A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder

Summary

The primary purpose of this study is to evaluate the efficacy of flexibly dosed esketamine nasal spray compared with quetiapine extended-release (XR), both in combination with a continuing selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI), in achieving remission in participants who have treatment-resistant major depressive disorder (MDD) with a current moderate to severe depressive episode.

Timeline

Start

2020-08-21

Primary completion

2022-01-20

Completion

2022-07-15

Publications

• McIntyre RS, Bitter I, Buyze J, Fagiolini A, Godinov Y, Gorwood P, Ito T, Oliveira-Maia AJ, Vieta E, Werner-Kiechle T, Young AH, Reif A. Safety and tolerability of esketamine nasal spray versus quetiapine extended release in patients with treatment resistant depression. Eur Neuropsychopharmacol. 2024 Aug;85:58-65. doi: 10.1016/j.euroneuro.2024.05.009. Epub 2024 Jul 1.
• Lan CH, Wei JC. Esketamine Nasal Spray versus Quetiapine for Resistant Depression. N Engl J Med. 2024 Jan 4;390(1):93-94. doi: 10.1056/NEJMc2313230. No abstract available.
• Horowitz MA, Ploderl M, Naudet F. Esketamine Nasal Spray versus Quetiapine for Resistant Depression. N Engl J Med. 2024 Jan 4;390(1):93. doi: 10.1056/NEJMc2313230. No abstract available.
• Reif A, Bitter I, Buyze J, Cebulla K, Frey R, Fu DJ, Ito T, Kambarov Y, Llorca PM, Oliveira-Maia AJ, Messer T, Mulhern-Haughey S, Rive B, von Holt C, Young AH, Godinov Y; ESCAPE-TRD Investigators. Esketamine Nasal Spray versus Quetiapine for Treatment-Resistant Depression. N Engl J Med. 2023 Oct 5;389(14):1298-1309. doi: 10.1056/NEJMoa2304145.

Drugs

Indications