Intranasal oxytocin for adults with arginine-vasopressin deficiency
Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency - A Pilot Study
This will test whether a single dose (6 IU or 24 IU) or a short 2-week course of intranasal oxytocin can reduce anxiety and depression and improve social-emotional functioning in adults with vasopressin deficiency.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04789148 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled crossover pilot enrolls 30 adults with arginine-vasopressin deficiency to receive single doses of intranasal oxytocin (6 IU and 24 IU) and placebo across three visits (Part A), with an optional randomized, double-blind, placebo-controlled 2-week repeated-dose substudy of 6 IU oxytocin (Part B). Participants are assigned to one of six dosing sequences so each person receives each intervention once across visits, and emotional behavior, anxiety, and depression measures are collected after dosing. Eligibility requires stable hormone replacement, normal thyroid function and sodium levels, and excludes active substance use disorder, psychosis, significant cardiac or advanced kidney disease, or nasal conditions that would prevent nasal administration. All visits are conducted at the Neuroendocrine Unit at Massachusetts General Hospital under double-blind conditions to compare short-term behavioral effects of oxytocin versus placebo.
Who should consider this trial
Good fit: Adults (age 18+) with confirmed arginine-vasopressin deficiency who have stable hormone replacement, normal thyroid function and sodium levels, and no recent medication changes are ideal candidates.
Not a fit: People with recent active substance use disorder, history of psychosis or severe suicidal ideation, significant cardiac disease, advanced kidney disease, or nasal obstruction are unlikely to be eligible or to benefit from this intervention.
Why it matters
Potential benefit: If effective, oxytocin could offer a short-term option to reduce anxiety and depressive symptoms and improve social functioning in people with vasopressin deficiency.
How similar studies have performed: Prior intranasal oxytocin research in psychiatric and social-function domains has shown mixed results, and application specifically in vasopressin deficiency is largely novel and unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 and above * Arginine-vasopressin deficiency * Normal FT4 or T4 * 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 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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital, Neuroendocrine Unit — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Elizabeth A Lawson, MD, MMSc — Massachusetts General Hospital
- Study coordinator: Francesca Galbiati, MD
- Email: FGALBIATI@BWH.HARVARD.EDU
- Phone: (617) 726-3870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.