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, Roos van Westrhenen*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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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
Number of pages15
JournalPharmaceuticals
Volume17
Issue number2
DOIs
Publication statusPublished - Feb-2024

Keywords

  • anxiety disorders
  • bipolar disorder
  • depressive disorders
  • mental disorders
  • personalized medicine
  • pharmacogenomics
  • precision psychiatry
  • psychopharmacology
  • psychotic disorders
  • schizophrenia

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