When might the ALIGNED trial be suitable?

The following examples illustrate potential scenarios where this trial* may help a person who requires medication to treat depression

*All participants in the ALIGNED trial will undergo pharmacogenomics testing. However, as this trial is a double-blind randomised controlled study, only those participants randomised to the intervention group will have their antidepressant treatment tailored to pharmacogenomics, whereas those randomised to the control group will receive standard antidepressant treatment, for the first three months. At week 12, every participant will receive a copy of their pharmacogenomics report through their GP, after which, the participants have the discretion of whether to discuss the report with their treating physician and/or use it to plan their ongoing treatment.

Carol is a 35-year-old professional artist who is previously well with no medical or mental health history.

Carol develops depression during the COVID pandemic lockdown. As she has never taken regular medications and is generally averse to taking any pharmacotherapy, Carol is hesitant when her GP mentions antidepressant therapy. Carol opts to trial psychology counselling support before starting antidepressant treatment if her symptoms do not improve. After six sessions with the psychologist, Carol returns to see her GP to discuss starting an antidepressant. Carol has come across pharmacogenomics in her reading about depression treatment and feels more confident in taking medication that is tailored to her genetic makeup. Carol discusses testing with her GP to personalise antidepressant therapy.

Charlie is a 28-year-old non-binary mature-aged University student who is studying law and has a strong family history of mental distress.

Charlie’s older brother did not respond to medications for severe depression and ended up in hospital for a long time, and Charlie’s aunt and cousin have been diagnosed with bipolar affective disorder. Charlie develops symptoms of depression, however, as the GP is not confident to exclude bipolar disorder, Charlie is referred to a psychiatrist. The psychiatrist diagnoses Charlie with Major Depressive Disorder. Charlie is keen to determine the best treatment as soon as possible to minimise disruption to their study. The psychiatrist considers pharmacogenomics to individualise drug choice and dosing to optimise Charlie’s chance of response and recovery.

Alex is a 56-year-old computer programmer who has a history of recurrent depression.

He has trialled many different antidepressants in the past and while some helped, he disliked taking them due to significant adverse effects. He experiences another episode of depression triggered by relationship breakdown. He sees his GP, who discusses pharmacogenomics testing with Alex to better guide drug therapy to improve medication tolerability.

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]