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

NCT02918318 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2025-04-29

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Janssen Pharmaceutical K.K.

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutical K.K., Japan Clinical Trial · Janssen Pharmaceutical K.K.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-12
Primary Completion
2019-08-19
Completion
2019-12-13

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02918318 on ClinicalTrials.gov