|- candidate number||27161|
|- NTR Number||NTR6424|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-mei-2017|
|- Secondary IDs||NL61306.056.17 CHDR1714|
|- Public Title||An observational study into the occurrence of panic attacks after inhalation of 65% oxygen and 35% carbon dioxide. |
|- Scientific Title||An explorative study to establish the panicogenic effects of a single versus double vital capacity 35% carbon dioxide inhalation challenge |
|- ACRONYM||35% CO2 single versus double inhalation study |
|- hypothesis||To investigate the difference in response between single and double vital capacity 35% CO2/65% O2 in terms of the occurrence of PAs in healthy subjects as measured with the Panic Symptoms List-IV (PSL-IV) and VAS subjective anxiety and fear.|
|- Healt Condition(s) or Problem(s) studied||Panic disorder|
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2017|
|- planned closingdate||18-mei-2017|
|- Target number of participants||20|
|- Primary outcome||To investigate the difference in response between single and double vital capacity 35% CO2/65% O2 in terms of the occurrence of PAs 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 PAs on a single vital capacity inhalation 35% CO2/65% O2 predicts the occurrence of PAs on a double vital capacity inhalation 35% CO2/65% O2.|
explore the temporal stability of the occurrence of 35% CO2/65% O2-induced PAs in subjects who develop PAs 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
|- Timepoints||Screening (physical examination medical history, urine analysis, vital signs)|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD, PhD Gabriel Jacobs|
|- CONTACT for SCIENTIFIC QUERIES||MD Sander Brooks|
|- Sponsor/Initiator ||CHDR|
(Source(s) of Monetary or Material Support)
|- Brief 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 PAs 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. |
|- Main changes (audit trail)|
|- RECORD||2-mei-2017 - 28-jun-2017|