The ALIGNED study is an investigator-initiated, randomised-controlled trial of pharmacogenomics-guided therapy versus standard care for people with moderate to severe depression.
The ALIGNED study is double-blind, with both prescribing doctors and participants blinded to treatment allocation.
At week 12 of the study, unblinding will take place, where both prescribing doctors and participants will be informed of treatment allocation. All prescribing doctors of 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.
Potential study participants will be screened using the DSM-5 MINI assessment to establish a diagnosis of major depressive disorder and the Montgomery-Åsberg Depression Rating Scale (MADRS) to determine depression severity. Following confirmation of moderate to severe major depressive disorder, baseline study assessments and randomisation will take place.
The study comprises 9 teleconference sessions with participants and will take approximately 24 weeks.
Register a patient for possible study participation
If you would like to register a patient for possible study participation, please contact the Central Coordinating Centre