Actively Recruiting
Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency
Led by Elizabeth Austen Lawson · Updated on 2025-09-16
40
Participants Needed
1
Research Sites
37 weeks
Total Duration
On this page
Sponsors
E
Elizabeth Austen Lawson
Lead Sponsor
T
Tonix Pharmaceuticals, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 and above
- Arginine-vasopressin deficiency
- Normal FT4 or T4
- Normal serum/plasma sodium
- Stable hormone replacement
You will not qualify if you...
- Active substance use disorder within the last 6 months
- History of psychosis
- Suicidal behavior and/or active suicidal ideation with plan and/or intent 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 preventing nasal administration of the study drug
- History of cardiac disease including arrhythmias, coronary heart disease, coronary artery spasms, valvular heart disease, hypertrophic cardiomyopathy
- History of chronic kidney disease stage III and above
- History of liver cirrhosis
- Pregnancy or breastfeeding within the last 8 weeks
- Unwillingness to use medically acceptable contraception during the study (for females of child-bearing potential)
- Any significant illness or condition that could interfere with participation or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital, Neuroendocrine Unit
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
F
Francesca Galbiati, MD
CONTACT
E
Elisa Asanza, MSN, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
8
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