RecruitingACTRN12624000760572

Gene-YD – PharmacoGENEtics in Youth Depression

Improving mental health outcomes in Youth: Tailoring antidepressant treatment based on how individual people metabolise medicines using pharmacogenetic testing. Pilot Trial


Sponsor

Perron Institute for Neurological and Translational Science

Enrollment

80 participants

Start Date

Aug 16, 2024

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 16 YearssMax Age: 24 Yearss

Plain Language Summary

Simplified for easier understanding

When a young person is diagnosed with depression, finding the right antidepressant can sometimes feel like guesswork. Different people process medications at different rates depending on their genetic makeup, and a dose that works perfectly for one person may be too high or too low for another. Pharmacogenomic (PGx) testing is a type of genetic test that can reveal how your body metabolises certain medications — potentially helping doctors choose the right medication and dose from the start. This pilot study is exploring whether PGx testing is practical and useful in real-world youth mental health settings. Young people with depression will have genetic testing, and researchers will follow their treatment journey to see whether the test results help guide prescribing decisions and improve outcomes. You may be eligible if you are aged 16 to 24 and have recently been diagnosed with major depressive disorder for the first time, or are experiencing a relapse. You must be fluent in English and able to provide informed consent. People with bipolar disorder, psychosis, or a history of two or more treatment failures are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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. Participan

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.


Locations(1)

WA, Australia

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ACTRN12624000760572