Information for Healthcare Professionals

The ALIGNED study is an investigator-initiated, randomised-controlled trial of pharmacogenomics-guided therapy versus standard care for people with moderate to severe depression.

Pharmacogenomics (PG) is the study of how genetic variations affect an individual’s likely response to therapeutic medications. Other potential biomarkers identified will be integrated with PG via machine learning to develop a predictive model of treatment response. PG-guided therapy has the potential to offer a more effective precision approach to treatment selection.
 
Study participants are randomised to either the pharmacogenomics-guided intervention arm or a standard care (control) arm. The prescribing doctors of all participants are provided with a treatment guide to inform prescription of antidepressant therapy. Prescribers in the intervention arm will receive a treatment guide informed by their patient’s pharmacogenomic analysis, whereas prescribers in the control arm will receive a treatment guide in line with best practice (not informed by their patient’s pharmacogenomics). 

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 major depressive disorder, baseline study assessments and randomisation will take place.

The study comprises 4 sessions (teleconference or phone call) with participants and will take approximately 3 months (12 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

Contact Central Coordinating Centre

Ethics Reference: 2021/ETH00806

The ALIGNED study is an investigator-initiated, randomised-controlled trial of pharmacogenomics-guided therapy versus standard care for people with moderate to severe depression.

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The ALIGNED Study

The George Institute for Global Health
Level 18, International Tower 3,                300 Barangaroo Ave,
Sydney  NSW 2000 Australia
[email protected]

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How to participate
Acknowledgement of Country

The George Institute acknowledges the Gadigal People of the Eora Nation as the Traditional Custodians of the land on which our Australia office and Global Headquarters are built. We pay our respect to Elders past, present and emerging.

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Personal Information Collection Notice

AustraLIan trial of GeNotype-guided pharmacothErapy for Depression (ALIGNED) Study

By completing the following questionnaire and any Expression of Interest form, you will be asked to provide personal information (including your name, contact details and health information) to The George Institute for Global Health (we, us, our).  

You have a choice whether you provide your personal information to us. If you choose not to provide your personal information you may still complete the questionnaire but you will not be contactable and therefore not be able to participate in the ALIGNED Study. 

If you choose to provide your personal information it will be collected and used by us for the purposes of registering your interest to take part in the ALIGNED Study and also to contact you directly to discuss your possible participation in the ALIGNED Study. 

If you do not participate in the ALIGNED Study, any personal information collected from you will not be included as part of the Study and will handled in accordance with our Privacy Policy and the law. 

If you participate in the ALIGNED Study you may be asked to provide additional personal information. As a participant, the information you provide at each stage of the ALIGNED Study will be collected and used by us for the purposes of medical research and analysis pursuant to the ALIGNED Study Participant Information Sheet you will receive. 

We may disclose your personal information that we collect to our staff, related parties, and approved third-parties (e.g. agents, service providers, collaborators and research partners) but only to such persons who need to know and only for the disclosed purpose. 

We are committed to protecting your privacy and ensuring your personal information is handled in accordance with applicable privacy laws. Our Privacy Policy (available at https://www.georgeinstitute.org/privacy-policy or here) sets out how you may access and seek correction of personal information that we hold, as well as the steps you can take should you wish to make a complaint about the handling of your personal information. Additional information can be found in our Data Sharing Policy (available at https://www.georgeinstitute.org/data-sharing-policy or here) and our Research Code of Conduct Policy (available at https://www.georgeinstitute.org/research-code-of-conduct-policy or here). 

Contact us:
The George Institute for Global Health 
Address: Level 5, 1 King Street, Newtown, NSW 2042 Australia; or
Email: [email protected]