TY - JOUR
T1 - Esketamine nasal spray compassionate use program in the Netherlands
T2 - An open label, multi-center cohort study in severe treatment-resistant depression
AU - Busz, Abel (K A.J.).
AU - Schmidt, Emma (E J.).
AU - van den Brink, Rob (R H.S.).
AU - Foeken, Karen (K ).
AU - de Jong, Marasha (M ).
AU - Mertens, Joost (J B.C.).
AU - van Noorden, Martijn (M S.).
AU - Olivier, Etienne (E J.F.L.).
AU - Schruers, Koen (K R.J.).
AU - Schutters, Sara (S I.J.).
AU - van Son, Joris (J ).
AU - Strootker, Wessel (W J.).
AU - Venema, Harry (H C.P.).
AU - de Waardt, Dieuwertje (D A.).
AU - Zantvoord, Jasper (J B.).
AU - Cath, Danielle (D ).
AU - Ruhe, Henricus (H G.).
N1 - Funding Information:
We thank everyone, researchers, healthcare providers and patients, who participated in this study by starting treatment centers, gathering data, providing data, undergoing treatment and the founding of \u2018Esketamine Nasal spray Consortium Nederland\u2019 (ENC-NL), for exchanging experiences and conducting scientific research.
Publisher Copyright:
© 2025
PY - 2025/4
Y1 - 2025/4
N2 - Background: Esketamine, a N-methyl-D-aspartate (NMDA) receptor antagonist, used intranasally (IN), is applied as an antidepressant (AD) in treatment-resistant depressed (TRD) patients. Real-world studies with IN esketamine are still scarce. Objectives: To evaluate the effectiveness and potential moderators of response of IN esketamine in real-world TRD patients treated in a compassionate use program (CUP) in the Netherlands. Method: In this multi-center, open label, naturalistic cohort-study 42 patients were treated with 28–84 mg IN esketamine augmenting an oral AD. We used the Montgomery-Asberg rating scale (MADRS) change scores as primary outcome and report response-, remission rates and minimal clinically important difference (MCID) reached after 28 and 90 days of treatment. Potential effect moderators studied were level of treatment resistance and history of electroconvulsive therapy (ECT). Results: Baseline mean MADRS score was 33.6 ± 5.3 and 64.3 % of the population had a history of ≥5 failed AD treatments. At 28 days, a significant decrease of 10.1 (7.3–12.6) MADRS-points was observed (Cohen's d 1.9, 95 % CI: 0.26–0.45, t = 7.20, p < .001). Between 29 and 90 days no additional significant decrease in the MADRS score was observed. Response- and remission rates were 28.6 % and 14.3 % at 28 days and 35.7 % and 19.8 % at 90 days (n = 42), respectively. At 28 days 52.4 % achieved MCID. No clinically relevant moderating effects were found. Limitations: Small sample size and variable time between screening and start of treatment. Conclusions: In this group of TRD patients, IN esketamine treatment showed significant effectiveness, suggesting a valuable treatment option for this group.
AB - Background: Esketamine, a N-methyl-D-aspartate (NMDA) receptor antagonist, used intranasally (IN), is applied as an antidepressant (AD) in treatment-resistant depressed (TRD) patients. Real-world studies with IN esketamine are still scarce. Objectives: To evaluate the effectiveness and potential moderators of response of IN esketamine in real-world TRD patients treated in a compassionate use program (CUP) in the Netherlands. Method: In this multi-center, open label, naturalistic cohort-study 42 patients were treated with 28–84 mg IN esketamine augmenting an oral AD. We used the Montgomery-Asberg rating scale (MADRS) change scores as primary outcome and report response-, remission rates and minimal clinically important difference (MCID) reached after 28 and 90 days of treatment. Potential effect moderators studied were level of treatment resistance and history of electroconvulsive therapy (ECT). Results: Baseline mean MADRS score was 33.6 ± 5.3 and 64.3 % of the population had a history of ≥5 failed AD treatments. At 28 days, a significant decrease of 10.1 (7.3–12.6) MADRS-points was observed (Cohen's d 1.9, 95 % CI: 0.26–0.45, t = 7.20, p < .001). Between 29 and 90 days no additional significant decrease in the MADRS score was observed. Response- and remission rates were 28.6 % and 14.3 % at 28 days and 35.7 % and 19.8 % at 90 days (n = 42), respectively. At 28 days 52.4 % achieved MCID. No clinically relevant moderating effects were found. Limitations: Small sample size and variable time between screening and start of treatment. Conclusions: In this group of TRD patients, IN esketamine treatment showed significant effectiveness, suggesting a valuable treatment option for this group.
KW - Cohort study
KW - Compassionate use
KW - Depression
KW - Intranasal esketamine
KW - Real-world data
KW - Treatment-resistant depression
U2 - 10.1016/j.jadr.2025.100905
DO - 10.1016/j.jadr.2025.100905
M3 - Article
SN - 2666-9153
VL - 20
JO - Journal of Affective Disorders Reports
JF - Journal of Affective Disorders Reports
M1 - 100905
ER -