Our new registered report "Efficacy and safety of esketamine for “treatment resistant depression”: registered report for a Systematic Review with an Individual Patient Data Meta-analysis of Randomized, Double-Blind, Placebo-Controlled Trials" has just received in principle acceptance at BMC Medicine.
In 2019, the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved a nasal spray formulation of esketamine for “treatment resistant depression” (TRD). However, the evidence base for its use proved to be controversial. This registered report aims to independently reappraise the efficacy of esketamine in TRD, by i) exploring the possibility of data integrity issues, ii) re-analyzing and iii) pooling the trial data. Main secondary objectives are to reappraise the safety of esketamine in the treatment of TRD and to explore whether esketamine’s efficacy and safety vary with level of treatment resistance and patient age.
Considering the increased sales of esketamine and the growing interest of patients and clinicians in the drug, this review addresses a highly relevant topic. This project is funded by the “Programme Hospitalier de Recherche Clinique” from the French Ministry of Health [Esketamine for “treatment resistant depression”: an Individual Patient Data Meta-analysis: ESK-T-Dep]. The funder has no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
This project will be performed by an international group (Florian Naudet, Claude Pellen, Liviu A Fodor, Chiara Gastaldon, Corrado Barbui, Erick H Turner and Ioana A Cristea.
The protocol is now registered here... https://osf.io/xetvn
More news soon, we will try to update important step of the project on the blog.