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
- Conditions
- depression10027946Major depressive disorder
- Registration Number
- NL-OMON43083
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>On-the-road driving test<br /><br>In each study period, a validated car driving test will be performed at a<br /><br>predetermined time after dosing. The subject*s task will be to operate a<br /><br>specially instrumented vehicle over a 100-km primary highway circuit, while<br /><br>maintaining a constant speed (95 km/h) and steady lateral position between the<br /><br>delineated boundaries of the right (slower) traffic lane. SDLP (cm), ie, the<br /><br>weaving of the car, is the primary outcome variable. Standard deviation of<br /><br>speed (SDS, km/h) will be a secondary variable. Mean lateral position (MLP, +/-<br /><br>cm), and mean speed (MS, km/h) are control variables</p><br>
- Secondary Outcome Measures
Name Time Method