The George Institute for Global Health, St Vincent’s Hospital Sydney, and collaborating institutions across Australia are seeking participants for a new study looking at whether tailored antidepressant therapy based on individual patient’s genetic makeup can improve remission rates in depressed patients initiating antidepressants by mitigating trial-and-error iterations.
The ALIGNED study is an investigator-initiated, double-blind randomised-controlled trial of pharmacogenomics-guided therapy versus standard care for people with moderate to severe depression initiating pharmacotherapy.
For all patients enrolled in the study, you as a prescriber will be provided with a blinded and individualised treatment guide to inform initiation and prescription of antidepressant therapy for your patient. Prescribers for patients randomised to the intervention arm will receive a blinded treatment guide that had been informed by patient’s pharmacogenomic results, whereas prescribers in the control arm will receive a blinded treatment guide that had been developed in line with best practice (not informed by their patient’s pharmacogenomics). Each individualised treatment guide is prepared by practising psychiatrist and/or geneticist investigators with treatment recommendations that are in line with current RANZCP practice guideline.
At week 12 of the study, unblinding will take place, where both prescribersand participants will be informed of treatment allocation. All prescribersof participants will then receive a direct copy of the participant’s pharmacogenomic report issued by a NATA-accredited laboratory. The report contains pharmacogenomics information for psychotropic as well as other medications that can be used in the future.
The study comprises 11 teleconference sessions with participants and will take approximately 52 weeks.
If you have any questions or would like to register a patient for possible study participation, please contact the Central Coordinating Centre at ALIGNED@georgeinstitute.org.au
Find out more about the study at www.alignedstudy.org.au/