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

Elizabeth Austen Lawson2 个研究点分布在 1 个国家目标入组 40 人开始时间: 2025年9月10日最近更新: 2026年7月23日

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方
入组人数: 40
试验地点: 2
主要终点: Dot-probe task - anxious behavior between low dose oxytocin and placebo

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

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:

6 IU oxytocin - 24 IU oxytocin - placebo
6 IU oxytocin - placebo - 24 IU oxytocin
24 IU oxytocin - 6 IU oxytocin - placebo
24 IU oxytocin - placebo - 6 IU oxytocin
placebo - 6 IU oxytocin - 24 IU oxytocin
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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Basic Science
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age 18 and above
•Arginine-vasopressin deficiency
•Normal FT4 or T4
•Normal serum/plasma sodium
•Stable hormone replacement

排除标准

•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

研究组 & 干预措施

Part A Arm 1

Experimental

Main visit 1: 6 IU intranasal oxytocin; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: intranasal placebo