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Background. 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. Materials and Methods. This study used secondary data from patient files of hospital‐based psychiatrists and started during the first French patient early access to ESK. The response and remission rates with ESK were analyzed using the total score of the Montgomery–Åsberg Depression Rating Scale (MADRS). The time to first treatment response and work resumption were described (Kaplan–Meier method). Adverse events (AEs) were analyzed. Results. Prior to ESK initiation, the 157 analyzed patients (age ≤ 65 years, 82.8%; female, 66.2%) had depression for 10.5 years (median, IQR, 4.2–21.2) and received a median of 6 (3–8) previous treatment lines. At ESK initiation, the mean ± SD total MADRS score was 32.1 ± 7.7. At that time, ESK was combined with antidepressants (93.6% of patients; SNRI, 65.0%; SSRI, 57.3%) and/or other potentiation strategy (63.1%; atypical antipsychotics, 36.3%; lithium, 25.6%; antiepileptics, 21.7%). During the 12‐month follow‐up, 125 patients (79.6%) discontinued ESK. The median duration of ESK treatment was 19.4 weeks (IQR, 4.4–40.1). At 1 month after ESK initiation, 40.2% of still treated patients met criteria for clinical response and 19.7% for remission (median time to response, 5.7 weeks; 95% CI (4.1–8.4)). 82.6% of active patients were on sick leave at ESK initiation; the work resumption rate was 24% (13%–40%) 12 weeks later. AEs were reported in 68.6% of patients, serious AEs in 17.2%, and AEs leading to ESK discontinuation in 14.6%. Conclusion. These real‐world effectiveness and safety data were consistent with findings from previous clinical trials, describing the real‐life clinical experience of patients receiving ESK and confirming that ESK has its place in therapy for the treatment of TRD. [ABSTRACT FROM AUTHOR]

Objective: 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. Methods: Data were collected from medical records and included patient characteristics, disease history at esketamine initiation, use of neurostimulation, the patient's care pathway, and the number of antidepressant treatment lines prescribed prior to esketamine initiation. Descriptive statistics were used for each cohort: the early access program 'Temporary Authorisation for Use' (ATU), post-ATU, and post-launch cohorts. Results: The overall ESKALE cohort (N = 160 included; n = 157 treated with esketamine; average age 49.0 years; 66.2% female) demonstrated moderate-to-severe depression according to clinical assessment and a mean Montgomery-Åsberg Depression Rating Scale score of 32.6 (8.0); however, severity, subtype, and comorbidities were heterogeneous across the cohorts. Earlier use of esketamine and prior to alternative treatments occurred during the later cohorts. Conclusion: These findings demonstrated a high burden of TRD in these patients and that esketamine is used in TRD treatment regardless of their disease severity, subtype, or existing comorbidities. These results also suggest that esketamine is potentially a clinically useful alternative treatment, particularly with healthcare professionals gaining greater familiarity with and easier access to esketamine. KEY POINTS: ESKALE is a long-term, French, multicentre, observational study based on secondary data in adult patients with treatment-resistant depression (TRD) who initiated esketamine treatment in one of three mutually exclusive cohorts: the Temporary Authorisation for Use (ATU), post-ATU, and post-launch cohorts. ESKALE is one of the largest European real-world studies investigating the profiles of more than 150 patients and their treatment with esketamine before and after marketing authorisation. A majority of patients had moderate to severe TRD, with multiple treatment failures with medications and/or neurostimulation prior to esketamine initiation. Esketamine nasal spray administration was undertaken more frequently in an outpatient setting, with the post-administration period monitoring being undertaken mostly by nurses. Esketamine was used in patients with TRD in real-world conditions regardless of their disease severity and subtype or existing comorbidities. These results highlight both the need for an effective treatment for TRD and the adoption of esketamine by multidisciplinary teams that are involved in esketamine prescription and administration. [ABSTRACT FROM AUTHOR]

Depression is a common and debilitating pathology with a significant socioeconomic impact. Early and optimal treatment can help to reduce its progression towards chronicity and long-term cognitive disorders. In the context of falling numbers of medical professionals and the poor provision of validated tools, such as cognitive behavioural therapy, the use of eHealth in depression presents a clear benefit in terms of diagnostic efficacy, patient autonomy, prevention of relapse and health care costs. Innovation must however be associated with ethical deliberation, which respects the patients and their needs., (Copyright © 2017 Elsevier Masson SAS. All rights reserved.)

Approximately 80% of the patients who have a first episode of major depression will have at least one more. The lifetime average is 4 episodes. Nevertheless, despite this high risk of relapse, often severe and disabling, only half the patients with recurrent major depression receive prophylactic treatment. Long-term antidepressant treatment appears to be the most effective option for prophylactic treatment of recurrent major depression. The optimal duration of this treatment remains uncertain, in part because of the lack of long-term studies, that is, with a follow-up longer than 2 years. The interpretation of some of the controlled studies of the prophylactic efficacy of antidepressant treatment is limited by methodological issues: most antidepressants have not been studied in a purely prophylactic approach, but rather as a maintenance treatment after response during an acute episode. Lithium and carbamazepine may be prescribed as second-line preventive treatment. Although we lack controlled studies of the prophylactic efficacy of psychotherapies in recurrent depression, interpersonal, cognitive and behavioral psychotherapies have been shown to be effective in reducing the relapse rate, especially when associated with antidepressants. Treatment duration should be determined individually, taking into account the patient's risk profile and international and national guidelines.