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Oxytocin Substitution Therapy in Patients With Central Diabetes Insipidus

NCT06036004 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2026-05-06

No results posted yet for this study

Summary

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

  • Central Diabetes Insipidus (cDI)

Interventions

DRUG

Intranasal OXT

Syntocinon® contains the synthesized peptide OXT in a solution formulated to promote absorption through the nasal mucosa. Additional ingredients are E216 (propyl-4-hydroxybenzoate), E218 (methyl-4-hydroxybenzoate), and chlorobutanol hemihydrate. One bottle contains 5 ml, i.e., 200 IU of OXT in total. Each 0.1 ml nasal insulation delivers 4 IU of oxytocin. OXT (24 IU twice daily) is given for 28 (± 2) days of treatment.

OTHER

Placebo nasal spray

The placebo will contain no OXT but, otherwise, be identical to the intranasal OXT product with respect to the other ingredients. Placebo is given twice daily for 28 (± 2) days of treatment.

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Mirjam Christ-Crain, Prof. Dr. med. · University Hospital Basel, Department of Endocrinology, Diabetes & Metabolism

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-08
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Germany
  • Netherlands
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06036004 on ClinicalTrials.gov