NL-OMON43083已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
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 selfadministration of intranasal medication and able to follow instructions provided
- •Normal visual acuity (corrected or uncorrected)
- •Based on selfreport, 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 12lead 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 (DSMIV or DSM5) 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
研究者
相似试验
已完成
3 期
Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in COPD Patients With Moderate to Severe Airflow LimitatioCTRI/2012/12/003207ovartis Healthcare Pvt Ltd1,224
进行中（未招募）
不适用
Comparison of long-term safety of the combination product QVA149A against placebo and standard of care treatment in Chronic Obstructive Pulmonary Disease patients with moderate to severe airflow limitatioChronic Obstructive Pulmonary Disease (COPD)MedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2012-002057-38-SIovartis Pharma Service AG1,224
进行中（未招募）
1 期
Comparison of long-term safety of the combination product QVA149A against placebo and standard of care treatment in Chronic Obstructive Pulmonary Disease patients with moderate to severe airflow limitatioChronic Obstructive Pulmonary Disease (COPD)MedDRA version: 15.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855EUCTR2012-002057-38-HUovartis Pharma Service AG1,216
进行中（未招募）
不适用
Comparison of long-term safety of the combination product QVA149A against placebo and standard of care treatment in Chronic Obstructive Pulmonary Disease patients with moderate to severe airflow limitatioEUCTR2012-002057-38-GBovartis Pharma Service AG1,224
进行中（未招募）
不适用
Comparison of long-term safety of the combination product QVA149A against placebo and standard of care treatment in Chronic Obstructive Pulmonary Disease patients with moderate to severe airflow limitatioChronic Obstructive Pulmonary Disease (COPD)MedDRA version: 15.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2012-002057-38-LVovartis Pharma Service AG1,224