Australian Trial of Genotype-guided Pharmacotherapy for Depression (The ALIGNED study)

Australian Trial of Genotype-guided Pharmacotherapy for Depression (The ALIGNED study)

The ALIGNED study may help your patients with depression find the right antidepressant medication.

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 reducing trial-and-error iterations, and better managing side effects.

The ALIGNED study is an investigator-initiated, double-blind randomised-controlled trial of pharmacogenomics-guided therapy versus standard care for people with depression. The study is funded by the Medical Research Future Fund.

Participants randomised to the intervention arm (and their prescribing clinicians) will receive a treatment guide that had been informed by patient’s pharmacogenomic results, whereas participants in the control arm (and their prescribing clinicians) will receive a treatment guide that had been developed in line with best practice (not informed by participant’s pharmacogenomics).

For all participants enrolled in the study, you as the prescribing clinician will be provided with an individualised treatment guide containing antidepressant recommendations to inform initiation and prescription of antidepressant therapy for your patient. 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.

As the study is double-blinded, both you and your patient will remain blinded to which study arm your patient has been randomised to. At the end of 12 weeks of the study, unblinding will take place, whereby both study participants and their prescribers will be informed of treatment allocation.  At week 12, all prescribers and participants will receive a 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.

All study assessments are done remotely by a study coordinator. Participants will take part in 4 study sessions conducted via videoconference (i.e. Zoom) and over the phone. Participation in the study will take approximately 12 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 .  To find out more about the study at https://www.alignedstudy.org.au/ please email sue.kang@svha.org.au