NCT03434041

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

A Randomized, Double-blind, Multicenter Active-controlled Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depressive Disorder, Treatment-Resistant

Interventions

Type	Name	Description
DRUG	Esketamine 56 mg	Participants will self-administer 56 mg of esketamine as intranasal spray.
DRUG	Esketamine 84 mg	Participants will self-administer 84 mg of esketamine as intranasal spray.
DRUG	Placebo	Participants will self-administer matching placebo as intranasal spray.
DRUG	Duloxetine (Oral Antidepressant)	Duloxetine can be selected as the oral antidepressant medication based on investigator's discretion. The minimum therapeutic dose is 60 milligram per day (mg/day).
DRUG	Escitalopram (Oral Antidepressant)	Escitalopram can be selected as the oral antidepressant medication based on investigator's discretion. Escitalopram will be started at a dose of 10 mg/day and up-titrated to a maximum dose of 20 mg/day.
DRUG	Sertraline (Oral Antidepressant)	Sertraline can be selected as the oral antidepressant medication based on investigator's discretion. Sertraline will be started at a dose of 50 mg/day and up-titrated to a maximum dose of 200 mg/day.
DRUG	Venlafaxine Extended Release (XR) (Oral Antidepressant)	Venlafaxine XR can be selected as the oral antidepressant medication based on investigator's discretion. Venlafaxine XR will be started at a dose of 75 mg/day and up-titrated to a maximum dose of 225 mg/day.

Timeline

• Start date: 2018-05-25
• Primary completion: 2021-04-13
• Completion: 2021-04-13
• First posted: 2018-02-15
• Last updated: 2025-04-29
• Results posted: 2022-05-24

Locations

30 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study