To access the full text documents, please follow this link: http://hdl.handle.net/2445/121741
dc.contributor.author | Pérez, Víctor |
---|---|
dc.contributor.author | Salavert, Ariana |
dc.contributor.author | Espadaler, Jordi |
dc.contributor.author | Tuson, Miquel |
dc.contributor.author | Saiz Ruiz, Jerónimo |
dc.contributor.author | Sáez Navarro, Cristina |
dc.contributor.author | Bobes García, Julio |
dc.contributor.author | Baca García, Enrique |
dc.contributor.author | Vieta i Pascual, Eduard, 1963- |
dc.contributor.author | Olivares, José M. |
dc.contributor.author | Rodriguez Jimenez, Roberto |
dc.contributor.author | Villagrán, José M. |
dc.contributor.author | Gascón, Josep |
dc.contributor.author | Cañete Crespillo, Josep |
dc.contributor.author | Solé, Montse |
dc.contributor.author | Saiz, Pilar A. |
dc.contributor.author | Ibáñez, Ángela |
dc.contributor.author | Diego Adeliño, Javier de |
dc.contributor.author | Menchón Magriñá, José Manuel |
dc.contributor.author | AB-GEN Collaborative Group |
dc.date | 2018-04-20T13:42:24Z |
dc.date | 2018-04-20T13:42:24Z |
dc.date | 2017-07-14 |
dc.date | 2018-04-20T13:42:24Z |
dc.identifier | 1471-244X |
dc.identifier | 673000 |
dc.identifier | 28705252 |
dc.identifier.uri | http://hdl.handle.net/2445/121741 |
dc.description | 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]). |
dc.format | 13 p. |
dc.format | application/pdf |
dc.language | eng |
dc.publisher | BioMed Central |
dc.relation | Reproducció del document publicat a: https://doi.org/10.1186/s12888-017-1412-1 |
dc.relation | BMC Psychiatry, 2017, vol. 17, num. 250 |
dc.relation | https://doi.org/10.1186/s12888-017-1412-1 |
dc.rights | cc-by (c) Pérez, Víctor et al., 2017 |
dc.rights | http://creativecommons.org/licenses/by/3.0/es |
dc.rights | info:eu-repo/semantics/openAccess |
dc.subject | Malalties mentals |
dc.subject | Farmacogenètica |
dc.subject | Mental illness |
dc.subject | Pharmacogenetics |
dc.title | Efficacy of prospective pharmacogenetic testing in the treatment of major depressive disorder: results of a randomized, double-blind clinical trial |
dc.type | info:eu-repo/semantics/article |
dc.type | info:eu-repo/semantics/publishedVersion |