None listed
Conditions
Brief summary
The study involves a pilot group of up to 60 young individuals (aged 16-24) with depression, assessing the impact of PGx testing on prescribing antidepressants and collecting longitudinal data to evaluate genetic testing's utility. Insights from this study are crucial for shaping the pilot and will inform a larger clinical trial focused on the role of genetic information in optimising treatment for young people with depression. The project aims to collect empirical data to evaluate PGx testing feasibility in youth psychiatric primary care practices and support the development of sound, evidence-based treatment recommendations, using genetic insights into individual metabolic enzyme profiles.
Interventions
Upon obtaining informed consent, DNA sample will be collected from all participants in the form of a buccal swab and a blood sample for pharmacogenetic (PGx) testing at the Screening Visit. Participants who meet the selection criteria, will provide a cheek swab using the YOUTH MIND kit from Gene-S. A blood sample will also be collected, to be analysed by the PathWest laboratory.
For participants who are randomised into the intervention arm, the treatment plan for their antidepressants will be i
Upon obtaining informed consent, DNA sample will be collected from all participants in the form of a buccal swab and a blood sample for pharmacogenetic (PGx) testing at the Screening Visit. Participants who meet the selection criteria, will provide a cheek swab using the YOUTH MIND kit from Gene-S. A blood sample will also be collected, to be analysed by the PathWest laboratory. For participants who are randomised into the intervention arm, the treatment plan for their antidepressants will be informed by the participant’s PGx report. This report provides recommendations for antidepressant prescribing that are guided by the participant's PGx profile, in accordance with Therapeutic Goods Administration (TGA) recommended doses. The recommendations regarding the class of antidepressant and dosage are based on guidelines from the Clinical Pharmacogenetics Implementation Consortium (CPIC) and the Royal Dutch Pharmacogenetics Working Group (DPWG). The treatment guide will be provided by a psychiatrist from the research team and sent to the participants General Practitioner (GP). Participants in the control group will receive a treatment guide based on the current clinical guidelines, prepared by a psychiatrist on the research team. Both the participant and their GP will be blinded. Treatment initiation for all participants will occur within four weeks following the Screening Visit. During the Screening Visit, the research team will advise the participant to schedule and appointment with their GP within 1-4 weeks, in which time the PGx report and treatment guide will be prepared and sent to their nominated GP. Reviews of participants will be conducted at 6, and 12 weeks after the initiation of treatment. The adherence of participants to the antidepressant treatment will be reviewed by the Investigators using the Medication Adherence Report Scale (MARS-5). Medications recommended for both groups will comply with current TGA guidelines.
Sponsors
Perron Institute for Neurological and Translational Science
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
Participants may be included in this study if: 1. Participants are aged between 16 to 24 years (inclusive). 2. Participants are able to give informed consent. 3. Participants are fluent in English (to the level of being able to understand the Participant Information and Consent Form and engage with research staff). 4. Participants are diagnosed with major depressive disorder (MDD), either first-episode or relapsed, on Mini International Neuropsychiatric Interview (M.I.N.I.) 7.0.2 for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria.
Exclusion criteria
Participants will be excluding from participating in this study if: 1. Participant displays significant suicidal risk based on Montgomery-Åsberg Depression Rating Scale (MADRS) and/or DSM-V M.I.N.I. 2. Participant displays signs of a substance use disorder not in remission (other than nicotine or caffeine), as determined during DSM-V M.I.N.I. screening assessment. 3. Participant is diagnosed with a concurrent psychiatric diagnosis of any one or more of the following: bipolar disorder, psychotic disorders (psychotic MDD, schizophrenia, schizoaffective disorder, schizophreniform disorder), or cognitive disorders (dementia), as determined by participant medical history or during DSM-V M.I.N.I. screening assessment. 4. Participants have experienced the failure of 2 or more prior adequate trials (at least 6 weeks at a minimum effective dose) of evidenced-based pharmacological treatments, in their current MDD episode. 5. Participant has a history of significant hepatic or renal disease affecting drug metabolism. 6. Participant is a pregnant or breast-feeding woman. 7. Adults (18 – 24 years old) that are not able to provide consent for participation.
Outcome results
None listed