Panic disorder, anxiety disorder Mental and Behavioural Disorders
Conditions
Interventions
Subject Recruitment and Study Procedure Overview
Participants are identified through a search in our internal database and contacted via email, which includes a brief overview of the study. Interested
Sponsors
Centre for Human Drug Research
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) 1. Fear measured using Panic Symptom List 2. Discomfort measured using Visual Analogue Scales | — |
Secondary
| Measure | Time frame |
|---|---|
| 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): 1. State-Trait Anxiety Inventory Y1 2. Saliva cortisol 3. Saliva alpha-amylase 4. Serum cortisol 5. ACTH 6. Prolactin Specific collection times for the biochemical markers in plasma (serum cortisol, ACTH, prolactin, and orexin-1) are strategically scheduled around each CO2 challenge at five intervals: a pre-challenge sample 15 minutes before, a sample within the immediate 5-minute window preceding the challenge, one directly in the 5-minute period following the challenge, and additional samples at 15-, 30-, 60-, and 120-minutes post-challenge. Similarly, saliva samples for cortisol and alpha-amylase levels are methodically obtained at defined times around the CO2 challenge: one sample 10 minutes prior to the challenge, another within the 1-minute period just before the challenge, a third within the 1-minute period immediately after the challenge, and subsequent samples at 10, 20, 40, and 60 minutes after the challenge. Personality assessments administered only once at the beginning of the study on Day 1: 7. Temperament and Character Inventory (TCI) 8. Dutch Personality Questionnaire (DPQ), 9. State-Trait Anxiety Inventory Y2, | — |
Countries
Netherlands
Contacts
Public ContactAsso Safai Pour
Outcome results
None listed