Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency

Launched by ELIZABETH AUSTEN LAWSON · Mar 5, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of a hormone called oxytocin, delivered through the nose, in people with central diabetes insipidus. Central diabetes insipidus is a condition that affects the body's ability to manage water, leading to excessive thirst and urination. The study aims to see how oxytocin might help improve feelings of anxiety, depression, and social interactions in individuals aged 18 to 60 who have this condition. Participants will take either oxytocin or a placebo (a substance with no active ingredients) during different visits, and researchers will assess their emotional well-being afterward.

To be eligible for this study, participants must have central diabetes insipidus confirmed by medical tests and be stable on their hormone replacement therapy. However, individuals with a history of certain medical conditions, recent substance use, or who are currently pregnant or breastfeeding cannot join the trial. The study is not yet recruiting, but once it starts, participants can expect to attend several visits where they'll receive the treatment and complete assessments related to their emotional health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 and above
• • Arginine-vasopressin deficiency
• • Normal FT4 or T4
• • Normal serum/plasma sodium
• • Stable hormone replacement
• Exclusion Criteria:
• • Active substance use disorder within the last 6 months
• • History of psychosis
• • Suicidal behavior and/or active suicidal ideation with plan and/or intent, e.g., suicidal ideation of type 4 or type 5 as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS), in the last month
• • Medication changes within 4 weeks of enrollment or planned medication changes during the study
• • History of chronic nasal obstruction or local pathology in nostril pathway which, in the opinion of the investigator, would prevent appropriate nasal administration of the study drug.
• • History of cardiac disease, including arrhythmias, coronary heart disease, coronary artery spasms, valvular heart disease, hypertrophic cardiomyopathy (hypertension is not exclusionary)
• • History of chronic kidney disease stage III and above
• • History of liver cirrhosis
• • Pregnancy or breastfeeding within the last 8 weeks
• • Unwilling to use a medically acceptable form of contraception throughout the study period (female of child-bearing potential only)
• • Any significant illness, condition, drug or medical device that the Investigator determines could interfere with study participation, data collection, or safety