Efficacy of prospective pharmacogenetic testing in the treatment of major depressive disorder: Results of a randomized, double-blind clinical trial
AuthorPérez, Víctor; Salavert, Ariana; Espadaler, Jordi; Tuson, Miquel; Saiz-Ruiz, Jerónimo; Sáez-Navarro, Cristina; Bobes, Julio; Baca-García, Enrique; Vieta, Eduard; Olivares, José M.; Rodriguez-Jiménez, 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.
EntityUAM. Departamento de Psiquiatría; Instituto de Investigación Sanitaria Fundación Jiménez Díaz (IIS-FJD)
PublisherBioMed Central Ltd.
10.1186/s12888-017-1412-1BMC Psychiatry 17.1 (2017): 250-1
Funded byThis work was supported by the Spanish Centre for Industrial Technological Development (Centro para el Desarrollo Tecnológico Industrial, CDTI; IDI-20130958) and the Spanish Ministry of Economy and Competitiveness PTQ-11-05076; PTQ- 11-04914; INC-FPGS-2011-2223; INC-FPGS-2011-2224. The funding agency had no role in the development of the study design, collection of data, manuscript development, or the decision to submit this manuscript for publication. The study also received funding support from private investors (Mr. Luis Sánchez-Lafuente and Mr. Sergi Audivert) as well as from Almirall SA (Barcelona, Spain). AB-Biotics as sponsor participated in the design, analysis and interpretation of the study
ProjectGobierno de España. IDI-20130958; Gobierno de España. PTQ-11-05076; Gobierno de España. PTQ- 11-04914; Gobierno de España. INC-FPGS-2011-2223; Gobierno de España. INC-FPGS-2011-2224
SubjectsDepression; Pharmacogenetics; Precision medicine; Antidepressant response; Randomized clinical trial; Medicina
Rights© The Author(s). 2017
Esta obra está bajo una Licencia Creative Commons Atribución 4.0 Internacional.
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.
Google Scholar:Pérez, Víctor - Salavert, Ariana - Espadaler, Jordi - Tuson, Miquel - Saiz-Ruiz, Jerónimo - Sáez-Navarro, Cristina - Bobes, Julio - Baca-García, Enrique - Vieta, Eduard - Olivares, José M. - Rodriguez-Jiménez, 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.
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