A Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression
Summary
The purpose of this study is to evaluate the efficacy of switching adult participants with treatment-resistant depression (TRD) from a prior antidepressant treatment (to which they have not responded) to flexibly dosed intranasal esketamine (56 milligram \[mg\] or 84 mg) plus a newly initiated oral antidepressant compared with switching to a newly initiated oral antidepressant (active comparator) plus intranasal placebo, in improving depressive symptoms. Efficacy will be assessed by the change from baseline in the Montgomery Asberg Depression Rating Scale (MADRS) total score from Day 1 (before randomization) to the end of the 4-week double-blind treatment phase.
Timeline
- Start
- 2018-05-25
- Primary completion
- 2021-04-13
- Completion
- 2021-04-13
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry analysis (superiority test); Intranasal Esketamine + Oral Antidepressant (AD); p = 0.123; Difference of Least Square (LS) Means -2.0 (95% CI -4.64 to 0.55); reads as missed primary endpoint NCT03434041 ↗
release “adults with treatment-resistant depression showed that flexibly dosed esketamine nasal spray plus a newly initiated oral antidepressant demonstrated a statistically significant, clinically meaningful rapid reduction” reads as met primary endpoint jnj.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Esketamine | Other / unclassified | 56 mg | Intranasal |
| Subject | Esketamine | Other / unclassified | 84 mg | Intranasal |
| Background | Duloxetine | Small molecule | 60 mg | Oral |
| Background | Escitalopram | Small molecule | 20 mg | Oral |
| Background | Sertraline | Small molecule | 200 mg | Oral |
| Background | Venlafaxine | Small molecule | 225 mg | Oral |