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

• Main Authors: Teuntje A. D. Pelgrim (Author), Alexandra Philipsen (Author), Allan H. Young (Author), Mario Juruena (Author), Ester Jimenez (Author), Eduard Vieta (Author), Marin Jukić (Author), Erik Van der Eycken (Author), Urs Heilbronner (Author), Ramona Moldovan (Author), Martien J. H. Kas (Author), Raj R. Jagesar (Author), Markus M. Nöthen (Author), Per Hoffmann (Author), Noam Shomron (Author), Laura L. Kilarski (Author), Thérèse van Amelsvoort (Author), Bea Campforts (Author), The PSY-PGx Consortium (Author), Roos van Westrhenen (Author)
• Format: Book
• Published: MDPI AG, 2024-01-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Summary

<b>(1) Background</b> 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. <b>(2) Methods</b> This prospective patient- and rater-blinded, randomized, controlled study will investigate the effect of dose-adjustment of antidepressants <i>escitalopram</i> and <i>sertraline</i> or antipsychotics <i>risperidone</i> and <i>aripiprazole</i> according to the latest state-of-the-art international dosing recommendations for <i>CYP2C19</i> and <i>CYP2D6</i> 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. <b>(3) Conclusions</b> 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.

Item Description

10.3390/ph17020151
1424-8247