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Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency

RecruitingPhase 1Ages 18 Years - anyAllElizabeth Austen Lawson
NCT04789148 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 oxytoc

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 18 and above * Arginine-vasopressin deficiency * Normal FT4 * 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 that could interfere with study procedures or endpoints per study physician discretion * 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 clinically relevant ventricular arrhythmias, coronary heart disease, and hypertrophic cardiomyopathy * 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
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What it tests

  • Intranasal Oxytocin (IN-OXT) 6 IU single dose
  • Intranasal Oxytocin (IN-OXT) 6 IU repeat dose
  • Placebo repeat dose
  • Intranasal Oxytocin (IN-OXT) 24 IU single dose
  • Placebo single dose
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Where

1 site
Massachusetts General Hospital, Neuroendocrine Unit
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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