Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06036004

Oxytocin Substitution Therapy in Patients With Central Diabetes Insipidus

Led by University Hospital, Basel, Switzerland · Updated on 2026-05-06

112

Participants Needed

3

Research Sites

142 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This randomized, placebo-controlled, double-blind trial aims to investigate intranasal OXT as a novel therapeutical option in central diabetes insipidus (cDI) to improve psychological symptoms and socio-emotional functioning. Optionally, patients can present for additional assessments in sub-studies: * fMRI sub-study at day 14 (± 2 days) (one additional visit) * Social-stress sub-study at day 14 (± 2 days) (one additional visit)

CONDITIONS

Official Title

Oxytocin Substitution Therapy in Patients With Central Diabetes Insipidus

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients with a confirmed diagnosis of central diabetes insipidus based on accepted criteria
  • Heightened anxiety levels (STAI - Trait subscale 29e 39 score points) or alexithymia levels (TAS-20 total 29e 52 score points)
  • Stable hormone replacement therapy for at least three months with desmopressin and, if needed, other hormone substitutions
Not Eligible

You will not qualify if you...

  • Participation in a trial with investigational drugs within 30 days
  • Active substance use disorder within the last six months
  • Consumption of alcoholic beverages more than 15 drinks per week
  • Current or previous psychotic disorder such as schizophrenia
  • Pregnancy or breastfeeding within the last eight weeks
  • Unwillingness to use medically acceptable contraception during the study (for women able to become pregnant)
  • Prolonged QTc-time greater than 470 ms on electrocardiogram

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Charité University Medical Center Berlin

Berlin, Germany, 10117

Actively Recruiting

2

Erasmus University Medical Center Rotterdam

Rotterdam, Netherlands, 3015

Actively Recruiting

3

University Hospital Basel, Department of Endocrinology, Diabetes & Metabolism

Basel, Switzerland, 4031

Actively Recruiting

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Research Team

M

Mirjam Christ-Crain, Prof. Dr. med.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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