Information for Participants

Eligibility Criteria

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 antidepressant
Be willing to consider antidepressant medication treatment

What Participation Involves

The ALIGNED Study will be conducted in conjunction 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. All participants will have pharmacogenomic testing and will then be randomly allocated to the pharmacogenomic-informed treatment group or standard treatment group. Neither you nor your doctor will know which treatment group you have been assigned to.

There are 4 study sessions over a period of approximately 3 months (12 weeks).
All sessions will be done by videoconference e.g., ZOOM. Some sessions will include questions about your health and current medications and others will comprise an interview to determine your depression symptoms. To take part in the study, you will need access to a smart phone, tablet or computer with internet access. We can reimburse you for expenditure related to data requirements for attending study videoconference sessions if needed.

See below for an overview of study assessment sessions:

Submitting Expression of Interest (via Website)

Pre-Screening (via Phone call with Study Coordinator) &Pharmacogenomic (PG) testing

Informed Consent and Screening (via videoconference)

Baseline Assessment (via videoconference + survey questionnaires)

Randomisation to PG- informed or Standard treatment

MRI Brain (optional component; available only at limited locations)

Study Assessments at Weeks 6 & 12 (via Phone calls/videoconference + survey questionnaires)

+ GP visits to start treatment & follow up at week 2

Download a copy of the Participant Information Sheet and Consent Form

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
ALIGNED@georgeinstitute.org.au

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: privacy@georgeinstitute.org