Effects of esketamine on patient-reported outcomes in major depressive disorder with active suicidal ideation and intent: a pooled analysis of two randomized phase 3 trials (ASPIRE I and ASPIRE II).

"Declarations Conflict of interestH. Rozjabek, D-J. Fu, D. F. Ionescu, R. Lane, C. M. Canuso, X. Qiu and C. Jamieson are employees of Janssen Research & Development, LLC and may own stock or stock options. P. Molero is supported by Clinica Universidad de Navarra and has received research grants from the Ministry of Education (Spain), the Government of Navarra (Spain) and the Spanish Foundation of Psychiatry and Mental Health and AstraZeneca; he is a clinical consultant for MedAvante-ProPhase and has received lecture honoraria from and/or has been a consultant for AB-Biotics, Adept Field Solutions, Guidepoint, Janssen, Novumed, Roland Berger and Scienta. From 2015, PM has been the principal investigator at Clinica Universidad de Navarra of several studies supported by Janssen about the efficacy and safety of esketamine for Major depressive disorder. Ethical approvalThe protocol and amendments were approved by local independent ethics committees/Institutional Review Boards. Research involving human and animal participantsAll procedures performed in studies involving human participants were in accordance with the International Council for Harmonization Good Clinical Practice Consolidated Guideline, the applicable local laws and regulatory requirements of the countries in which the trial was conducted, and with the principles of the Declaration of Helsinki. The findings of this study were reported in accordance with the CONSORT PRO guidelines for reporting patient-reported outcomes in randomized-controlled trials Consent to participateWritten informed consent was obtained from all participants before enrollment in the trial. Conflict of interest H. Rozjabek, D-J. Fu, D. F. Ionescu, R. Lane, C. M. Canuso, X. Qiu and C. Jamieson are employees of Janssen Research & Development, LLC and may own stock or stock options. P. Molero is supported by Clinica Universidad de Navarra and has received research grants from the Ministry of Education (Spain), the Government of Navarra (Spain) and the Spanish Foundation of Psychiatry and Mental Health and AstraZeneca; he is a clinical consultant for MedAvante-ProPhase and has received lecture honoraria from and/or has been a consultant for AB-Biotics, Adept Field Solutions, Guidepoint, Janssen, Novumed, Roland Berger and Scienta. From 2015, PM has been the principal investigator at Clinica Universidad de Navarra of several studies supported by Janssen about the efficacy and safety of esketamine for Major depressive disorder."

"Funding The studies presented in this report were supported by Janssen Research & Development, LLC."

"Trial registration : ClinicalTrials.gov Identifier: ASPIRE I, NCT03039192 (Registration date: February 1, 2017); ASPIRE II, NCT03097133 (Registration date: March 31, 2017)."