Therapeutic Advances in Psychopharmacology
August 1, 2026
Pierre-Michel Llorca, Anne Sauvaget, Emilie Olié et al.
Background: Major depressive disorder (MDD) is highly prevalent and associated with significant disability and mortality. Treatment-resistant depression (TRD), defined as inadequate response to ⩾2 antidepressant lines, remains a major therapeutic challenge. Esketamine nasal spray, approved in 2019 for TRD, demonstrated efficacy and safety in randomized trials, but real-world evidence remains...
International Journal of Psychiatry in Clinical Practice
June 1, 2024
Ludovic Samalin, Lila Mekaoui, Pierre De Maricourt et al.
3 citations
ESKALE is a French, multicentre, observational study of adults with treatment-resistant depression (TRD) treated with esketamine. This interim analysis describes baseline demographic and clinical characteristic evolution in patients included and treated from early access program to post-marketing launch. Data were collected from medical records and included patient characteristics, disease...
Depression and Anxiety
2024
Ludovic Samalin, Lila Mekaoui, Maud Rothärmel et al.
16 citations
The efficacy and safety of esketamine nasal spray (ESK) were established in registration trials in patients with treatment-resistant depression (TRD). This French real-world study aimed to describe the treatment patterns, effectiveness, and safety of ESK in TRD patients over a 12-month follow-up. This study used secondary data from patient files of hospital-based psychiatrists and started...
European Psychiatry
November 17, 2023
Émeline Gaudré-Wattinne, Lila Mekaoui, Maud Rothärmel et al.
1 citation
Introduction Esketamine nasal spray has been developed for patients with treatment resistant depression. Objectives A cohort Temporary Authorization for Use (ATUc) allowed to collect for a 6-month period the first data in real life Methods On 02/08/2019 the French National Agency for Medicines and Health Product Safety granted an early access program for Esketamine nasal spray framed by a...
International Journal of Psychiatry in Clinical Practice
November 2022
Ludovic Samalin, Maud Rothärmel, Lila Mekaoui et al.
To present the first real-world data of patients with treatment-resistant depression (TRD) treated with esketamine through a French cohort Temporary Authorisation for Use (ATUc) programme. In 2019, the French Health Authorities exceptionally granted the first ATUc in psychiatry for TRD patients. Clinical characteristics, safety and efficacy data were reported by physicians. The ATUc ended ∼6...