depression Major depressive disorder
Conditions
Interventions
In Part A, intranasal esketamine or placebo (according to the sequence to which
the subject randomized) will be administered on Day 1 of each period as
follows: each 28-mg dose of esketamine will be
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 99 Years
Inclusion 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 selfadministration of intranasal medication and able to follow instructions provided Normal visual acuity (corrected or uncorrected) Based on selfreport, 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
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 12lead 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 (DSMIV or DSM5) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| On-the-road driving test In each study period, a validated car driving test will be performed at a predetermined time after dosing. The subject*s task will be to operate a specially instrumented vehicle over a 100-km primary highway circuit, while maintaining a constant speed (95 km/h) and steady lateral position between the delineated boundaries of the right (slower) traffic lane. SDLP (cm), ie, the weaving of the car, is the primary outcome variable. Standard deviation of speed (SDS, km/h) will be a secondary variable. Mean lateral position (MLP, +/- cm), and mean speed (MS, km/h) are control variables | — |
Secondary
| Measure | Time frame |
|---|---|
| Karolinska Sleepiness Scale (KSS), a subject-reported assessment used to rate sleepiness on a scale of 1 to 9, ranging from *extremely alert* (1) to *very sleepy, great effort to keep awake, fighting sleep (9). Subjective assessments of driving performance the perceived quality of their driving performance on a visual analog scale from 0 (*I drove exceptionally poorly*) to 20 (*I drove exceptionally well*) around a midpoint of *I drove normally*. A pharmacogenomic blood sample (10 mL) will be collected on Day 1 from all subjects for analysis of cytochrome P450 CYP2B6. Safety and tolerability will be assessed from the time of consent until the end of the study. Safety and tolerability assessments will include: adverse events, 12-lead electrocardiograms (ECGs), vital signs, clinical laboratory results, and physical examinations. The C-SSRS will be performed to assess suicidal ideation and behavior, and the CADSS will be administered to assess treatment-emergent dissociative symptoms. | — |
Countries
Netherlands
Outcome results
None listed