An explorative study to establish the panicogenic effects of a single versus double vital capacity 35% carbon dioxide inhalation challenge

Completed

• Conditions: anxiety disorders; Panic disorders; 10002861

• Registration Number: NL-OMON45528
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

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

Inclusion Criteria

1. Informed consent in writing.
2. Healthy male or female aged between 18 and 55 years (inclusive) at screening.
3. BMI of 18-32 kg/m2 (inclusive).
4. Non-smoker for at least 3 months.
5. Ability to communicate adequately with the Investigator in the Dutch language and is willing to comply with the study restrictions.

Exclusion Criteria

1. Current or past history of any psychiatric disorder as classified according to DSM-IV or DSM 5.
2. Current or past history of alcohol or any substance abuse or dependence disorder within the past 12 months.
3. Presence of panic disorder as classified by DSM-IV and diagnosed by a psychiatrist or classified by the module Panic Disorder (E) of the MINI International Neuropsychiatric Interview during screening.
4. Subject drinks, on average, more than 8 cups of tea/coffee/cocoa/cola/caffeinated beverages (e.g., energy drink) per day.
5. Subject has a clinically significant acute illness within 7 days prior to the CO2 challenge.
6. Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg
7. Clinically significant ECG abnormalities.
8. Clinically significant abnormality of the lungs (e.g. COPD, asthma, lung fibrosis) and hematologic diseases concerning hemoglobin (e.g. thalassemia and sickle cell disease).
9. Important cardiovascular history, or suspicion of infarct, cardiomyopathy, cardiac failure, TIA, angina pectoris, cardiac arrhythmias, CVA.
10. Personal or familial history of cerebral aneurysm.
11. Pregnancy as demonstrated by urine pregnancy test during screening or at each study day.
12. Use of any psychotropic drugs.
13. Have a urine drug screen detecting illicit drug of abuse (morphine, benzodiazepines, cocaine, amphetamine, THC) or a positive alcohol breath test at screening of elke studiedag

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Panic attacks will be assessed by the Panic Symptoms List-IV (PSL-IV) and VAS<br /><br>subjective anxiety and fear.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* explore whether the occurrence of PA*s on a single vital capacity inhalation<br /><br>35% CO2/65% O2 predicts occurrence of PA*s on a double vital capacity<br /><br>inhalation 35% CO2/65% O2.<br /><br>* explore the temporal stability of the occurrence of 35% CO2/65% O2-induced<br /><br>PA*s in subjects who develop PA*s on a single vital capacity inhalation and<br /><br>subsequently receive a double vital capacity inhalation.<br /><br>* explore the effects of single and double breath 35% CO2/65% O2 on heart rate,<br /><br>blood pressure, respiratory rate.<br /><br>* explore differences in sensitivity to 35% CO2/65% O2 between male and female<br /><br>subjects.</p><br>