A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression

Summary

The purpose of this open-label, multicenter study is to assess the long term safety and efficacy of intranasal esketamine plus an oral antidepressant in participants with treatment-resistant depression (TRD).

Timeline

Start

2015-09-30

Primary completion

2017-10-28

Completion

2017-10-28

Publications

• Oliveira-Maia AJ, Rive B, Godinov Y, Mulhern-Haughey S. Estimating the benefit of esketamine nasal spray versus real-world treatment on patient-reported functional remission: results from the ICEBERG study. Front Psychiatry. 2024 Oct 7;15:1459633. doi: 10.3389/fpsyt.2024.1459633. eCollection 2024.
• Oliveira-Maia AJ, Morrens J, Rive B, Godinov Y, Cabrieto J, Perualila N, Barbreau S, Mulhern-Haughey S. ICEBERG study: an indirect adjusted comparison estimating the long-term benefit of esketamine nasal spray when compared with routine treatment of treatment resistant depression in general psychiatry. Front Psychiatry. 2023 Oct 31;14:1250980. doi: 10.3389/fpsyt.2023.1250980. eCollection 2023.
• Oliveira-Maia AJ, Rive B, Morrens J, Godinov Y, Cabrieto J, Perualila N, Mulhern-Haughey S. Indirect adjusted comparison of 6-month clinical outcomes between esketamine nasal spray and other real-world polypharmacy treatment strategies for treatment resistant depression: results from the ICEBERG study. Front Psychiatry. 2023 Oct 31;14:1250987. doi: 10.3389/fpsyt.2023.1250987. eCollection 2023.
• Williamson D, Turkoz I, Wajs E, Singh JB, Borentain S, Drevets WC. Adverse Events and Measurement of Dissociation After the First Dose of Esketamine in Patients With TRD. Int J Neuropsychopharmacol. 2023 Mar 22;26(3):198-206. doi: 10.1093/ijnp/pyac081.
• Williamson DJ, Gogate JP, Kern Sliwa JK, Manera LS, Preskorn SH, Winokur A, Starr HL, Daly EJ. Longitudinal Course of Adverse Events With Esketamine Nasal Spray: A Post Hoc Analysis of Pooled Data From Phase 3 Trials in Patients With Treatment-Resistant Depression. J Clin Psychiatry. 2022 Sep 19;83(6):21m14318. doi: 10.4088/JCP.21m14318.
• Ochs-Ross R, Wajs E, Daly EJ, Zhang Y, Lane R, Lim P, Drevets WC, Steffens DC, Sanacora G, Jamieson C, Hough D, Manji H, Singh JB. Comparison of Long-Term Efficacy and Safety of Esketamine Nasal Spray Plus Oral Antidepressant in Younger Versus Older Patients With Treatment-Resistant Depression: Post-Hoc Analysis of SUSTAIN-2, a Long-Term Open-Label Phase 3 Safety and Efficacy Study. Am J Geriatr Psychiatry. 2022 May;30(5):541-556. doi: 10.1016/j.jagp.2021.09.014. Epub 2021 Oct 6.
• Wajs E, Aluisio L, Holder R, Daly EJ, Lane R, Lim P, George JE, Morrison RL, Sanacora G, Young AH, Kasper S, Sulaiman AH, Li CT, Paik JW, Manji H, Hough D, Grunfeld J, Jeon HJ, Wilkinson ST, Drevets WC, Singh JB. Esketamine Nasal Spray Plus Oral Antidepressant in Patients With Treatment-Resistant Depression: Assessment of Long-Term Safety in a Phase 3, Open-Label Study (SUSTAIN-2). J Clin Psychiatry. 2020 Apr 28;81(3):19m12891. doi: 10.4088/JCP.19m12891.
• Nijs M, Wajs E, Aluisio L, Turkoz I, Daly E, Janik A, Borentain S, Singh JB, DiBernardo A, Wiegand F. Managing Esketamine Treatment Frequency Toward Successful Outcomes: Analysis of Phase 3 Data. Int J Neuropsychopharmacol. 2020 Jul 29;23(7):426-433. doi: 10.1093/ijnp/pyaa027.

Drugs

Indications

No indication recorded.