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

Perron Institute for Neurological and Translational Science0 sites60 target enrollmentJune 20, 2024

Overview

No summary available.

Registry

who.int

Start Date

June 20, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Perron Institute for Neurological and Translational Science

•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.

•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.