Oxytocin treatment for patients with central diabetes insipidus
Oxytocin Substitution Therapy in Patients With AVP Deficiency (Central Diabetes Insipidus)
This study is testing if a nasal spray of oxytocin can help people with central diabetes insipidus feel less anxious and improve their social interactions.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 3 sites (Berlin and 2 other locations) |
| Trial ID | NCT06036004 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with central diabetes insipidus who experience heightened anxiety or difficulties in emotional recognition.
Not a fit: Patients with active substance use disorders, psychotic disorders, or those who have recently participated in other investigational drug trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance the quality of life for patients with central diabetes insipidus by alleviating psychological symptoms.
How similar studies have performed: While the approach of using oxytocin for psychological symptoms in cDI is novel, similar studies have shown promise in other conditions related to socio-emotional functioning.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Berlin and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.