A Study to Evaluate the Effects of a Single-Dose and Repeat-Administration of Intranasal Esketamine on On-Road Driving in Participants With Major Depressive Disorder

PHASE1CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

October 7, 2016

Primary Completion Date

June 29, 2018

Study Completion Date

June 29, 2018

Conditions
Depressive Disorder, Major
Interventions
DRUG

Placebo (Intranasal)

Participants will receive intranasal placebo in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.

DRUG

Esketamine

Participants will receive intranasal esketamine in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.

OTHER

Alcohol

Participants will receive oral alcohol in Part A (as per the treatment sequence in period 1,2 and 3).

DRUG

Placebo (Oral)

Participants will receive oral placebo in Part A (as per the treatment sequence in period 1,2 and 3).

Trial Locations (1)

Unknown

Leiden

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02919579 - A Study to Evaluate the Effects of a Single-Dose and Repeat-Administration of Intranasal Esketamine on On-Road Driving in Participants With Major Depressive Disorder | Biotech Hunter | Biotech Hunter