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...
Journal of Psychiatric Research
June 1, 2026
Ludovic Samalin, Maud Rothärmel, Lila Mekaoui et al.
In patients with treatment-resistant depression (TRD), the efficacy and tolerance of intranasal esketamine (ESK) spray, alone or combined with oral antidepressants, has been supported by clinical trials and observational studies. The French real-world ESKALE study assessed the benefit of ESK in 157 patients with TRD. In this post-hoc analysis of the ESKALE study we aimed to describe the...
European Journal of Psychotraumatology
April 1, 2026
Maud Rothärmel, Lila Mekaoui, François Kazour et al.
1 citation
Background: Posttraumatic stress disorder (PTSD) is a severe and frequent affection that is highly comorbid to major depressive disorder. Comorbid PTSD and depression increase the risk of treatment-resistant depression (TRD), with a high risk of functional impairment and suicide. Esketamine nasal spray is a recent validated treatment for TRD, but its efficacy on comorbid TRD-PTSD 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...
Frontiers in Psychiatry
July 8, 2022
Maud Rothärmel, Cherifa Benosman, Wissam El-Hage et al.
31 citations
Introduction: Major depressive disorder (MDD) is more likely to resist to usual treatment when it is associated with post-traumatic stress disorder (PTSD). Capitalizing on the effect of ketamine in both treatment-resistant depression (TRD) and PTSD, we conducted a study in order to assess the efficacy of intranasal (IN) Esketamine in patients having TRD with comorbid PTSD. Materials and...