TY  - JOUR
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
PY  - 2024
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/5548
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.
PB  - MDPI
T2  - Pharmaceuticals
T1  - A New Intervention for Implementation of Pharmacogenetics in Psychiatry: A Description of the PSY-PGx Clinical Study
VL  - 17
IS  - 2
SP  - 151
DO  - 10.3390/ph17020151
ER  - 

@article{
author = "Pelgrim, Teuntje A. D. and Philipsen, Alexandra and Young, Allan H. and Juruena, Mario and Jimenez, Ester and Vieta, Eduard and Jukić, Marin and Van der Eycken, Erik and Heilbronner, Urs and Moldovan, Ramona and Kas, Martien J. H. and Jagesar, Raj R. and Nöthen, Markus M. and Hoffmann, Per and Shomron, Noam and Kilarski, Laura L and van Amelsvoort, Thérèse and Campforts, Bea and van Westrhenen, Roos",
year = "2024",
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.",
publisher = "MDPI",
journal = "Pharmaceuticals",
title = "A New Intervention for Implementation of Pharmacogenetics in Psychiatry: A Description of the PSY-PGx Clinical Study",
volume = "17",
number = "2",
pages = "151",
doi = "10.3390/ph17020151"
}

Pelgrim, T. A. D., Philipsen, A., Young, A. H., Juruena, M., Jimenez, E., Vieta, E., Jukić, M., Van der Eycken, E., Heilbronner, U., Moldovan, R., Kas, M. J. H., Jagesar, R. R., Nöthen, M. M., Hoffmann, P., Shomron, N., Kilarski, L. L., van Amelsvoort, T., Campforts, B.,& van Westrhenen, R.. (2024). A New Intervention for Implementation of Pharmacogenetics in Psychiatry: A Description of the PSY-PGx Clinical Study. in Pharmaceuticals
MDPI., 17(2), 151.
https://doi.org/10.3390/ph17020151

Pelgrim TAD, Philipsen A, Young AH, Juruena M, Jimenez E, Vieta E, Jukić M, Van der Eycken E, Heilbronner U, Moldovan R, Kas MJH, Jagesar RR, Nöthen MM, Hoffmann P, Shomron N, Kilarski LL, van Amelsvoort T, Campforts B, van Westrhenen R. A New Intervention for Implementation of Pharmacogenetics in Psychiatry: A Description of the PSY-PGx Clinical Study. in Pharmaceuticals. 2024;17(2):151.
doi:10.3390/ph17020151 .

Pelgrim, Teuntje A. D., Philipsen, Alexandra, Young, Allan H., Juruena, Mario, Jimenez, Ester, Vieta, Eduard, Jukić, Marin, Van der Eycken, Erik, Heilbronner, Urs, Moldovan, Ramona, Kas, Martien J. H., Jagesar, Raj R., Nöthen, Markus M., Hoffmann, Per, Shomron, Noam, Kilarski, Laura L, van Amelsvoort, Thérèse, Campforts, Bea, van Westrhenen, Roos, "A New Intervention for Implementation of Pharmacogenetics in Psychiatry: A Description of the PSY-PGx Clinical Study" in Pharmaceuticals, 17, no. 2 (2024):151,
https://doi.org/10.3390/ph17020151 . .