anxiety disorders Panic disorders
Conditions
Interventions
None listed
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 64 Years
Inclusion 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
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; 6. Personal or familial history of cerebral aneurysm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study aims to illuminate the primary endpoints of the following three objectives as follows: 1. The objective is to discern and contrast the frequency and intensity of panic attacks induced by a single vs. a double vital capacity inhalation of 35% CO2/65% O2. We will accomplish this by quantifying the difference in pre- and post-CO2 challenge metrics - namely PSL-IV, VAS Fear, and VAS Discomfort. The goal is to reveal any statistically significant distinctions in the frequency and intensity of panic reactions between these two inhalation scenarios. 2. The objective is to scrutinize the consistency and reliability of panic reactions induced by the repeated inhalation of double vital capacity 35% CO2/65% O2 in CO2-sensitive, healthy volunteers. We will accomplish this by quantifying the difference in pre- and post-CO2 challenge metrics - specifically PSL-IV, VAS Fear, and VAS Discomfort, between the initial and subsequent inhalation tests. The goal is to determine whether repeated exposures yield statistically significant consistency in the frequency and intensity of panic responses among the study participants. 3. The objective is to discern and contrast the persistence of sensitivity to the panicogenic effects of CO2 in healthy participants, previously identified as CO2-sensitive, over an extended period. We plan to accomplish this by quantifying the variation in pre- and post-CO2 challenge metrics, specifically PSL-IV, VAS Fear, and VAS Discomfort, between these two timepoints - initial assessment and years later. The ultimate aim is to establish whether there exist statistically significant distinctions in the frequency and intensity of panic reactions over time, indicating a maintained sensitivity or alteration to the CO2 challenge. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Explore the effects of single and (repeated) double breath 35% CO2/65% O2 on heart rate and blood pressure in CO2-sensitive healthy volunteers. • Explore the effects of single and (repeated) double breath 35% CO2/65% O2 on neuro-endocrine mediated autonomic nervous system activation and orexin/hypocretin release in CO2-sensitive healthy volunteers. • Explore the relationship between baseline personality and temperament characteristics and individual response to CO2 in CO2-sensitive healthy volunteers. | — |
Countries
Netherlands
Outcome results
None listed