A New Intervention for Implementation of Pharmacogenetics in Psychiatry: A Description of the PSY-PGx Clinical Study
Аутори
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
Чланак у часопису (Објављена верзија)
Метаподаци
Приказ свих података о документуАпстракт
(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 g...roup 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.
Кључне речи:
personalized medicine / pharmacogenomics / anxiety disorders / bipolar disorder / depressive disorders / mental disorders / precision psychiatry / psychopharmacology / psychotic disorders / schizophreniaИзвор:
Pharmaceuticals, 2024, 17, 2, 151-Издавач:
- MDPI
Финансирање / пројекти:
- The European Union’s Horizon 2020 research
- Innovation program under grant agreement No 945151 (chief principal investigator: R.v.W.; Work Package Leaders R.v.W., M.J., R.M., J.K., A.Y., M.J., J.K., N.S. and U.H.)
DOI: 10.3390/ph17020151
ISSN: 1424-8247
PubMed: 38399366
WoS: 001173103600001
Scopus: 2-s2.0-85185965017
Институција/група
PharmacyTY - 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 . .
Related items
Showing items related by title, author, creator and subject.
-
Assessing the symptoms of Internet Gaming Disorder among college/university students: An international validation study of a self-report / Procenjivanje simptoma poremećaja igranja kompjuterskih igara na internetu (eng. Internet Gaming Disorder) kod studenata - internacionalna validaciona studija mere samoprocene
Stevanović, Dejan; Đorić, Ana; Singh Balhara, Yatan Pal; Ćirović, Nikola; Arya, Sidharth; Ransing, Ramdas; Vu Thi, Tuong – Vi; Huong, Truong Ngoc; Tadić, Ivana; Jović, Jelena; Radovanović, Saša; Kafali, Helin Yilmaz; Erzin, Gamze; Vally, Zahir; Chowdhury, Mita Rani Roy; Sharma, Pawan; Shakya, Rabi; Moreira, Paulo; Olayinka, Atilola; Mohamad, Avicenna; Campos, Luís Antônio Monteiro; Campos, Pedro de Abreu Monteiro; Silva, Cristiane Moreira; Tavares, Jose Carlos; Buoli, Massimiliano; Burkauskas, Julius; Ivanović, Iva; Szczegielniak, Anna Rebeka; Knez, Rajna (Beograd : Društvo psihologa Srbije, 2020) -
Abnormal development of monoaminergic neurons is implicated in mood fluctuations and bipolar disorder
Jukić, Marin; Carrillo-Roa, T; Bar, M; Becker, G; Jovanović, V.M; Zega, K; Binder, E.B; Brodski, C (Nature Publishing Group, 2015) -
Biomarkers for Major Depressive Disorder: Economic Considerations
Bogavac-Stanojević, Nataša; Lakić, Dragana (Wiley, Hoboken, 2016)