Efficacy and safety of fixed doses of intranasal Esketamine as an add-on therapy to Oral antidepressants in Japanese patients with treatment-resistant depression: a phase 2b randomized clinical study
BMC Psychiatry October 31, 2021 Nagahide Takahashi, Aya Yamada, Ayako Shiraishi et al. 56 citations
In a Phase 2b randomized controlled trial of Japanese adults with treatment-resistant depression, adding esketamine nasal spray (28, 56, or 84 mg) to a new oral antidepressant did not significantly improve depressive symptoms more than placebo plus antidepressant. At day 28, Montgomery-Asberg Depression Rating Scale scores decreased by about 15 points in all groups, including placebo. Common side effects from esketamine included increased blood pressure, dissociation, dizziness, drowsiness, nausea, numbness, vertigo, and headache, each occurring more than twice as often as with placebo. The authors conclude that efficacy was not established and further research is needed.