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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

NCT02919579 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-04-27

No results posted yet for this study

Summary

The primary purpose of this study is to evaluate the effect of a single 84-milligram (mg) dose of intranasal esketamine compared to placebo, on next day driving performance and repeated administration of 84 mg intranasal esketamine on same-day driving performance as assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test.

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).

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-07
Primary Completion
2018-06-29
Completion
2018-06-29

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

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 NCT02919579 on ClinicalTrials.gov