NL-OMON45528已完成不适用
An explorative study to establish the panicogenic effects of a single versus double vital capacity 35% carbon dioxide inhalation challenge - 35% CO2 single versus double inhalation study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Informed consent in writing.
- •2. Healthy male or female aged between 18 and 55 years (inclusive) at screening.
- •3. BMI of 18-32 kg/m2 (inclusive).
- •4. Non-smoker for at least 3 months.
- •5. Ability to communicate adequately with the Investigator in the Dutch language and is willing to comply with the study restrictions.
排除标准
- •1. Current or past history of any psychiatric disorder as classified according to DSM-IV or DSM 5.
- •2. Current or past history of alcohol or any substance abuse or dependence disorder within the past 12 months.
- •3. Presence of panic disorder as classified by DSM-IV and diagnosed by a psychiatrist or classified by the module Panic Disorder (E) of the MINI International Neuropsychiatric Interview during screening.
- •4. Subject drinks, on average, more than 8 cups of tea/coffee/cocoa/cola/caffeinated beverages (e.g., energy drink) per day.
- •5. Subject has a clinically significant acute illness within 7 days prior to the CO2 challenge.
- •6. Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg
- •7. Clinically significant ECG abnormalities.
- •8. Clinically significant abnormality of the lungs (e.g. COPD, asthma, lung fibrosis) and hematologic diseases concerning hemoglobin (e.g. thalassemia and sickle cell disease).
- •9. Important cardiovascular history, or suspicion of infarct, cardiomyopathy, cardiac failure, TIA, angina pectoris, cardiac arrhythmias, CVA.
- •10. Personal or familial history of cerebral aneurysm.
- •11. Pregnancy as demonstrated by urine pregnancy test during screening or at each study day.
- •12. Use of any psychotropic drugs.
- •13. Have a urine drug screen detecting illicit drug of abuse (morphine, benzodiazepines, cocaine, amphetamine, THC) or a positive alcohol breath test at screening of elke studiedag
研究者
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