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)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 22 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Placebo (Intranasal) (Drug)
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.
干预措施: Placebo (Intranasal) (Drug)
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.
干预措施: Esketamine (Drug)
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.
干预措施: Alcohol (Other)
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.
干预措施: Placebo (Oral) (Drug)
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.
干预措施: Esketamine (Drug)
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.
干预措施: Alcohol (Other)
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.
干预措施: Placebo (Oral) (Drug)
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.
干预措施: Placebo (Intranasal) (Drug)
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.
干预措施: Esketamine (Drug)
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.
干预措施: Alcohol (Other)
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.
干预措施: Placebo (Oral) (Drug)
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.
干预措施: Placebo (Intranasal) (Drug)
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.
干预措施: Esketamine (Drug)
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.
干预措施: Alcohol (Other)
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.
干预措施: Placebo (Oral) (Drug)
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.
干预措施: Placebo (Intranasal) (Drug)
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.
干预措施: Esketamine (Drug)
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.
干预措施: Alcohol (Other)
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.
干预措施: Placebo (Oral) (Drug)
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.
干预措施: Placebo (Intranasal) (Drug)
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.
干预措施: Esketamine (Drug)
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.
干预措施: Alcohol (Other)
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.
干预措施: Placebo (Oral) (Drug)
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.
干预措施: Placebo (Intranasal) (Drug)
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.
干预措施: Esketamine (Drug)
结局指标
主要结局
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
时间窗: Part A: Day 2
Driving performance will be assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test.
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
时间窗: Part B: Day 25
Driving performance will be assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test.
次要结局
- Effect on Subjective Driving Ability Scale(Part A: Day 2; Part B: Day 1, 11, 18 and 25)
- Effects on Suicidal Ideation/Behavior Measured by the Columbia Suicide Severity Rating Scale (C-SSRS)(Baseline; Part A: Predose, Day 2; Part B: Predose, Days 1, 11, 18, and 25; End of study (up to Day 98))
- Potential Relationship Between Changes in SDLP and the Plasma Concentration of Esketamine and Noresketamine(Part A: 1 hour postdose (Day 1); Part B: 1 hour postdose (Day 11, 18 and 25))
- Potential Relationship Between Changes in Mean Speed and the Plasma Concentration of Esketamine and Noresketamine(Part A: 1 hour postdose (Day 1); Part B: 1 hour postdose (Day 11, 18 and 25))
- Karolinska Sleepiness Scale (KSS) Score(Part A: Day 2; Part B: Day 1, 11, 18 and 25)
- Effects on Dissociative Symptoms Using the Clinician-Administered Dissociative State Scale (CADSS)(Baseline; Part A: Predose, Day 1; Part B: Predose, Days 1, 11, 18, and 25)
- Efficacy Measured by the Montgomery Asberg Depression Rating Scale (MADRS)(Baseline; Part A: Predose, Day 2; Part B: Predose, Days 1, 11, 18, and 25; End of study (up to Day 98))
- Effect on Subjective Mental Effort Scale(Part A: Day 2; Part B: Day 1, 11, 18 and 25)
- Potential Relationship Between Changes in Mean Lateral Position (MLP) and the Plasma Concentration of Esketamine and Noresketamine(Part A: 1 hour postdose (Day 1); Part B: 1 hour postdose (Day 11, 18 and 25))