Efficacy of prospective pharmacogenetic testing in the treatment of major depressive disorder: results of a randomized, double-blind clinical trial

Pérez Solá, Victor; Salavert, Ariana; Espadaler, Jordi; Tusón, Miquel; Saiz-Ruiz, Jerónimo; Sáez-Navarro, Cristina; Bobes, Julio; Baca-García, Enrique; 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; AB-GEN Collaborative Group; Menchón, José M.

Efficacy of prospective pharmacogenetic testing in the treatment of major depressive disorder: results of a randomized, double-blind clinical trial

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dc.contributor.author Pérez Solá, Victorca
dc.contributor.author Salavert, Arianaca
dc.contributor.author Espadaler, Jordica
dc.contributor.author Tusón, Miquelca
dc.contributor.author Saiz-Ruiz, Jerónimoca
dc.contributor.author Sáez-Navarro, Cristinaca
dc.contributor.author Bobes, Julioca
dc.contributor.author Baca-García, Enriqueca
dc.contributor.author Baca-García, Enriqueca
dc.contributor.author Olivares, José M.ca
dc.contributor.author Rodriguez-Jimenez, Robertoca
dc.contributor.author Villagrán, José M.ca
dc.contributor.author Gascón, Josepca
dc.contributor.author Cañete-Crespillo, Josepca
dc.contributor.author Solé, Montseca
dc.contributor.author Saiz, Pilar A.ca
dc.contributor.author Ibáñez, Ángelaca
dc.contributor.author Diego-Adeliño, Javier deca
dc.contributor.author AB-GEN Collaborative Groupca
dc.contributor.author Menchón, José M.ca
dc.date.accessioned 2018-04-19T09:20:46Z
dc.date.available 2018-04-19T09:20:46Z
dc.date.issued 2017
dc.description.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]). CONCLUSIONS: PGx-guided treatment resulted in significant improvement of MDD patient's response at 12 weeks, dependent on the number of previously failed medication trials, but not on sustained response during the study period. Burden of side effects was also significantly reduced.
dc.format.mimetype application/pdf
dc.identifier.citation Pérez V, Salavert A, Espadaler J, Tuson M, Saiz-Ruiz J, Sáez-Navarro C. et al. Efficacy of prospective pharmacogenetic testing in the treatment of major depressive disorder: results of a randomized, double-blind clinical trial. BMC Psychiatry. 2017 Jul 14;17(1):250. DOI: 10.1186/s12888-017-1412-1
dc.identifier.doi http://dx.doi.org/10.1186/s12888-017-1412-1
dc.identifier.issn 1471-244X
dc.identifier.uri http://hdl.handle.net/10230/34398
dc.language.iso eng
dc.publisher BioMed Centralca
dc.rights Copyright © The Author(s). 2017. Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated
dc.rights.accessRights info:eu-repo/semantics/openAccess
dc.rights.uri http://creativecommons.org/licenses/by/4.0/
dc.subject.keyword Antidepressant response
dc.subject.keyword Depression
dc.subject.keyword Pharmacogenetics
dc.subject.keyword Precision medicine
dc.subject.keyword Randomized clinical trial
dc.subject.other Depressió psíquica -- Tractament
dc.title Efficacy of prospective pharmacogenetic testing in the treatment of major depressive disorder: results of a randomized, double-blind clinical trialca
dc.type info:eu-repo/semantics/article
dc.type.version info:eu-repo/semantics/publishedVersion

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