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RECRUITING
NCT06036004
PHASE2

Oxytocin Substitution Therapy in Patients With Central Diabetes Insipidus

Sponsor: University Hospital, Basel, Switzerland

View on ClinicalTrials.gov

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)

Official title: Oxytocin Substitution Therapy in Patients With AVP Deficiency (Central Diabetes Insipidus)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

112

Start Date

2024-01-08

Completion Date

2026-10

Last Updated

2026-01-05

Healthy Volunteers

No

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.

Locations (2)

Erasmus University Medical Center Rotterdam

Rotterdam, Netherlands

University Hospital Basel, Department of Endocrinology, Diabetes & Metabolism

Basel, Switzerland