Clinical Study Evaluating Pharmacogenomics-informed Pharmacotherapy Versus Dosing as Usual in Psychiatric Disorders
Start Date
2/23/2023
Completion Date
9/1/2026
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.
Detailed 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 first initiative to propose a large-scale non-industry sponsored clinical study that aims to demonstrate the clinical benefits and potential of the implementation of pharmacogenetics for psychiatric patients in existing medical settings. This is an international 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.
Eligibility Criteria
Age Range: 16 years to 70 years
Interventions
Personalised medication advice based on pharmacogenetic testing
Conditions
Locations
SUNY Upstate Medical University, Department of Psychiatry and Behavioural Sciences
Syracuse, New York 13210
United States
University Hospital Bonn, Department of Psychiatry and Psychotherapy
Bonn,
Germany
Ludwig-Maximilian University, University Hospital, Institute of Psychiatric Phenomics and Genomics (IPPG)
München,
Germany
Parnassia Psychiatric Institute, Department of Psychiatry
Amsterdam,
Netherlands
Maastricht University, Department of Psychiatry and Neuropsychology
Maastricht,
Netherlands
Babeş-Bolyai University, Department of Clinical Psychology and Psychotherapy
Cluj-Napoca,
Romania
University of Belgrade, Faculty of Pharmacy
Belgrade,
Serbia
Fundació Clínic per a la Recerca Biomèdica, Department of Psychiatry and Psychology, Hospital Clínic
Barcelona,
Spain
King's College, Institute of Psychiatry, Psychology & Neuroscience
London,
United Kingdom