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Oxytocin substitution therapy in patients with AVP deficiency (central diabetes insipidus): a double-blind randomised placebo-controlled trial - the OxyTUTION trial

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516813-19-00
Acronym
OxyTUTION
Enrollment
70
Registered
2025-01-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

central diabetes insipidus

Brief summary

Trait anxiety level and correct classifications of facial & body expression after 28 (+/-2) days of treatment assessed with the STAI-T and the EmBody/EmFace Task. ▪ The STAI-T comprises 20 items scoring 1-4 points each. ▪ The EmBody/EmFace comprises 84 items scoring correct or incorrect each.

Detailed description

Emotion recognition and empathy, Hormonal and subjective response to psychological stress, Amygdala and subjective response in the functional MRI scan, Further psychological outcomes, Metabolic outcomes, Objective assessment of a close third person, Safety outcome

Interventions

DRUGOXYTOCIN
DRUGThe placebo nasal spray will be identical in volume
DRUGlabelling but not container system
DRUGand other features. The placebo will contain 0.9% sodium chloride and no OXT.

Sponsors

Universitaetsspital Basel
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Trait anxiety level and correct classifications of facial & body expression after 28 (+/-2) days of treatment assessed with the STAI-T and the EmBody/EmFace Task. ▪ The STAI-T comprises 20 items scoring 1-4 points each. ▪ The EmBody/EmFace comprises 84 items scoring correct or incorrect each.

Secondary

MeasureTime frame
Emotion recognition and empathy, Hormonal and subjective response to psychological stress, Amygdala and subjective response in the functional MRI scan, Further psychological outcomes, Metabolic outcomes, Objective assessment of a close third person, Safety outcome

Countries

Germany, Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026