A New Intervention for Implementation of Pharmacogenetics in Psychiatry
Maastricht University Medical Center
Summary
A 24-week, patient- and rater-blinded, two-arm, parallel-group controlled, and multi-centre randomized clinical trial (RCT) to establish the benefits of pharmacogenetics-informed pharmacotherapy versus dosing as usual (DAU) in psychiatric patients suffering from mood, anxiety, or psychotic disorders.
Description
Effective pharmacotherapeutic treatments for mental disorders are available, but their effectiveness is limited by low compliance due to frequent side effects. This is partly due to patient heterogeneity in the genes encoding for drug-metabolising enzymes. Pharmacogenetic testing allows the assessment of person-specific genetic factors that are thought to predict clinical response and side effects. Recent studies have suggested that genotyping genes encoding drug-metabolizing enzymes may improve treatment efficacy and tolerability, potentially benefitting millions of patients. PSY-PGx is the…
Eligibility
- Age range
- 16–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Suffer from a depressive episode (major depressive disorder and bipolar disorder (currently depressive episode)) (as assessed by the MINI International Neuropsychiatric Interview (M.I.N.I.) in agreement with Diagnostic and Statistical Manual (DSM-5 criteria) of at least moderate severity (assessed using the Structured Interview Guide for the Hamilton Depression Scale (SIGH-D) with a score of 14 or higher) and/or suffer from an anxiety disorder (panic disorder, generalised anxiety disorder) (as assessed by the M.I.N.I. in agreement with DSM-5 criteria) of at least modera…
Interventions
- OtherPersonalised medication advice based on pharmacogenetic testing
Pharmacogenetic genotyping provides personalised medication advice on dosage and choice of currently available and legally approved medication based on the patient's pharmacogenetic profile
Locations (9)
- SUNY Upstate Medical University, Department of Psychiatry and Behavioural SciencesSyracuse, New York
- University Hospital Bonn, Department of Psychiatry and PsychotherapyBonn
- Ludwig-Maximilian University, University Hospital, Institute of Psychiatric Phenomics and Genomics (IPPG)München
- Parnassia Psychiatric Institute, Department of PsychiatryAmsterdam
- Maastricht University, Department of Psychiatry and NeuropsychologyMaastricht
- Babeş-Bolyai University, Department of Clinical Psychology and PsychotherapyCluj-Napoca