Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT06789705
Eligibility Criteria:
Inclusion criteria patients:
1\. Adult patients with confirmed diagnosis of Arginine Vasopressin deficiency (central diabetes insipidus)2 or with only anterior pituitary deficiency
Inclusion criteria healthy controls:
1. Adult healthy controls
2. Matched for age, sex, Body mass index, and oestrogen replacement/menopause/hormonal contraceptives to patients
3. No medication, except hormonal contraception
Exclusion Criteria:
1. Participation in a trial with investigational drugs within 30 days
2. Illicit substance use (except for cannabis) more than 10 times in lifetime or any time within the previous two months
3. Consumption of alcoholic beverages \>15 drinks/week
4. Tobacco smoking \>10 cigarettes/day
5. Cardiovascular disease (coronary artery disease, heart failure Left ventricular ejection fraction \<40%, stroke in the last 3 months, atrial fibrillation/flatter, Wolff-Parkinson-White-Syndrome)
6. Uncontrolled arterial hypertension (\>140/90 mmHg) or hypotension (\<85mmHg)
7. Current or previous major psychiatric disorder (e.g., major depression, schizophrenia spectrum disorder)
8. Psychotic disorder in first-degree relatives
9. Regular intake of selective serotonin reuptake inhibitors or Monoamine oxidase inhibitors
10. Pregnancy and breastfeeding
11. Diagnosed Chronic Kidney Disease \> grade III (glomerular filtration rate \< 30ml/min)
12. Diagnosed liver cirrhosis or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) levels 2.5 times above the normal range
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06789705
Study Brief:
Protocol Section:
NCT06789705