The ALIGNED Study is looking at how pharmacogenomics can help to find the right antidepressant medication for people with depression.

Pharmacogenomics is a new, simple genetic test which can determine the way a person’s body will respond to medication.

Ethics Reference: 2021/ETH00806

AustraLIan trial of GeNotype-guided pharmacothErapy for Depression

About the Study

Depression is a common form of mental distress that affects 1 in 7 Australians in their lifetime.¹Depression can affect people in many different ways, including poor sleep, appetite changes, reduced energy, concentration and productivity, lower self-esteem; and it can also lead to other health issues. Sometimes, they might think of harming themselves. Often, they find it hard to enjoy life or be productive.²

Recovery from depression is possible with treatment options including psychotherapy (talking therapy), cognitive behavioural therapy and medication. In fact, almost 10% of Australians use antidepressants each year.³Finding the right medication and the right dose can be challenging, often requiring several trial-and-error attempts. Approximately two thirds of people do not get better with the first medication they’re prescribed and one third of people do not recover even after four different medications are tried.⁴

Pharmacogenomics is a new, simple genetic test which can determine how a person will respond to medication. The ALIGNED Study (AustraLIan trial of GeNotype-guided pharmacothErapy for Depression) is looking at how pharmacogenomics can help to find the right antidepressant medication for people with depression, in order to reduce adverse effects and increase medication tolerability, improving the likelihood of recovery from depression.

References:

www.beyondblue.org.au/media/statistics
Schofield D, et al. BJPsych Open. 2019;5:e40. doi: https://doi.org/10.1192/bjo.2019.26
Australian Bureau of Statistics. Patterns of Use of Mental Health Services and Prescription Medications 2016. Available from: https://bit.ly/3wVN8hZ
Rush AJ, et al. Am J Psychiatry. 2006;163:1905. doi: https://doi.org/10.1176/ajp.2006.163.11.1905

Information for Participants

To be eligible to take part in the study, you will:

Be aged 18 to 80
Live in Australia
Have depression
Not currently taking antidepressant medication (although you can have taken it in the past) or thinking to change your current antidepressants
Be willing to consider antidepressant medication treatment

The ALIGNED Study will be conducted in cooperation with your GP (or other treating doctor). The study will test if prescription of medication guided by pharmacogenomics and possibly a brain scan is better than the choice that your doctor would make, informed by the best available guidelines.

There are 4 study sessions over a period of approximately 3 months (12 weeks). All sessions will be done by videoconference e.g., ZOOM.

Our Team

The ALIGNED study team comprises the Chief Study Investigators, the Study Steering Committee, and the Central Coordinating Centre

Learn More

Contact & Resources

If you have any questions about the ALIGNED Study or would like further information, please reach out to us.

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.

The ALIGNED Study

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

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.

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]