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A New Intervention for Implementation of Pharmacogenetics in Psychiatry: A Description of the PSY-PGx Clinical Study
dc.creator | Pelgrim, Teuntje A. D. | |
dc.creator | Philipsen, Alexandra | |
dc.creator | Young, Allan H. | |
dc.creator | Juruena, Mario | |
dc.creator | Jimenez, Ester | |
dc.creator | Vieta, Eduard | |
dc.creator | Jukić, Marin | |
dc.creator | Van der Eycken, Erik | |
dc.creator | Heilbronner, Urs | |
dc.creator | Moldovan, Ramona | |
dc.creator | Kas, Martien J. H. | |
dc.creator | Jagesar, Raj R. | |
dc.creator | Nöthen, Markus M. | |
dc.creator | Hoffmann, Per | |
dc.creator | Shomron, Noam | |
dc.creator | Kilarski, Laura L | |
dc.creator | van Amelsvoort, Thérèse | |
dc.creator | Campforts, Bea | |
dc.creator | van Westrhenen, Roos | |
dc.date.accessioned | 2024-03-05T09:28:34Z | |
dc.date.available | 2024-03-05T09:28:34Z | |
dc.date.issued | 2024 | |
dc.identifier.issn | 1424-8247 | |
dc.identifier.uri | https://farfar.pharmacy.bg.ac.rs/handle/123456789/5548 | |
dc.description.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. | |
dc.publisher | MDPI | |
dc.relation | The European Union’s Horizon 2020 research | |
dc.relation | 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.) | |
dc.rights | openAccess | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0/ | |
dc.source | Pharmaceuticals | |
dc.subject | personalized medicine | |
dc.subject | pharmacogenomics | |
dc.subject | anxiety disorders | |
dc.subject | bipolar disorder | |
dc.subject | depressive disorders | |
dc.subject | mental disorders | |
dc.subject | precision psychiatry | |
dc.subject | psychopharmacology | |
dc.subject | psychotic disorders | |
dc.subject | schizophrenia | |
dc.title | A New Intervention for Implementation of Pharmacogenetics in Psychiatry: A Description of the PSY-PGx Clinical Study | |
dc.type | article | |
dc.rights.license | BY | |
dc.citation.volume | 17 | |
dc.citation.issue | 2 | |
dc.citation.spage | 151 | |
dc.identifier.wos | 001173103600001 | |
dc.identifier.doi | 10.3390/ph17020151 | |
dc.identifier.pmid | 38399366 | |
dc.identifier.scopus | 2-s2.0-85185965017 | |
dc.identifier.fulltext | http://farfar.pharmacy.bg.ac.rs/bitstream/id/15637/A_New_Intervention_pub_2024.pdf | |
dc.type.version | publishedVersion |