CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 202 enrolled
Drug / intervention
Placebo +3 moredrug
Likely dose
Intranasal esketamine (28 mg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02918318
NCT02918318Phase 2Completed
CompareCT.gov

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

Janssen Pharmaceutical K.K.·interventional·Posted Sep 28, 2016·Updated Apr 29, 2025

In Brief

A Phase 2 clinical trial evaluating Placebo, Intranasal esketamine (28 mg), and 2 other interventions for Depression. Completed, enrolled 202 participants across 43 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 28, 2016
Enrollment StartDec 12, 2016
Primary CompletionAug 19, 2019
Study CompletionDec 13, 2019
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.8 years ago

Interventions

Placebodrug

Participant will receive 1 spray of placebo to each nostril at 0 minute, 5 minutes and 10 minutes.

Intranasal esketamine (28 mg)drug

Participant will receive 1 spray of Esketamine to each nostril at 0 minute and placebo at 5 minutes and 10 minutes.

Intranasal esketamine (56 mg)drug

Participant will receive 1 spray of Esketamine to each nostril at 0 minute, 5 minutes and placebo at 10 minutes.

Intranasal esketamine (84 mg)drug

Participant will receive 1 spray of Esketamine to each nostril at 0 minute, 5 minutes and 10 minutes.