Clinical Psychopharmacology and Neuroscience Papers in Press available online.

 
Long-term safety and efficacy of esketamine nasal spray plus an oral antidepressant in patients with treatment-resistant depression – an Asian sub-group analysis from the SUSTAIN-2 study.
Hong Jin Jeon 1,2,3, Po-Chung Ju 4,5, Ahmad Hatim Sulaiman 6, Salina Abdul Azis 7, Jong-Woo Paik 8, Wilson Tan 9,*, Daisy Bai 10, Cheng-Ta Li 11,12
1Department of Psychiatry, Depression Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea, 2Korea Psychological Autopsy Center (KPAC), Seoul, Korea, 3Samsung Advanced Institute for Health Sciences & Technology (SAIHST), Seoul, Korea, 4Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan, 5Department of Psychiatry, Chung Shan Medical University Hospital, Taichung, Taiwan, 6Department of Psychological Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia, 7Department of Psychiatry and Mental Health, Hospital Kuala Lumpur. Kuala Lumpur, Malaysia, 8Department of Psychiatry, Kyung Hee University College of Medicine, Seoul, Korea, Seoul, Korea, 9Regional Medical Affairs, Janssen Pharmaceutical Companies of Johnson and Johnson, Singapore, 10Statistics & Decision Sciences, Janssen Research & Development, LLC, Shanghai, China., 11Division of Community & Rehabilitation Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan, 12Functional Neuroimaging and Brain Stimulation Lab, National Yang-Ming University, Taipei, Taiwan
Abstract
Objective: To evaluate the long-term safety and efficacy of intranasal esketamine in patients with treatment-resistant depression from the Asian subgroup of the SUSTAIN-2 study.
Methods: SUSTAIN-2 was a phase 3, open-label, single-arm, multicenter study comprising a 4-week screening, 4-week induction, 48-week optimization/maintenance, and 4-week follow-up (upon esketamine discontinuation) phase. TRD patients received esketamine plus an oral antidepressant during the treatment period.
Results: The incidence of ≥1 serious treatment-emergent adverse events (TEAE) among the 78 subjects from the Asian subgroup (Taiwan: 33, Korea: 26, Malaysia: 19) was 11.5% (n=9); with no fatal TEAE. 13 Asian patients (16.7%) discontinued esketamine due to TEAEs. The most common TEAEs were dizziness (37.2%), nausea (29.5%), dissociation (28.2), and headache (21.8%). Most TEAEs were mild to moderate in severity, transient and resolved on the same day. Upon discontinuation of esketamine, no trend in withdrawal symptoms was observed to associate long-term use of esketamine with withdrawal syndrome. There were no reports of drug seeking, abuse, or overdose. Improvements in symptoms, functioning and quality of life, occurred during in the induction phase and were generally maintained through the optimization/maintenance phases of the study.
Conclusion: The safety and efficacy of esketamine in the Asian subgroup was generally consistent with the total SUSTAIN-2 population. There was no new safety signal and no indication of a high potential for abuse with the long-term (up to one year) use of esketamine in the Asian subgroup. Most of the benefits of esketamine occurred early during the induction phase.
Accepted Manuscript [Submitted on 2021-01-05, Accepted on 2021-03-26]