NL-OMON53268
Recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Centre for Human Drug Research
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
Outcomes
Primary Outcomes
Not specified
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