Methodological optimization of the CO2 challenge

Not Applicable

Completed

• Conditions: Panic disorder, anxiety disorder; Mental and Behavioural Disorders

• Registration Number: ISRCTN13516283
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-12-31
• Study Start: 2024-02-21
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measured at Day 1, and subsequent sessions approximately one week apart (Day 8, Day 15, Day 22, and Day 29, with a 3-day margin of flexibility)<br>1. Fear measured using Panic Symptom List<br>2. Discomfort measured using Visual Analogue Scales