NCT02133001View on ClinicalTrials.gov

A Double-blind Study to Assess the Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Participants Who Are Assessed to be at Imminent Risk for Suicide

PHASE2CompletedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

May 23, 2014

Primary Completion Date

February 1, 2016

Study Completion Date

February 1, 2016

Conditions
Major Depressive Disorder
Interventions
DRUG

Esketamine

Esketamine 84 mg will be self-administered by participants as intranasal spray as two times a week, for 4 weeks (that is, Day 1,4,8,11,15,18,22,25). Dose may be reduced to 56 mg per day based on Investigator's discretion.

DRUG

Placebo

Matching placebo will be self-administered by participants as intranasal spray as two times a week, for 4 weeks (that is, Day 1,4,8,11,15,18,22,25).

Trial Locations (14)

Unknown

Birmingham

San Diego

Hartford

New Haven

Atlanta

Iowa City

Baltimore

Towson

Ann Arbor

Rochester

Cincinnati

Philadelphia

Pittsburgh

Houston

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02133001 - A Double-blind Study to Assess the Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Participants Who Are Assessed to be at Imminent Risk for Suicide | Biotech Hunter | Biotech Hunter