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Title: | Efficacy of prospective pharmacogenetic testing in the treatment of major depressive disorder: results of a randomized, double-blind clinical trial |
Author: | Pérez, Víctor Salavert, Ariana Espadaler, Jordi Tuson, Miquel Saiz Ruiz, Jerónimo Sáez Navarro, Cristina Bobes García, Julio Baca García, Enrique Vieta i Pascual, Eduard, 1963- Olivares, José M. Rodriguez Jimenez, Roberto Villagrán, José M. Gascón, Josep Cañete Crespillo, Josep Solé, Montse Saiz, Pilar A. Ibáñez, Ángela Diego Adeliño, Javier de Menchón Magriñá, José Manuel AB-GEN Collaborative Group |
Keywords: | Malalties mentals Farmacogenètica Mental illness Pharmacogenetics |
Issue Date: | 14-Jul-2017 |
Publisher: | BioMed Central |
Abstract: | Background: A 12-week, double-blind, parallel, multi-center randomized controlled trial in 316 adult patients with major depressive disorder (MDD) was conducted to evaluate the effectiveness of pharmacogenetic (PGx) testing for drug therapy guidance. Methods: Patients with a CGI-S ≥ 4 and requiring antidepressant medication de novo or changes in their medication regime were recruited at 18 Spanish public hospitals, genotyped with a commercial PGx panel (Neuropharmagen®), and randomized to PGx-guided treatment (n = 155) or treatment as usual (TAU, control group, n = 161), using a computer-generated random list that locked or unlocked psychiatrist access to the results of the PGx panel depending on group allocation. The primary endpoint was the proportion of patients achieving a sustained response (Patient Global Impression of Improvement, PGI-I ≤ 2) within the 12-week follow-up. Patients and interviewers collecting the PGI-I ratings were blinded to group allocation. Between-group differences were evaluated using χ2-test or t-test, as per data type. Results: Two hundred eighty patients were available for analysis at the end of the 12-week follow-up (PGx n = 136, TAU n = 144). A difference in sustained response within the study period (primary outcome) was not observed (38.5% vs 34.4%, p = 0.4735; OR = 1.19 [95%CI 0.74-1.92]), but the PGx-guided treatment group had a higher responder rate compared to TAU at 12 weeks (47.8% vs 36.1%, p = 0.0476; OR = 1.62 [95%CI 1.00-2.61]), and this difference increased after removing subjects in the PGx-guided group when clinicians explicitly reported not to follow the test recommendations (51.3% vs 36.1%, p = 0.0135; OR = 1.86 [95%CI 1.13-3.05]). Effects were more consistent in patients with 1-3 failed drug trials. In subjects reporting side effects burden at baseline, odds of achieving a better tolerability (Frequency, Intensity and Burden of Side Effects Rating Burden subscore ≤2) were higher in the PGx-guided group than in controls at 6 weeks and maintained at 12 weeks (68.5% vs 51.4%, p = 0.0260; OR = 2.06 [95%CI 1.09-3.89]). |
Note: | Reproducció del document publicat a: https://doi.org/10.1186/s12888-017-1412-1 |
It is part of: | BMC Psychiatry, 2017, vol. 17, num. 250 |
URI: | http://hdl.handle.net/2445/121741 |
Related resource: | https://doi.org/10.1186/s12888-017-1412-1 |
ISSN: | 1471-244X |
Appears in Collections: | Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer) Articles publicats en revistes (Ciències Clíniques) Articles publicats en revistes (Medicina) Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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