Actively Recruiting
Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency - A Pilot Study
Led by Elizabeth Austen Lawson · Updated on 2025-09-16
40
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the effects of intranasal oxytocin on anxiety, depression, and social-emotional functioning in adults aged 18 years and older who have arginine-vasopressin deficiency. This is a randomized, double-blind, placebo-controlled pilot study designed to explore how different doses of oxytocin impact these psychological and behavioral outcomes. The study is led by Elizabeth Austen Lawson and aims to better understand oxytocin's role in people with this condition. Participants first complete a screening visit to confirm eligibility. In Part A, they attend three main visits where they receive single doses of intranasal oxytocin at 6 IU, 24 IU, or placebo in varying orders across six groups. After Part A, participants may opt to join Part B, a two-week substudy where they receive either 6 IU of intranasal oxytocin or placebo three times daily, also in a randomized, double-blind design. During the visits, participants undergo assessments measuring anxious behavior using a dot-probe task, depressive behavior with a probabilistic reward task, and socioemotional functioning through an emotion recognition task at specific times after dosing. The study monitors effects shortly after each intervention, with primary outcomes measured 20 minutes post-dose. The total study duration varies depending on participation in Part B, with careful monitoring of emotional and behavioral changes throughout.
CONDITIONS
Brief 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
- Diagnosis of arginine-vasopressin deficiency
- Normal thyroid hormone levels (FT4 or T4)
- Normal serum or plasma sodium levels
- Stable hormone replacement therapy
You will not qualify if you...
- Active substance use disorder within the last 6 months
- History of psychosis
- Suicidal behavior or active suicidal thoughts with plan or intent in the last month
- Medication changes within 4 weeks before enrollment or planned during the study
- Chronic nasal obstruction or nasal pathway issues preventing nasal drug administration
- History of cardiac disease including arrhythmias, coronary heart disease, spasms, valvular disease, or hypertrophic cardiomyopathy
- Chronic kidney disease stage III or higher
- History of liver cirrhosis
- Pregnancy or breastfeeding within the last 8 weeks
- Unwillingness to use acceptable contraception during the study (for females of childbearing potential)
- Any significant illness or condition that could interfere with participation or safety as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 main visits over several weeks
Participants receive different doses of intranasal oxytocin or placebo across multiple visits in a crossover design.
3 main visits with single-dose administration at each visit
Duration - 14 days
Participants receive intranasal oxytocin or placebo three times a day for 14 days as part of extended dosing periods.
Daily dosing with assessments during and after the treatment period
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
E
Elisa Asanza, MSN, MPH
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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