Wajs, Ewa and Aluisio, Leah and Holder, Richard and Daly, Ella J. and Lane, Rosanne and Lim, Pilar and George, Joyce E. and Morrison, Randall L. and Sanacora, Gerard and Young, Allan H. and Kasper, Siegfried and Sulaiman, Ahmad Hatim and Li, Cheng Ta and Paik, Jong Woo and Manji, Husseini and Hough, David and Grunfeld, Jennifer and Jeon, Hong Jin and Wilkinson, Samuel T. and Drevets, Wayne C. and Singh, Jaskaran B. (2020) Esketamine Nasal Spray Plus Oral Antidepressant in Patients With Treatment-Resistant Depression. The Journal of Clinical Psychiatry, 81 (3). 19m12891. ISSN 0160-6689, DOI https://doi.org/10.4088/JCP.19m12891.
Full text not available from this repository.Abstract
OBJECTIVE: To evaluate long-term safety and efficacy of esketamine nasal spray plus a new oral antidepressant (OAD) in patients with treatment-resistant depression (TRD). METHODS: This phase 3, open-label, multicenter, long-term (up to 1 year) study was conducted between October 2015 and October 2017. Patients (≥ 18 years) with TRD (DSM-5 diagnosis of major depressive disorder and nonresponse to ≥ 2 OAD treatments) were enrolled directly or transferred from a short-term study (patients aged ≥ 65 years). Esketamine nasal spray (28-mg, 56-mg, or 84-mg) plus new OAD was administered twice a week in a 4-week induction (IND) phase and weekly or every-other-week for patients who were responders and entered a 48-week optimization/maintenance (OP/MAINT) phase. RESULTS: Of 802 enrolled patients, 86.2% were direct-entry and 13.8% were transferred-entry; 580 (74.5%) of 779 patients who entered the IND phase completed the phase, and 150 (24.9%) of 603 who entered the OP/MAINT phase completed the phase. Common treatment-emergent adverse events (TEAEs) were dizziness (32.9%), dissociation (27.6%), nausea (25.1%), and headache (24.9%). Seventy-six patients (9.5%) discontinued esketamine due to TEAEs. Fifty-five patients (6.9%) experienced serious TEAEs. Most TEAEs occurred on dosing days, were mild or moderate in severity, and resolved on the same day. Two deaths were reported; neither was considered related to esketamine. Cognitive performance generally either improved or remained stable postbaseline. There was no case of interstitial cystitis or respiratory depression. Treatment-emergent dissociative symptoms were transient and generally resolved within 1.5 hours postdose. Montgomery-Åsberg Depression Rating Scale total score decreased during the IND phase, and this reduction persisted during the OP/MAINT phase (mean [SD] change from baseline of respective phase to endpoint: IND, -16.4 [8.76]; OP/MAINT, 0.3 [8.12]). CONCLUSIONS: Long-term esketamine nasal spray plus new OAD therapy had a manageable safety profile, and improvements in depression appeared to be sustained in patients with TRD. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02497287. © Copyright 2020 Physicians Postgraduate Press, Inc.
| Item Type: | Article |
|---|---|
| Funders: | UNSPECIFIED |
| Uncontrolled Keywords: | Ketamine; Antidepressive Agents; Rapid antidepressant |
| Subjects: | R Medicine |
| Divisions: | Faculty of Medicine |
| Depositing User: | Ms. Juhaida Abd Rahim |
| Date Deposited: | 10 Jun 2020 08:22 |
| Last Modified: | 10 Jun 2020 08:22 |
| URI: | http://eprints.um.edu.my/id/eprint/24773 |
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