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:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT06036004
Eligibility Criteria:
Inclusion Criteria:
* Adult patients with a confirmed diagnosis of central diabetes insipidus based on accepted criteria
* Heightened anxiety levels (STAI - Trait subscale ≥ 39 score points) or alexithymia levels (impaired ability to identify and describe feelings; TAS-20 total ≥ 52 score points)
* Stable hormone replacement therapy for at least three months with desmopressin and, in case of additional anterior pituitary deficiencies, with the respective substitution therapies.
Exclusion Criteria:
* Participation in a trial with investigational drugs within 30 days
* Active substance use disorder within the last six months
* Consumption of alcoholic beverages \>15 drinks/week
* Current or previous psychotic disorder (e.g., schizophrenia spectrum disorder)
* Pregnancy and breastfeeding within the last eight weeks
* Unwilling to use a medically acceptable form of contraception throughout the study period (female of childbearing potential only)
* Prolonged QTc-time \>470 ms assessed with a 12-lead electrocardiogram.
* Regular use (\> 3 times per week) of sympathomimetic drugs (e.g., bronchodilators)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06036004
Study Brief:
Protocol Section:
NCT06036004