Clinical trial

Oxytocin Substitution Therapy in Patients With Central Diabetes Insipidus: a Double-blind Randomised Placebo-controlled Trial: the OxyTUTION Trial

Name

2023-01010; kt22ChristCrain

Description

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)

Trial arms

Trial start

2024-01-08

Estimated PCD

2026-10-01

Trial end

2026-10-01

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

Study Product Intervention: intranasal OXT

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.

Arms:

Control Intervention: placebo nasal spray

Size

112

Primary endpoint

Change in State-Trait Anxiety Inventory (STAI) questionnaire to assess general anxiety levels

Day 0, day 1, day 14, day 28

Change in EmBody/EmFace to assess recognition of facial and body expressions

Day 0, day 1, day 28

Eligibility 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. * Regular use (\> 3 times per week) of sympathomimetic drugs (e.g., bronchodilators)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'double-blind randomised placebo-controlled trial: participants will be randomly assigned 1:1 to receive either treatment with intranasal OXT or intranasal placebo', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Study participants, study team (i.e., study nurses, study physicians, study psychologists), and further outcome assessors will be blinded after assignment to interventions.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 112, 'type': 'ESTIMATED'}}

Updated at

2024-01-11

1 organization

1 product

1 indication

Organization

University Hospital Basel

Product

Intranasal OXT

Indication

Central Diabetes Insipidus (cDI)