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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-07

Study Completion Date

2018-06-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Depressive Disorder, Major

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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

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.

Group Type EXPERIMENTAL

Placebo (Intranasal)

Intervention Type DRUG

Participants will receive intranasal placebo in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.

Esketamine

Intervention Type DRUG

Participants will receive intranasal esketamine in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.

Alcohol

Intervention Type OTHER

Participants will receive oral alcohol in Part A (as per the treatment sequence in period 1,2 and 3).

Placebo (Oral)

Intervention Type DRUG

Participants will receive oral placebo in Part A (as per the treatment sequence in period 1,2 and 3).

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

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

Group Type EXPERIMENTAL

Placebo (Intranasal)

Intervention Type DRUG

Participants will receive intranasal placebo in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.

Esketamine

Intervention Type DRUG

Participants will receive intranasal esketamine in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.

Alcohol

Intervention Type OTHER

Participants will receive oral alcohol in Part A (as per the treatment sequence in period 1,2 and 3).

Placebo (Oral)

Intervention Type DRUG

Participants will receive oral placebo in Part A (as per the treatment sequence in period 1,2 and 3).

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

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

Group Type EXPERIMENTAL

Placebo (Intranasal)

Intervention Type DRUG

Participants will receive intranasal placebo in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.

Esketamine

Intervention Type DRUG

Participants will receive intranasal esketamine in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.

Alcohol

Intervention Type OTHER

Participants will receive oral alcohol in Part A (as per the treatment sequence in period 1,2 and 3).

Placebo (Oral)

Intervention Type DRUG

Participants will receive oral placebo in Part A (as per the treatment sequence in period 1,2 and 3).

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

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

Group Type EXPERIMENTAL

Placebo (Intranasal)

Intervention Type DRUG

Participants will receive intranasal placebo in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.

Esketamine

Intervention Type DRUG

Participants will receive intranasal esketamine in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.

Alcohol

Intervention Type OTHER

Participants will receive oral alcohol in Part A (as per the treatment sequence in period 1,2 and 3).

Placebo (Oral)

Intervention Type DRUG

Participants will receive oral placebo in Part A (as per the treatment sequence in period 1,2 and 3).

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

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

Group Type EXPERIMENTAL

Placebo (Intranasal)

Intervention Type DRUG

Participants will receive intranasal placebo in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.

Esketamine

Intervention Type DRUG

Participants will receive intranasal esketamine in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.

Alcohol

Intervention Type OTHER

Participants will receive oral alcohol in Part A (as per the treatment sequence in period 1,2 and 3).

Placebo (Oral)

Intervention Type DRUG

Participants will receive oral placebo in Part A (as per the treatment sequence in period 1,2 and 3).

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

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

Group Type EXPERIMENTAL

Placebo (Intranasal)

Intervention Type DRUG

Participants will receive intranasal placebo in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.

Esketamine

Intervention Type DRUG

Participants will receive intranasal esketamine in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.

Alcohol

Intervention Type OTHER

Participants will receive oral alcohol in Part A (as per the treatment sequence in period 1,2 and 3).

Placebo (Oral)

Intervention Type DRUG

Participants will receive oral placebo in Part A (as per the treatment sequence in period 1,2 and 3).

Part B: Placebo+Esketamine

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

Group Type EXPERIMENTAL

Placebo (Intranasal)

Intervention Type DRUG

Participants will receive intranasal placebo in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.

Esketamine

Intervention Type DRUG

Participants will receive intranasal esketamine in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.

Interventions

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Placebo (Intranasal)

Participants will receive intranasal placebo in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.

Intervention Type DRUG

Esketamine

Participants will receive intranasal esketamine in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.

Intervention Type DRUG

Alcohol

Participants will receive oral alcohol in Part A (as per the treatment sequence in period 1,2 and 3).

Intervention Type OTHER

Placebo (Oral)

Participants will receive oral placebo in Part A (as per the treatment sequence in period 1,2 and 3).

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No