Psychiatrie clinique, biologique et thérapeutique

Long-term Safety of Esketamine : Interim Results of the SUSTAIN-3 Study

Publié le mardi 15 mars 2022




  1. Janssen Research & Development, Titusville, Nj, Etats-Unis
  2. Janssen Scientific Affairs, Titusville, Nj, Etats-Unis
  3. Janssen Research & Development, Pennington, Nj, Etats-Unis
  4. Yale University School of Medicine, New Haven, Ct,, Etats-Unis
  5. Janssen Research and Development, Beerse, Belgique


Esketamine nasal spray (ESK) plus a newly initiated oral antidepressant (AD) has demonstrated robust efficacy and an acceptable safety profile in managing treatment-resistant depression (TRD). However, long-term (>1 year) safety data are limited.


This ongoing phase 3, open-label extension study is being conducted to evaluate the long-term safety (and efficacy) of individualized, intermittently-dosed ESK in conjunction with an oral AD in patients with TRD. Patients (≥18 years) who previously participated in 1 of 6 phase 3, “parent” studies of ESK entered either the 4-week induction (IND) phase or the long-term optimization/maintenance (OP/M) phase of this study based on their status at the end of the parent study. Safety evaluations included treatment-emergent adverse events (TEAEs), and cognition. Interim safety results from the extension study are reported herein.


A total of 1148 patients (458 entered at IND; 690 entered at OP/M) were enrolled in the study. Of 458 patients who entered the IND phase, 420 (91.7%) continued to OP/M phase. Of 1110 patients who participated in the OP/M phase, 306 (27.6%) discontinued the study, primarily due to AEs (n=54), lack of efficacy (n=48), and other reasons (n=135; e.g., symptom improvement, scheduling/logistical conflicts, etc.). The median total duration of exposure, including exposure in the preceding parent study, was approximately 3 years (35.8 [range: 0, 57] months). In total, 1064 patients experienced ≥1 TEAEs (IND: 346/458, 75.5%; OP/M: 1024/1110, 92.3%). The most common TEAEs (≥10% of patients) in IND phase were dissociation (21.2%), dizziness (20.5%), nausea (17.7%), vertigo (16.8%),  dysgeusia (bad/altered taste) (16.6%), and headache (15.1%) and in OP/M phase were headache (31.2%), dizziness (29.8%), nausea (28.1%), dissociation (22.3%), somnolence (21.8%), nasopharyngitis (21.5%), dysgeusia (18.6%), vertigo (16.8%), anxiety (14.4%), back pain (14.3%), vomiting (13.6%), diarrhea (12.3%), increased blood pressure, urinary tract infection (each 12.1%), upper respiratory tract infection (11.3%), and blurred vision (10.1%). Most TEAEs were mild or moderate in severity. Long-term exposure to ESK did not reveal any additional safety signals of concern related to bladder-, lower urinary tract-, or hepatic-related TEAEs. There were 4 (0.3%) deaths, none considered by the investigator as related to ESK. Cognition remained stable or showed trend for small improvement among all patients during the IND and OP/M phases, with the exception of a slight slowing of reaction times in patients aged ≥65 years, consistent with results of another longitudinal trial.


This interim analysis suggests that long-term treatment (~3 years) with ESK+AD  has acceptable safety and tolerability. No new or unexpected safety concerns emerged during 3-year intermittently-dosed treatment with ESK. 


Consulter le poster

Retour aux meilleurs posters 2022

Dernières actualités

Inégalités et apprentissages chez l'enfant

Un grand sujet revisité par les orateurs de cette conférence ! Écoutez-les si vous voulez rafraîc...

Régulateurs de l'humeur, quoi de neuf ?

Un grand sujet revisité par les orateurs de cette conférence ! Écoutez-les si vous voulez rafraîc...

Les syndromes (jamais) oubliés en psychiatrie

Parfois construits dès la fin du 19e siècle, certains des grands syndromes de la psychiatrie ont...

Le futur des psychotropes, un oxymore ?

Suivez cette conférence pour faire le point sur les travaux en cours dans la recherche sur les ps...