisciplinary study conducted under the auspices of Stellenbosch University.
“These drugs have traditionally been used as the last option for chronic sufferers,” said Prof Robin Emsley, of the Department of Psychiatry, “but are now being considering as an early option and a useful intervention in resource-constrained settings.”
“Schizophrenia is a serious mental illness associated with changes in behaviour, thoughts and emotions, and seriously affects interpersonal relationships,” said Prof Soraya Seedat, Executive Head of the Department of Psychiatry. “Mental illnesses are the largest cost driver in health care globally. The World Economic Forum estimated that the cost of treating mental illness will reach $6 trillion annually by 2030 – more than other non-communicable diseases including diabetes, respiratory disorders and cancer.”
“However,” she continued, “for mental disorders there seems to be a persistent gap in research impacting on policy. This study is about a cost-effective strategy that can be reliably administered in a resource-constrained setting. It balances patients’ needs with innovation.”
“High-income country models are not appropriate in our setting,” said Emsley. “The treatment gap is larger than for other illnesses because of the direct costs of medication as well as indirect costs including unemployment and the care burden.”
Late diagnosis, non-adherence and substance abuse (often ‘tik’ in our setting) are major limitations in schizophrenia treatment. The illness is most aggressive in the early stages when the most damage is done. “There is major functional loss in the first five years,” said Dr Bonga Chiliza, the Programme Manager. “If you can intervene effectively in that period you can improve the long-term trajectory.”
The five-year study is funded by a NEPAD grant obtained through the Department of Science and Technology and the National Research Foundation. Additional support was obtained from the Medical Research Council, the Western Cape Provincial Government, the Project Ruth Trust, the Stanley Medical Research Institute and the Lundbeck International Foundation. Partnerships have been developed with the universities of KwaZulu-Natal, Potchefstroom, and Utrecht in the Netherlands, and Zucker Hillside Hospital in New York. Within Stellenbosch University the departments of Psychiatry, Psychology, Nutrition and Genetics are involved.
This is a clinical outcomes study examining environmental, pharmacological, neuro-imaging, genetics and psychosocial aspects. The study, conducted at Stikland Hospital in the Western Cape and at the University College Hospital, Ibadan, Nigeria, also aims to develop sustainable capacity for schizophrenia research (thus far eight PhDs and one MSC).
The study included 207 people aged 16 to 45 and looked at the use of flupenthixol decanoate usually given to chronically ill patients.
The most significant finding was a remission rate of 60%. “This is defined as low or no symptoms for six months which was a high bar and a very favourable outcome compared to other studies,” said Chiliza.
Patients were adherent with 92% completing 100% of the injections. Thirty three (19%) suffered relapse with eight (4%) requiring hospitalisation.
An injectable may improve adherence and also offers sustained release of the antipsychotic. “The use of an injectable makes adherence more transparent so it can be addressed timeously,” said Emsley.
Mindshift required
Emsley pointed out though that overcoming the historical image of these drugs will be challenging. “Traditionally there were concerns about the use of injectables – which were often given in high doses leaving patients sedated,” he said. “The issues are similar to those around Depo contraceptives – which were often administered in a paternalistic manner and not as the patient’s decision.”
With a young, mobile study population, an important component of the study’s success has been the assertive monitoring programme – including psychoeducation, shared decision making and home visits.
Emsley pointed out that this is a unique cohort, providing a wealth of data that will keep the researchers busy for years. “The study has discovered things that contribute to understanding illness and treatment,” he said. “This is not unique – but the main ingredients including effective intervention in the early stages of illness and addressing non adherence are key to optimal outcomes.”
“This offers a cost-effective psychosocial intervention,” he concluded. “This study has huge ramifications for clinical care in our setting and there is an urgent need to get it to the real-world clinical situation.”
Studies involving neuro-imaging to understand the changes that occur in the brain during schizophrenia; the development of sensitive, culturally appropriate cognitive function tests; increased understanding of the role of therapy; unlocking the genetic code as it relates to schizophrenia; and, long-term follow up of the study cohort are ongoing.
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