Short description of the project and method:
Will you be starting your patient on an antidepressant or considering switching to a different antidepressant? If so, this study may be of benefit to you and your patient.
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.
Study participants are randomised to either the pharmacogenomics-guided intervention arm or a standard care (control) arm. The prescribing doctors (Participant’s treating clinician – i.e. GP/Psychiatrist) 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. Participants will be followed up for 12 weeks with assessments at Baseline, Week 6 and Week 12. 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 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.
The study is conducted remotely, whereby participant screening and assessments conducted via Videoconference/Phone calls. Participants are recruited from across Australia.
Study Website link:
https://www.alignedstudy.org.au/
Contact details:
Contact person for scientific queries: A/Prof Kathy Wu
Telephone: +61 2 8382 4899
Email: Kathy.wu@svha.org.au
Contact person for public queries: Dr Niru Wijesuriya
Telephone: +61 2 8052 4300
Email: nwijesuriya@georgeinstitute.org.au
Geographic location the project wishes to recruit from (State/Area):
All states in Australia
Brief Description of participants/practices sought:
Inclusion criteria:
- Aged between 18 and 80 years (inclusive)
- Sufficiently fluent in English
- Diagnosed with Major Depressive Disorder, either first-episode or relapsed, on the Mini-International Neuropsychiatric Interview Diagnostic and Statistical Manual of Mental Disorders (DSM- 5) Mini criteria
- Person in whom antidepressants are indicated based on the current ANZ guideline but are yet to be initiated during current episode OR planning to switch antidepressant treatment in current episode
- Willing and able to consent to participate in the study
Exclusion criteria:
- Intellectual impairment or dementia limiting capacity to provide informed consent
- Current history of hepatic or renal failure confounding drug metabolism
- Contraindication, including hypersensitivity (e.g. anaphylaxis), to SSRI, SNRI, mirtazapine and moclobemide.
- Pregnant or breast-feeding.
Time involvement of GPs and/or practice staff, and/or patients:
Study participants will attend 4 remote (telephone or videoconference) study sessions with the ALIGNED study coordinator, carried out over 12 weeks. Participants will be required to see their treating clinician for initiation of antidepressant therapy and to attend routine follow-up visits with their GP as per standard practice to monitor their treatment response.
Availability of CPD points:
A statement of attendance will be provided to all attendees, which attendees could use to self-claim CPD hours
Name of investigators.
Lead Investigator: Associate Professor Kathy Wu, St Vincent’s Hospital, Sydney, Australia
Principal Investigator: Professor Paul Fitzgerald, Monash University, Melbourne, Australia
Principal Investigator: Professor Anthony Rodgers, The George Institute for Global Health, Australia
Principal Investigator: Professor Sean Hood, University of Western Australia, Perth, Australia
Principal Investigator: Professor Anthony Harris, University of Sydney, Sydney, Australia
GP Principal Investigator: Professor Tim Usherwood, University of Sydney, Sydney, Australia
GP Principal Investigator: Dr Jacquie Garton-Smith, Royal Perth Hospital, Perth, Australia
Clinical trial registration if applicable:
ACTRN12621000926831p
Closing date for recruitment:
31-Dec-2024