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

A Placebo- and Active-Controlled Study to Evaluate the Effects of a Single-Dose and Repeat-Administration of Intranasal Esketamine on On-Road Driving in Subjects With Major Depressive Disorder (DriveSaFe2)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 22 Years – 60 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2016-10-07
• Primary completion: 2018-06-29
• Completion: 2018-06-29
• First posted: 2016-09-29
• Last updated: 2025-04-27

Locations

1 site across 1 country: Netherlands