Will you be starting your patient on an 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 (GPs) 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. 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 direct 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.
Geographic location the project wishes to recruit from (State/Area): Participants will be recruited from the following states in Australia: NSW, VIC, WA, SA and QLD.
Name of investigators/Contact person. Highlight GP 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
Contact details: Dr Rachel McGrath, The George Institute for Global Health, Sydney Australia. Telephone: +61 2 8052 4597; Email: ALIGNED@georgeinstitute.org.au
Website link: www.alignedstudy.org.au
Brief Description of participants/practices sought (inclusion and exclusion criteria, or a hyperlink to this):
ALIGNED Participant Eligibility Criteria:
- Aged between 18 and 70 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 criteria
- A moderate to severe level of depression as rated on the Montgomery and Åsberg Depression Rating Scale (MADRS) with a score of > 19 at baseline
- Person in whom antidepressants are indicated based on the current ANZ guideline but are yet to be initiated during current episode
- Willing and able to provide informed consent
- Already taking an antidepressant
- Significant suicidal risk (as determined during screening MADRS and DSM-5 MINI assessments)
- Substance use disorder not in remission (other than nicotine or caffeine) (as determined during screening DSM-5 MINI assessments)
- Concurrent psychiatric diagnosis of bipolar disorder, or psychotic disorder (psychotic MDD, schizophrenia, schizoaffective disorder, schizophreniform disorder), or cognitive disorders (intellectual impairment/dementia) (determined by participant medical history or during screening DSM-5 MINI assessment)
- 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 11 remote (telephone or videoconference) study sessions with the ALIGNED study coordinator, carried out over 52 weeks. Participants will be required to see their GP (treating clinician) for initiation of antidepressant therapy and to attend routine follow-up visits with their GP to monitor their treatment response.