NCT02918318

A Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Participants With Treatment Resistant Depression

A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Subjects With Treatment Resistant Depression

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: All
• Age: 20 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression

Interventions

Type	Name	Description
DRUG	Placebo	Participant will receive 1 spray of placebo to each nostril at 0 minute, 5 minutes and 10 minutes.
DRUG	Intranasal esketamine (28 mg)	Participant will receive 1 spray of Esketamine to each nostril at 0 minute and placebo at 5 minutes and 10 minutes.
DRUG	Intranasal esketamine (56 mg)	Participant will receive 1 spray of Esketamine to each nostril at 0 minute, 5 minutes and placebo at 10 minutes.
DRUG	Intranasal esketamine (84 mg)	Participant will receive 1 spray of Esketamine to each nostril at 0 minute, 5 minutes and 10 minutes.

Timeline

• Start date: 2016-12-12
• Primary completion: 2019-08-19
• Completion: 2019-12-13
• First posted: 2016-09-28
• Last updated: 2025-04-29
• Results posted: 2020-10-19

Locations

43 sites across 1 country: Japan