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

Recruiting

• Conditions: anxiety disorders; Panic disorders; 10002861

• Registration Number: NL-OMON53268
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

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;
6. Personal or familial history of cerebral aneurysm.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified