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

This prospective, multicenter, randomized, double-blind, naturalistic clinical study was approved by the Institutional Review Board (IRB) of Hospital Clínic de Barcelona (Spain), acting as a centralized reference IRB, as well as the IRB of each participating hospital (see ‘List of Ethic Committees’ in the Additional file 2). The study was conducted in compliance with Good Clinical Practice requirements and the Declaration of Helsinki. Written informed consent was obtained from all participants before enrolment.

Not applicable.

Competing interests

VP has received grants and served as consultant, advisor or CME speaker for AB-Biotics, AstraZeneca, Bristol-Myers Squibb, Glaxo-Smith-Kline, Pfizer, Janssen, Lundbeck, Medtronic, Otsuka, and the Spanish Ministry of Economy and Competitiveness (Centro de Investigación Biomédica en Red de Salud Mental, CIBERSAM). AS and JE are employees of and minor stock shareholders in AB-Biotics. MT is employee of AB-Biotics. JSR has received grants and served as consultant, advisor or CME speaker for Lundbeck, Janssen and Otsuka. JB1 has received grants and served as consultant, advisor or CME speaker for AB-Biotics, Adamed, Almirall, AstraZeneca, Bristol-Myers Squibb, Ferrer, Glaxo-Smith-Kline, Hoffman-La Roche, Janssen-Cilag, Eli Lilly, Lundbeck, Merck, Novartis, Organon, Otsuka, Pfizer, Pierre-Fabre, Sanofi-Aventis, Servier, Schering-Plough and Shire, and research funding from the Spanish Ministry of Economy and Competitiveness (CIBERSAM, Instituto de Salud Carlos III, ISCIII), Spanish Ministry of Health, Social Services and Equality (Plan Nacional sobre Drogas) and the European Union’s 7th Framework Program (EU FP7). EB has received grants from Janssen, Otsuka and Servier. EV has received grants and served as consultant, advisor or CME speaker for AB-Biotics, Actavis, Allergan, AstraZeneca, Bial, Bristol-Myers Squibb, Dainippon Sumitomo Pharma, Elan, Eli Lilly, Farmindustria, Ferrer, Forest Research Institute, Gedeon Richter, Glaxo-Smith-Kline, Janssen, Lundbeck, Otsuka, Pfizer, Roche, Sanofi-Aventis, Servier, Shire, Solvay, Sunovion, Takeda, Telefonica, the Brain & Behavior Research Foundation (NARSAD), CIBERSAM, the EU FP7 (ENBREC), and the Stanley Medical Research Institute. JMO has received grants and served as consultant, advisor or CME speaker for AstraZeneca, Bristol-Myers Squibb, Glaxo-Smith-Kline, Pfizer, Janssen, Lundbeck, Otsuka, Eli Lilly, Novartis, and Sanofi-Aventis. RRJ has received grants and served as consultant, advisor or CME speaker for ISCIII, Fondo de Investigación Sanitaria (FIS), CIBERSAM, Madrid Regional Government (S2010/BMD-2422 AGES), Janssen-Cilag, Lundbeck, Otsuka, Pfizer, Ferrer, Juste. JMV has received grants and served as consultant, advisor or CME speaker for Janssen-Cilag, Pfizer, Bristol-Myers Squibb, Otsuka, Glaxo-Smith-Kline, AstraZeneca, Sanofi-Aventis, Novartis, Lundbeck and Ferrer. JG has received grants and served as consultant, advisor or CME speaker for Janssen-Cilag, Lundbeck, Pfizer and BioClever 2005. JCC has received grants and served as consultant for Lundbeck/Otsuka. PAS has received grants or served as consultant for Adamed, AstraZeneca, Brainpharma, Bristol-Myers Squibb, Esteve, Ferrer inCode, Glaxo-Smith-Kline, Janssen-Cilag, Eli Lilly, Lundbeck, Otsuka, Pfizer, Rovi, Servier, the Spanish Ministry of Health, Social Services and Equality (Plan Nacional sobre Drogas), CIBERSAM, and the EU FP7. AI has served as speaker or advisor for Bristol-Myers Squibb, Ferrer, Lundbeck, Otsuka and Servier. JDA is funded by the Instituto de Salud Carlos III through a ‘Juan Rodés’ research fellowship (JR14/00011) and has received lecture honoraria from Pfizer, Glaxo-Smith-Kine and Lundbeck. JMM1 has received grants and served as consultant, advisor or CME speaker for AB-Biotics, Ferrer, Glaxo-Smith-Kline, Janssen, Lundbeck, Medtronic, Otsuka, and CIBERSAM. EA1 has received grants and served as consultant, advisor or CME speaker for AB-Biotics, Eli Lilly, Lundbeck, Pfizer, Sanofi-Aventis, Bristol-Myers Squibb, Servier and Otsuka. FMC has served as consultant for Janssen-Cilag. JQ has received grants, served as consultant or CME speaker for Janssen, Otsuka, Shire, Mutua Madrileña & Grunethal. DJP has received grants and served as consultant for Lundbeck/Otsuka. MG has received grants and served as consultant, advisor or CME speaker for Ferrer, Janssen, Lundbeck and the Spanish Ministry of Economy and Competitiveness (ISCIII). VS has received grants and served as consultant or CME speaker for Servier, Rovi, Lundbeck, Pfizer and the Spanish Ministry of Science and Innovation. CDA has received grants and served as consultant, advisor or CME speaker for Lundbeck, Rovi, Eli Lilly and Pfizer. JMM2 has received grants and served as CME speaker for Janssen-Cilag, Pfizer, Otsuka, AstraZeneca, Sanofi-Aventis, Lundbeck and Ferrer. FM has received grants and served as consultant, advisor or CME speaker for AstraZeneca, Ferrer, Janssen, Glaxo-Smith-Kline, Pfizer, Otsuka and Lundbeck. PMH has received grants and served as consultant, advisor or CME speaker for Janssen-Cilag, Lundbeck, Otsuka, Boehringer Ingelheim. EA2 has received grants and served as CME speaker for Janssen-Cilag and Otsuka. MPGP has received grants or served as consultant for Lundbeck/Otsuka, ISCIII, CIBERSAM, Janssen-Cilag, Eli Lilly, Lundbeck, Otsuka, Pfizer, Servier, Roche and Rovi. MB has received grants and served as consultant, advisor or CME speaker for AB-Biotics, Adamed, Almirall, Amgen, Boehringer, Eli Lilly, Ferrer, Forum Pharmaceuticals, Gedeon Richter, Hersill, Janssen-Cilag, Lundbeck, Otsuka, Pfizer, Roche, Servier and has obtained research funding from the Ministry of Education, Culture and Sports, ISCIII, CIBERSAM, the Government of Catalonia, Secretaria d’Universitats i Recerca del Departament d’Economia i Coneixement (2014SGR441), European Group for Research In Schizophrenia (EGRIS) Foundation, and the EU FP7. MP and NR are employees of AB-Biotics. MAB is employee of and stock shareholder in AB-Biotics. All other authors declare no conflicts of interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.