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ID
Source
Brief title
Health condition
Panic disorders
Sponsors and support
Intervention
Outcome measures
Primary outcome
To investigate the difference in response between single and double vital capacity 35% CO2/65% O2 in terms of the occurrence of PA’s in healthy subjects as measured with the Panic Symptoms List-IV (PSL-IV) and VAS subjective anxiety and fear.
Secondary outcome
• explore whether the occurrence of PA’s on a single vital capacity inhalation 35% CO2/65% O2 predicts the occurrence of PA’s on a double vital capacity inhalation 35% CO2/65% O2.
• explore the temporal stability of the occurrence of 35% CO2/65% O2-induced PA’s in subjects who develop PA’s on a single vital capacity inhalation and subsequently receive a double vital capacity inhalation.
• explore the effects of single and double breath 35% CO2/65% O2 on heart rate, blood pressure, respiratory rate.
• explore differences in sensitivity to 35% CO2/65% O2 between male and female subjects
Background summary
Maastricht Instruments in collaboration with Maastricht University has recently developed the CO2 tolerance tester (CTT). The CTT
is a research instrument that safely and reliably induces PA’s by the protocolized administration of inhaled 35% CO2. In addition, the CTT simultaneously measures physiological changes associated with CO2-induced ANS activation such has heart rate and blood
pressure. In contrast to previous experimental CO2 set ups, the CTT yields integrated real time information on ANS panic-related
parameters following acute CO2 inhalation which can be readily combined with subjective assessments such as fear intensity. The CTT is particularly relevant to research in the field fear-related psychiatric disorders and is a potentially useful tool in CNS drug development with novel anxiolytic compounds.To the best of our knowledge no study has been previously published that compares single and double vital capacity 35% CO2
inhalation in a single study. Therefore, we aim to investigate the panicogenic effects of a single vs. a double vital capacity method 35% CO2 in healthy volunteers. We hypothesize that 35% CO2 double vital capacity inhalation is associated with a higher percentage of subjects experiencing a panic attack compared to single vital capacity inhalation. Subjects will be recruited in the Netherlands.
Study objective
To investigate the difference in response between single and double vital capacity 35% CO2/65% O2 in terms of the occurrence of PA’s in healthy subjects as measured with the Panic Symptoms List-IV (PSL-IV) and VAS subjective anxiety and fear.
Study design
Screening (physical examination medical history, urine analysis, vital signs)
Intervention
NA
Inclusion criteria
• Informed consent in writing.
• Healthy male or female aged between 18 and 55 years (inclusive) at screening.
• BMI of 18-32 kg/m2 (inclusive).
• Non-smoker for at least 3 months.
• Ability to communicate adequately with the Investigator in the Dutch language and is willing to comply with the study restrictions.
Exclusion criteria
• Current or past history of any psychiatric disorder as classified according to DSM-IV or DSM 5.
• Current or past history of alcohol or any substance abuse or dependence disorder within the past 12 months.
• 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.
• Subject drinks, on average, more than 8 cups of tea/coffee/cocoa/cola/caffeinated beverages (e.g., energy drink) per day.
• Subject has a clinically significant acute illness within 7 days prior to the CO2 challenge.
• 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
• Clinically significant ECG abnormalities.
• Clinically significant abnormality of the lungs (e.g. COPD, asthma, lung fibrosis) and hematologic diseases concerning hemoglobin (e.g. thalassemia and sickle cell disease).
• Important cardiovascular history, or suspicion of infarct, cardiomyopathy, cardiac failure, TIA, angina pectoris, cardiac arrhythmias, CVA.
• Personal or familial history of cerebral aneurysm.
• Pregnancy as demonstrated by urine pregnancy test during screening or at each study day.
• Use of any psychotropic drugs.
• Have a urine drug screen detecting illicit drug of abuse (morphine, benzodiazepines, cocaine, amphetamine, THC) or a positive alcohol breath test at screening or each study day.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6244 |
| NTR-old | NTR6424 |
| CCMO | NL61306.056.17 |
| OMON | NL-OMON45528 |