TY - JOUR
T1 - A New Intervention for Implementation of Pharmacogenetics in Psychiatry
T2 - A Description of the PSY-PGx Clinical Study
AU - Pelgrim, Teuntje A.D.
AU - Philipsen, Alexandra
AU - Young, Allan H.
AU - Juruena, Mario
AU - Jimenez, Ester
AU - Vieta, Eduard
AU - Jukić, Marin
AU - Van der Eycken, Erik
AU - Heilbronner, Urs
AU - Moldovan, Ramona
AU - Kas, Martien J.H.
AU - Jagesar, Raj R.
AU - Nöthen, Markus M.
AU - Hoffmann, Per
AU - Shomron, Noam
AU - Kilarski, Laura L.
AU - van Amelsvoort, Thérèse
AU - Campforts, Bea
AU - van Westrhenen, Roos
N1 - Publisher Copyright:
© 2024 by the authors.
PY - 2024/2
Y1 - 2024/2
N2 - (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.
AB - (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.
KW - anxiety disorders
KW - bipolar disorder
KW - depressive disorders
KW - mental disorders
KW - personalized medicine
KW - pharmacogenomics
KW - precision psychiatry
KW - psychopharmacology
KW - psychotic disorders
KW - schizophrenia
UR - http://www.scopus.com/inward/record.url?scp=85185965017&partnerID=8YFLogxK
U2 - 10.3390/ph17020151
DO - 10.3390/ph17020151
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C2 - 38399366
AN - SCOPUS:85185965017
SN - 1424-8247
VL - 17
JO - Pharmaceuticals
JF - Pharmaceuticals
IS - 2
M1 - 151
ER -