The protocol of an Australian-first pilot study based at the Perron Institute in Western Australia which explores the efficacy of personalised antidepressants in young people with major depressive disorder (MDD) has been published.
As well as measuring the effectiveness of a tailored approach for participants aged 16 to 24, the GENE-YD Study will inform the feasibility of a much larger randomised controlled trial in Australia.
The novel approach is published in the BMJ Open journal article PharmacoGENEtics in Youth Depression (GENE-YD) Study protocol: a pilot triple-blinded randomised controlled trial using pharmacogenetics to tailor antidepressant treatment in young Australians.
The prevalence of depression is on the rise and with it, the prescription and consumption rates of antidepressants but for over one third of young people with MDD, traditional antidepressant pharmacotherapy has little to no beneficial effect.
“Antidepressant medication failure due to persisting side effects or a lack of treatment response, is often coupled with a replacement prescription of another antidepressant drug,” said first author, Brad Roberts, a PhD candidate at the Perron Institute and The University of Western Australia.
“Research shows this not only increases a patient’s likelihood of developing medication-related side effects but also reduces the likelihood of symptom remission.
“Deeply concerning also, is that these children and youth are at increased risk of self-harming behaviours and suicidal thoughts.
“There is a need to move away from the clinical trial-and-error antidepressant prescription process, particularly for young people with MDD.
“Genetic variations can influence how individuals metabolise antidepressants, that’s why pharmacogenetic (PGx) testing may be useful in guiding clinicians when selecting medication for their young patients to improve response and tolerability.
“To date, the majority of PGx research has focused on adults, with limited studies examining the clinical effects of PGx-guided antidepressant prescription in youth.”
The pilot study is the first triple-blinded randomised controlled trial protocol for PGx research in Australian youth. This means the participants, their treatment team, and investigators do not know who is receiving guided treatment based on their PGx analysis and who has been assigned to the control group receiving treatment based on current best practice guidelines.
Youth Mental Health Research Coordinator and second author Zahra Cooper (Perron Institute and UWA) said, “The protocol design was informed by the results of previous focus groups with the target demographic, published by the study team in Frontiers in Pharmacology earlier this year.”
“The study team hope to further expand the feasibility of this work to regional and rural areas to ensure more younger people are represented.”
Senior authors of the paper are Professor Jennifer Rodger (head of Brain Plasticity Research at Perron Institute and UWA), psychiatrist Professor Sean Hood (head of Psychiatry at UWA), and genetics researcher Professor Anthony Akkari (Perron Institute, Murdoch University, UWA and Duke University), and other authors are postdoctoral researcher Dr Aleksandra Miljevic (Perron Institute and UWA), Associate Professor Susanne Stanley (UWA), Dr Bernadette Majda (Curtin University), Dr Khan Collins (North Metropolitan Health Service, WA Department of Health), and Drs Svetlana Baltic and Suzannah Lindsey-Temple from WA biotechnology company, Gene S, who provided the PGx test kits.
The study was funded by the Sarich family and the PGx test kits were funded by the Future Health and Innovation Fund’s Innovation Challenge.
Photo caption: Brad Roberts and Zahra Cooper at the Perron Institute