RecruitingPhase 1NCT04789148

Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency

Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency - A Pilot Study


Sponsor

Elizabeth Austen Lawson

Enrollment

40 participants

Start Date

Sep 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a randomized, double-blind, placebo-controlled crossover pilot study of single-dose intranasal oxytocin (6 IU and 24 IU) vs. placebo in adult men and women (aged 18 years and above) with arginine-vasopressin deficiency to evaluate the effect of oxytocin on anxiety, depression, and socioemotional functioning (Part A), with an optional randomized, double-blind, placebo-controlled 2-week repeated dose substudy of intranasal oxytocin 6 IU or placebo (Part B). Following a screening visit to determine eligibility, participants will return for three main study visits in Part A. During the main study visits, study participants will receive either oxytocin or placebo, followed by assessments of emotional behavior. In Part A, thirty participants will be equally randomized to one of six possible groups: 1. 6 IU oxytocin - 24 IU oxytocin - placebo 2. 6 IU oxytocin - placebo - 24 IU oxytocin 3. 24 IU oxytocin - 6 IU oxytocin - placebo 4. 24 IU oxytocin - placebo - 6 IU oxytocin 5. placebo - 6 IU oxytocin - 24 IU oxytocin 6. placebo - 24 IU oxytocin - 6 IU oxytocin Following completion of the Part A crossover portion of the study, in Part B participants may also choose to continue participation in an optional, randomized, double-blind, placebo-controlled substudy of intranasal oxytocin 6 IU or placebo three times a day for two weeks, followed by assessments of emotional behavior.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a nasal spray form of oxytocin (sometimes called the "bonding hormone") can improve quality of life and emotional well-being in people with arginine-vasopressin deficiency — a hormone disorder also known as central diabetes insipidus or cranial diabetes insipidus, where the body does not produce enough of a key hormone that regulates water balance. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of arginine-vasopressin deficiency - Your thyroid function and blood sodium levels are normal - Your hormone replacement therapy has been stable **You may NOT be eligible if...** - You have had an active substance use disorder in the past 6 months - You have a history of psychosis - You have had active suicidal thoughts or plans in the past month - You have recently changed any medications (within 4 weeks) Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIntranasal Oxytocin (IN-OXT)

6 IU single dose

DRUGIntranasal Oxytocin (IN-OXT)

IN-OXT 6 IU three times a day for 2 weeks

DRUGPlacebo

Intranasal placebo three times a day for 2 weeks

DRUGIntranasal Oxytocin (IN-OXT)

24 IU single dose

DRUGPlacebo

placebo single dose


Locations(1)

Massachusetts General Hospital, Neuroendocrine Unit

Boston, Massachusetts, United States

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NCT04789148


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