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

Depressive Disorder, Major

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

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source