A New Intervention for Implementation of Pharmacogenetics in Psychiatry: A Description of the PSY-PGx Clinical Study.

Autor: Pelgrim TAD; Department of Psychiatry, Parnassia Psychiatric Institute, 1062HN Amsterdam, The Netherlands., Philipsen A; Department of Psychiatry and Psychotherapy, University of Bonn, 53105 Bonn, Germany., Young AH; Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London & South London and Maudsley NHS Foundation Trust, Bethlem Royal Hospital, Monks Orchard Road Beckenham, Kent BR3 3BX, UK., Juruena M; Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London & South London and Maudsley NHS Foundation Trust, Bethlem Royal Hospital, Monks Orchard Road Beckenham, Kent BR3 3BX, UK., Jimenez E; Bipolar and Depressive Disorders Unit, Department of Psychiatry and Psychology, Hospital Clinic & Institute of Neurosciences (UBNeuro), IDIBAPS, CIBERSAM, ISCIII, University of Barcelona, 08036 Catalonia, Spain., Vieta E; Bipolar and Depressive Disorders Unit, Department of Psychiatry and Psychology, Hospital Clinic & Institute of Neurosciences (UBNeuro), IDIBAPS, CIBERSAM, ISCIII, University of Barcelona, 08036 Catalonia, Spain., Jukić M; Department of Physiology, Faculty of Pharmacy, University of Belgrade, 11000 Belgrade, Serbia.; Department of Physiology & Pharmacology, Karolinska Institute, 171 77 Stockholm, Sweden., Van der Eycken E; Global Alliance of Mental Illness Advocacy Networks-Europe (GAMIAN-Europe), 1050 Brussels, Belgium., Heilbronner U; Institute of Psychiatric Phenomics and Genomics (IPPG), LMU University Hospital, LMU Munich, 80336 Munich, Germany., Moldovan R; Department of Psychology, Babeş-Bolyai University, 400015 Cluj-Napoca, Romania.; Division of Evolution, Infection and Genomic Sciences, School of Biological Sciences, University of Manchester, Manchester M13 9PT, UK.; Manchester Center for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, Manchester M13 9WL, UK., Kas MJH; Groningen Institute for Evolutionary Life Sciences, University of Groningen, 9700CC Groningen, The Netherlands., Jagesar RR; Groningen Institute for Evolutionary Life Sciences, University of Groningen, 9700CC Groningen, The Netherlands., Nöthen MM; Institute of Human Genetics, University Hospital of Bonn and University of Bonn, 53127 Bonn, Germany., Hoffmann P; Institute of Human Genetics, University Hospital of Bonn and University of Bonn, 53127 Bonn, Germany., Shomron N; Faculty of Medicine, Tel Aviv University, Tel Aviv 69978, Israel., Kilarski LL; Department of Psychiatry and Psychotherapy, University of Bonn, 53105 Bonn, Germany., van Amelsvoort T; Department of Psychiatry and Neuropsychology, Maastricht University, 6226NB Maastricht, The Netherlands., Campforts B; Department of Psychiatry and Neuropsychology, Maastricht University, 6226NB Maastricht, The Netherlands., The Psy-PGx Consortium, van Westrhenen R; Department of Psychiatry, Parnassia Psychiatric Institute, 1062HN Amsterdam, The Netherlands.; Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London & South London and Maudsley NHS Foundation Trust, Bethlem Royal Hospital, Monks Orchard Road Beckenham, Kent BR3 3BX, UK.; Department of Psychiatry and Neuropsychology, Maastricht University, 6226NB Maastricht, The Netherlands.; St. John's National Academy of Health Sciences, Bangalore 560034, India.
Jazyk: angličtina
Zdroj: Pharmaceuticals (Basel, Switzerland) [Pharmaceuticals (Basel)] 2024 Jan 23; Vol. 17 (2). Date of Electronic Publication: 2024 Jan 23.
DOI: 10.3390/ph17020151
Abstrakt: (1) Background Pharmacological treatment for psychiatric disorders has shown to only be effective in about one-third of patients, as it is associated with frequent treatment failure, often because of side effects, and a long process of trial-and-error pharmacotherapy until an effective and tolerable treatment is found. This notion emphasizes the urgency for a personalized medicine approach in psychiatry. (2) Methods This prospective patient- and rater-blinded, randomized, controlled study will investigate the effect of dose-adjustment of antidepressants escitalopram and sertraline or antipsychotics risperidone and aripiprazole according to the latest state-of-the-art international dosing recommendations for CYP2C19 and CYP2D6 metabolizer status in patients with mood, anxiety, and psychotic disorders. A total sample of N = 2500 will be recruited at nine sites in seven countries (expected drop-out rate of 30%). Patients will be randomized to a pharmacogenetic group or a dosing-as-usual group and treated over a 24-week period with four study visits. The primary outcome is personal recovery using the Recovery Assessment Scale as assessed by the patient (RAS-DS), with secondary outcomes including clinical effects (response or symptomatic remission), side effects, general well-being, digital phenotyping, and psychosocial functioning. (3) Conclusions This is, to our knowledge, the first international, multi-center, non-industry-sponsored randomized controlled trial (RCT) that may provide insights into the effectiveness and utility of implementing pharmacogenetic-guided treatment of psychiatric disorders, and as such, results will be incorporated in already available dosing guidelines.
Databáze: MEDLINE
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