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Study to Assess the Effects of Esketamine on Safety of On-road Driving in Healthy Participants

NCT02228239 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2014-12-30

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effect of esketamine compared to placebo on driving performance as assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test in healthy participants.

Conditions

  • Healthy

Interventions

DRUG

Esketamine

Esketamine 84 milligram (mg) \[3\*1 of spray in each nostril\] will be administered intranasally on Day 1 in one of the treatment periods.

DRUG

Mirtazapine

Mirtazapine 30 mg capsule will be administered orally on Day 1 in one of the treatment periods.

DRUG

Placebo (Matched to Esketamine)

Placebo \[3\*1 in each nostril\] will be administered intranasally on Day 1 in one of the treatment periods.

DRUG

Placebo (Matched to Mirtazapine)

Placebo capsule will be administered orally on Day 1 in one of the treatment periods.

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
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Netherlands

Study Locations

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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 NCT02228239 on ClinicalTrials.gov