NL-OMON53268招募中不适用
Methodological trial to investigate the dose-response relationship, test-retest reliability and tolerance to repeated exposure of the 35% carbon dioxide experimental panic challenge in CO2-sensitive healthy volunteers - Methodological optimization of the CO2 challenge
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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 invasive
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Healthy male or female aged between 18 and 65 years (inclusive) at screening
- •who have been demonstrated to be sensitive to the panicogenic effects of the
- •CO2 challenge in previous studies;
- •2. Sensitivity to the fear-inducing effects of 35% CO2 double-breath inhalation
- •is defined as an increase from pre-CO2 to post-CO2 challenge in the following:
- •PSL-IV total scores >=4 with at least 1-point increase for at least 4 of the
- •symptoms specified in the PSL-IV and an increase on the Visual Analog Scale
- •(VAS) Fear of at least 25 mm;
- •3. BMI of 18-32 kg/m2 (inclusive);
- •4. Non-smoker for at least 3 months.
排除标准
- •1. Subjects with a clinically significant current or past personal or family
- •history of any psychiatric disorder as classified by DSM-4 or DSM-5 criteria.
- •2. Current or past history of alcohol or any substance abuse or dependence
- •disorder within the past 12 months;
- •3. Clinically significant ECG abnormalities;
- •4. Clinically significant abnormality of the lungs (e.g. COPD, asthma, lung
- •fibrosis) and hematologic diseases concerning hemoglobin (e.g. thalassemia and
- •sickle cell disease);
- •5. Important cardiovascular history, or suspicion of infarct, cardiomyopathy,
- •cardiac failure, TIA, angina pectoris, cardiac arrhythmias, CVA;
- •6. Personal or familial history of cerebral aneurysm.
研究者
相似试验
已完成
Unknown
Methodological optimization of the CO2 challengePanic disorder, anxiety disorderMental and Behavioural DisordersISRCTN13516283Centre for Human Drug Research20
已完成
2 期
The Study of Dose Response Relationship Evaluation of AryoSeven in Hemophilia PatientsCondition 1: Congenital Hemophilia A with inhibitors. Condition 2: Congenital Hemophilia B with inhibitors.Hereditary factor VIII deficiencyHereditary factor IX deficiencyIRCT20161202031193N3AryoGen Pharmed12
已完成
不适用
A study to investigate the efficacy and dose response of Euglena by questionnaires for a measure of the subjective well-beingHealthy individualsJPRN-UMIN000037200everage Brain Inc.210
已完成
Unknown
A study to evaluate the dose-response efficacy of body fat reduction by continuous ingestion of test food. (SWE-2023-07-HCRINK)ot applicableJPRN-UMIN000051748Suntory Wellness Limited200
招募中
不适用
ong Chain Omega-3 Polyunsaturated Fatty Acids and Heart Health in HumansMild hypertriglyceridaemic subjectsCardiovascular - Coronary heart diseaseACTRN12607000566437niversity of Wollongong120