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

Centre for Human Drug Research0 sites20 target enrollmentFebruary 21, 2024

Overview

No summary available.

Registry

who.int

Start Date

February 21, 2024

End Date

December 31, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Sponsor

•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.

•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.