Jeon, Hong Jin and Ju, Po-Chung and Sulaiman, Ahmad Hatim and Aziz, Salina Abdul and Paik, Jong-Woo and Tan, Wilson and Bai, Daisy and Li, Cheng-Ta (2022) 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. Clinical Psychopharmacology And Neuroscience, 20 (1). pp. 70-86. ISSN 1738-1088, DOI https://doi.org/10.9758/cpn.2022.20.1.70.
Full text not available from this repository.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 Patients with treatment-resistant depression received esketamine plus an oral antidepressant during the treatment period. Results: The incidence of >= 1 serious treatment-emergent adverse event (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.
| Item Type: | Article |
|---|---|
| Funders: | Janssen Asia Pacific, a division of Johnson and Johnson Pte Ltd. |
| Uncontrolled Keywords: | Administration; intranasal; Esketamine; Asia; Depressive disorder; treatment-resistant; Antidepressive agents |
| Subjects: | R Medicine > R Medicine (General) |
| Divisions: | Faculty of Medicine > Psychological Medicine Department |
| Depositing User: | Ms. Juhaida Abd Rahim |
| Date Deposited: | 22 Aug 2022 07:01 |
| Last Modified: | 22 Aug 2022 07:01 |
| URI: | http://eprints.um.edu.my/id/eprint/33415 |
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