Oxytocin treatment for patients with central diabetes insipidus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled, double-blind trial investigates the use of intranasal oxytocin (OXT) as a potential treatment for psychological symptoms in patients with central diabetes insipidus (cDI). The study aims to address the residual psychological issues, such as anxiety and impaired social functioning, that persist despite conventional treatment with desmopressin. Participants will receive either OXT or a placebo and may also take part in optional sub-studies involving fMRI and social stress assessments. The goal is to determine if OXT can improve socio-emotional functioning in these patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Charité University Medical Center Berlin
  Berlin, Germany Recruiting
• Erasmus University Medical Center Rotterdam
  Rotterdam, Netherlands Recruiting
• University Hospital Basel, Department of Endocrinology, Diabetes & Metabolism
  Basel, Switzerland Recruiting

Study contacts

• Principal investigator: Mirjam Christ-Crain, Prof. Dr. med. — University Hospital Basel, Department of Endocrinology, Diabetes & Metabolism
• Study coordinator: Mirjam Christ-Crain, Prof. Dr. med.
• Email: mirjam.christ-crain@ubs.ch
• Phone: +41 61 328 70 80

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Intranasal oxytocin for sexual well‑being in people with arginine vasopressin deficiency and matched healthy adults

  This trial will test whether a nasal oxytocin spray can improve sexual well‑being, arousal, intimacy and related emotions in adults with arginine vasopressin deficiency and in matched healthy adults.

  Recruiting Phase 2 University Hospital, Basel, Switzerland · Basel · NCT06808516

• Effects of low-dose MDMA on oxytocin levels in patients with vasopressin deficiency and healthy controls

  This study is testing whether low-dose MDMA can increase oxytocin levels in people with a vasopressin deficiency and healthy individuals to see how it affects them differently.

  Recruiting University Hospital, Basel, Switzerland · Basel · NCT06789705

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.