Pérez, VíctorSalavert, ArianaEspadaler, JordiTuson, MiquelSaiz Ruiz, JerónimoSáez Navarro, CristinaBobes García, JulioBaca García, EnriqueVieta i Pascual, Eduard, 1963-Olivares, José M.Rodriguez Jimenez, RobertoVillagrán, José M.Gascón, JosepCañete Crespillo, JosepSolé, MontseSaiz, Pilar A.Ibáñez, ÁngelaDiego Adeliño, Javier deMenchón Magriñá, José ManuelAB-GEN Collaborative Group2018-04-202018-04-202017-07-141471-244Xhttps://hdl.handle.net/2445/121741Background: 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]).13 p.application/pdfengcc-by (c) Pérez, Víctor et al., 2017http://creativecommons.org/licenses/by/3.0/esMalalties mentalsFarmacogenèticaMental illnessPharmacogeneticsinfo:eu-repo/semantics/article6730002018-04-20info:eu-repo/semantics/openAccess28705252