CompletedPhase 1ketamine
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
Sponsored by Janssen Research & Development, LLC
NCT ID
NCT02919579
Target Enrollment
27 participants
Start Date
2016-10-07
Est. Completion
2018-06-29
About This Study
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 Studied
Interventions
- •Placebo (Intranasal)
- •Esketamine
- •Alcohol
- •Placebo (Oral)
Eligibility
Age:22 Years - 60 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: * Willing and able to adhere to the prohibitions and restrictions specified in this protocol * If a woman, must have a negative serum beta human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test on Day 1 of Period 1 in Part A and prior to study drug administration in Part B * Comfortable with self-administration of intranasal medication and able to follow instructions provided * Normal visual acuity (corrected or uncorrected) * Based on self-report, able to consume an amount of alcohol that typically produces a blood alcohol concentration (BAC) of 0.05 percent (that is, 2 to 3 alcoholic drinks ingested within 2 hours on a single occasion) Exclusion Criteria: * Current or prior diagnosis of psychosis/psychotic or bipolar disorder * Primary sleep disorder, such as insomnia, requiring pharmacological intervention at Screening * Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or Day 1 of Period 1 as deemed appropriate by the investigator * Clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram (ECG) at screening or Day 1 of Period 1 as deemed appropriate by the investigator * History of moderate or severe use disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV or DSM-5) criteria within 1 year before screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening and Day 1 of Period 1
Study Locations (1)
Leiden, Netherlands