A Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Participants With Treatment Resistant Depression
Summary
The purpose of this study is to evaluate the efficacy of fixed dosed intranasal esketamine compared to intranasal placebo, as an add-on to an oral antidepressant in Japanese participants with treatment-resistant depression (TRD), in improving depressive symptoms.
Timeline
- Start
- 2016-12-12
- Primary completion
- 2019-08-19
- Completion
- 2019-12-13
Outcome
Missed primary endpoint
registry analysis (superiority test); Esketamine 28 Milligrams (mg) vs Placebo; p = 0.475; Difference of Least Squares means -1.0 (90% CI -5.77 to 3.70); Dunnett adjustment; note: 1-sided NCT02918318 ↗
registry analysis (superiority test); Esketamine 56 mg vs Placebo; p = 0.504; Difference of Least Squares means 0.6 (90% CI -4.32 to 5.47); Dunnett adjustment; note: 1-sided NCT02918318 ↗
registry analysis (superiority test); Esketamine 84 mg vs Placebo; p = 0.482; Difference of Least Squares means -0.9 (90% CI -5.66 to 3.83); Dunnett adjustment; note: 1-sided NCT02918318 ↗
paper however, the difference between the esketamine and placebo groups was not statistically significant. PMID 34696742 ↗
Publications
- Ohnishi T, Wakamatsu A, Kobayashi H. Different symptomatic improvement pattern revealed by factor analysis between placebo response and response to Esketamine in treatment resistant depression. Psychiatry Clin Neurosci. 2022 Aug;76(8):377-383. doi: 10.1111/pcn.13379. Epub 2022 Jun 9.
- Takahashi N, Yamada A, Shiraishi A, Shimizu H, Goto R, Tominaga Y. 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. 2021 Oct 25;21(1):526. doi: 10.1186/s12888-021-03538-y.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Esketamine | Other / unclassified | 28 mg | Intranasal |
| Subject | Esketamine | Other / unclassified | 56 mg | Intranasal |
| Subject | Esketamine | Other / unclassified | 84 mg | Intranasal |