A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression

Summary

The purpose of this study is to assess the safety and tolerability of esketamine nasal spray in participants with treatment-resistant depression (TRD).

Timeline

Start

2016-06-09

Primary completion

2022-12-30

Completion

2022-12-30

Publications

• Zaki N, Chen LN, Lane R, Doherty T, Drevets WC, Morrison RL, Sanacora G, Wilkinson ST, Young AH, Lacerda ALT, Paik JW, Popova V, Fu DJ. Safety and efficacy with esketamine in treatment-resistant depression: long-term extension study. Int J Neuropsychopharmacol. 2025 Jun 6;28(6):pyaf027. doi: 10.1093/ijnp/pyaf027.
• Castro M, Wilkinson ST, Al Jurdi RK, Petrillo MP, Zaki N, Borentain S, Fu DJ, Turkoz I, Sun L, Brown B, Cabrera P. Efficacy and Safety of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Who Completed a Second Induction Period: Analysis of the Ongoing SUSTAIN-3 Study. CNS Drugs. 2023 Aug;37(8):715-723. doi: 10.1007/s40263-023-01026-3. Epub 2023 Aug 9.
• Zaki N, Chen LN, Lane R, Doherty T, Drevets WC, Morrison RL, Sanacora G, Wilkinson ST, Popova V, Fu DJ. Long-term safety and maintenance of response with esketamine nasal spray in participants with treatment-resistant depression: interim results of the SUSTAIN-3 study. Neuropsychopharmacology. 2023 Jul;48(8):1225-1233. doi: 10.1038/s41386-023-01577-5. Epub 2023 May 12.
• Starr HL, Abell J, Larish A, Lewis S, DeMuro C, Gogate J, Jamieson C, Daly E, Zaki N, Kramer M. Self-reported review of the value of esketamine in patients with treatment-resistant depression: Understanding the patient experience in the STRIVE Study. Psychiatry Res. 2020 Nov;293:113376. doi: 10.1016/j.psychres.2020.113376. Epub 2020 Aug 8.

Drugs

Indications