Eligibility Criteria
To be eligible to take part in the study, you will:
- Be aged 18 to 70
- Live in NSW, ACT, QLD, SA, VIC or WA
- Have moderate to severe depression
- Not currently taking antidepressant medication (although you can have taken it in the past)
- 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). It 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 9 study sessions over a period of approximately 24 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.
Overview of study videoconference sessions
Expression of interest
Quick screen to check that you can join the study
online
Pre-Screening
Informed consent, detailed check that you can join the study
Telephone call
Screening
Assessment of depressive sypmtoms questionnaires
Online and videoconference interview
Collect cheek swab sample at home
Collected by courier for transport to laboratory
Baseline
Questionnaires, interview
Online and videoconference interview
Randomisation to pharmacogenomic- informed or standard treatment
MRI brain
Optional component; available only at limited locations
VIsit to hospital for an MRI scan
Study sessions
At week 2, 4, 8, 12 and 24.
Questionnaires and interviews
GP visits at week 2 and 4
Online and videoconference interview