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 (DriveSaFe2)

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Depressive Disorder, Major

Treatments: Drug: Placebo (Intranasal); Other: Alcohol; Drug: Placebo (Oral); Drug: Esketamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02919579

CR108228

54135419TRD1019 (Other Identifier)

2016-002424-86 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 22 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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27 participants in 7 patient groups

Part A: Sequence ABC (Placebo+Alcohol+Esketamine)

Experimental group

Description:

Participants will receive intranasal placebo on Day 1 and oral placebo on Day 2 \[Treatment A\] in Period 1, then intranasal placebo on Day 1 and Oral alcohol on Day 2 \[Treatment B\] in Period 2, followed by intranasal esketamine on Day 1 and oral placebo on Day 2 \[Treatment C\] in Period 3.

Treatment:

Drug: Esketamine

Drug: Placebo (Oral)

Other: Alcohol

Drug: Placebo (Intranasal)

Part A: Sequence BCA (Placebo+Alcohol+Esketamine)

Experimental group

Description:

Participants will receive Treatment B in Period 1, then Treatment C in Period 2, followed by Treatment A in Period 3.

Treatment:

Drug: Esketamine

Drug: Placebo (Oral)

Other: Alcohol

Drug: Placebo (Intranasal)

Part A: Sequence CAB (Placebo+Alcohol+Esketamine)

Experimental group

Description:

Participants will receive Treatment C in Period 1, then Treatment A in Period 2, followed by Treatment B in Period 3.

Treatment:

Drug: Esketamine

Drug: Placebo (Oral)

Other: Alcohol

Drug: Placebo (Intranasal)

Part A: Sequence CBA (Placebo+Alcohol+Esketamine)

Experimental group

Description:

Participants will receive Treatment C in Period 1, then Treatment B in Period 2, followed by Treatment A in Period 3.

Treatment:

Drug: Esketamine

Drug: Placebo (Oral)

Other: Alcohol

Drug: Placebo (Intranasal)

Part A: Sequence ACB (Placebo+Alcohol+Esketamine)

Experimental group

Description:

Participants will receive Treatment A in Period 1, then Treatment C in Period 2, followed by Treatment B in Period 3.

Treatment:

Drug: Esketamine

Drug: Placebo (Oral)

Other: Alcohol

Drug: Placebo (Intranasal)

Part A: Sequence BAC (Placebo+Alcohol+Esketamine)

Experimental group

Description:

Participants will receive Treatment B in Period 1, then Treatment A in Period 2, followed by Treatment C in Period 3.

Treatment:

Drug: Esketamine

Drug: Placebo (Oral)

Other: Alcohol

Drug: Placebo (Intranasal)

Part B: Placebo+Esketamine

Experimental group

Description:

Participants will receive intranasal placebo on Day 1, followed by intranasal esketamine on Days 4, 8, 11, 15, 18, 22 and 25.

Treatment:

Drug: Esketamine

Drug: Placebo (Intranasal)