Clinical trial 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
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depressive Disorder, Major
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2016-09-29
Enrollment: 27
Sex: ALL
Minimum age (years): 22
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: 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
timeFrame: Part A: Day 2
measure: The Effect of a Single 84-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
timeFrame: Part B: Day 1
measure: The Effect of a Single 84-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
timeFrame: Part B: Day 11
measure: The Effect of a Single 84-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
timeFrame: Part B: Day 18
measure: The Effect of a Single 84-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
timeFrame: Part B: Day 25
Secondary outcomes:
measure: Effect on Subjective Driving Ability Scale
timeFrame: Part A: Day 2; Part B: Day 1, 11, 18 and 25
measure: Karolinska Sleepiness Scale (KSS) Score
timeFrame: Part A: Day 2; Part B: Day 1, 11, 18 and 25
measure: Efficacy Measured by the Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline; Part A: Predose, Day 2; Part B: Predose, Days 1, 11, 18, and 25; End of study (up to Day 98)
measure: Effects on Suicidal Ideation/Behavior Measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline; Part A: Predose, Day 2; Part B: Predose, Days 1, 11, 18, and 25; End of study (up to Day 98)
measure: Effects on Dissociative Symptoms Using the Clinician-Administered Dissociative State Scale (CADSS)
timeFrame: Baseline; Part A: Predose, Day 1; Part B: Predose, Days 1, 11, 18, and 25
measure: Potential Relationship Between Changes in SDLP and the Plasma Concentration of Esketamine and Noresketamine
timeFrame: Part A: 1 hour postdose (Day 1); Part B: 1 hour postdose (Day 11, 18 and 25)
measure: Effect on Subjective Mental Effort Scale
timeFrame: Part A: Day 2; Part B: Day 1, 11, 18 and 25
measure: Potential Relationship Between Changes in Mean Lateral Position (MLP) and the Plasma Concentration of Esketamine and Noresketamine
timeFrame: Part A: 1 hour postdose (Day 1); Part B: 1 hour postdose (Day 11, 18 and 25)
measure: Potential Relationship Between Changes in Mean Speed and the Plasma Concentration of Esketamine and Noresketamine
timeFrame: Part A: 1 hour postdose (Day 1); Part B: 1 hour postdose (Day 11, 18 and 25)
Other outcomes:
Locations:
city: Leiden
country: Netherlands
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Dijkstra FM, van de Loo AJ, Abdulahad S, Bosma ER, Hartog M, Huls H, Kuijper DC, de Vries E, Solanki B, Singh J, Aluisio L, Zannikos P, Stuurman FE, Jacobs GE, Verster JC. The effects of intranasal esketamine on on-road driving performance in patients with major depressive disorder or persistent depressive disorder. J Psychopharmacol. 2022 May;36(5):614-625. doi: 10.1177/02698811221078764. Epub 2022 Feb 25.