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

Teuntje A D Pelgrim, Alexandra Philipsen, Allan H Young, Mario Juruena, Ester Jimenez, Eduard Vieta, Marin Jukić, Erik Van der Eycken, Urs Heilbronner, Ramona Moldovan, Martien J H Kas, Raj R Jagesar, Markus M Nöthen, Per Hoffmann, Noam Shomron, Laura L Kilarski, Thérèse van Amelsvoort, Bea Campforts, The IMAGEN The Psy-PGx Consortium, Roos van Westrhenen

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Abstract

(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.

Original languageEnglish
Article number151
JournalPharmaceuticals
Volume17
Issue number2
DOIs
Publication statusPublished - 23 Jan 2024

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