Facts and myths about use of esketamine for treatment-resistant depression: a narrative clinical review

Di Vincenzo, Matteo; Martiadis, Vassilis; Della Rocca, Bianca; Arsenio, Eleonora; D’Arpa, Andrea; Volpicelli, Antonio; Luciano, Mario; Sampogna, Gaia; Fiorillo, Andrea

doi:10.3389/fpsyt.2024.1394787

Cited by 2 publications

(1 citation statement)

References 107 publications

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“…Esketamine, in the form of an intranasal spray, was first approved for the treatment of treatment-resistant unipolar depression by EMA in December 2019 ( 75 ). Additionally, common misconceptions about safety and tolerability of ketamine and esketamine have recently been refuted ( 76 ). Therefore, we expect that the use of ketamine and esketamine will very likely increase in the near future.…”

Section: Discussionmentioning

confidence: 99%

Treatment of bipolar depression: clinical practice vs. adherence to guidelines—data from a Bavarian drug surveillance project

Kriner,

Brieger,

Pogarell

et al. 2024

Front. Psychiatry

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ObjectivesPharmacotherapy of bipolar depression (BPD) is confronted with major clinical challenges, like limited evidence-based treatment options, regular cases of treatment resistance, and risk of treatment-emergent affective switches. Medical guidelines can support practitioners to make decisions based on current scientific evidence. The objective of this study is to evaluate to what extent recommendations of the 2019 German S3 guidelines “Diagnosis and Treatment of Bipolar Disorders” are reflected in clinical practice in inpatient treatment.MethodsWe conducted a descriptive analysis of prescription numbers in 2,627 patients with BPD in a naturalistic inpatient setting analyzing data from the ongoing Bavarian multicenter drug safety project Pharmaco-Epidemiology and Vigilance (Pharmako-EpiVig) from the years 2014–2022.ResultsOf the patients, 38% were not administered any drug explicitly recommended for treatment of BPD, that is, quetiapine, lamotrigine, carbamazepine, or olanzapine. Only 6% of the patients received monotherapy with one of those drugs. Of the patients, 34% were administered ≥4 psychotropic drugs simultaneously. Patients received 912 different therapy regimens of mono or combination therapy with mood stabilizers (MS), atypical antipsychotics (AAP), and antidepressants. Of the patients, 72% received an antidepressant and 6% without concomitant prescription of an AAP or MS. Prescription rates of venlafaxine (21% to 14%) and tricyclic antidepressants (9% to 6%) decreased significantly from the first (2014–2016) to the last (2020–2022) observed time period. Of the patients, 60% received an MS. Prescription rate of valproate (22% to 14%) decreased significantly, while lithium prescription increased significantly (29% to 35%). Of the patients, 71% were administered an AAP. Quetiapine was the most prescribed drug overall (43%). Only two patients were administered a combination of olanzapine and fluoxetine.ConclusionOur results demonstrate a substantial gap between guideline recommendations and current clinical practice. The remarkable heterogeneity in treatment regimens, with no discernible dominant treatment approach, is in part a reflection of the complexity of bipolar disorder but also substantiates the need of comprehensive recommendations regarding combination therapies. Increase in lithium prescription is an encouraging development due to its unique efficacy in maintenance treatment. To improve the quality of clinical practice guideline implementation, more randomized controlled trials should be conducted in the future to prospectively investigate different implementation strategies.

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Section: Discussionmentioning

confidence: 99%

Treatment of bipolar depression: clinical practice vs. adherence to guidelines—data from a Bavarian drug surveillance project

Kriner,

Brieger,

Pogarell

et al. 2024

Front. Psychiatry

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Use of Esketamine Nasal Spray in Patients with Treatment‐Resistant Depression in Routine Practice: A Real‐World French Study

Samalin,

Mekaoui,

Rothärmel

et al. 2024

Depression and Anxiety

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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.

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Facts and myths about use of esketamine for treatment-resistant depression: a narrative clinical review

Cited by 2 publications

References 107 publications

Treatment of bipolar depression: clinical practice vs. adherence to guidelines—data from a Bavarian drug surveillance project

Treatment of bipolar depression: clinical practice vs. adherence to guidelines—data from a Bavarian drug surveillance project

Use of Esketamine Nasal Spray in Patients with Treatment‐Resistant Depression in Routine Practice: A Real‐World French Study

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