Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intranasal Oxytocin (IN-OXT), Intranasal Oxytocin (IN-OXT), Placebo, Intranasal Oxytocin (IN-OXT).
- Who it may be relevant to
- Registry conditions: Vasopressin Deficiency. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency - A Pilot Study
Overview
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.
Interventions
- Drug Intranasal Oxytocin (IN-OXT)
6 IU single dose - Drug Intranasal Oxytocin (IN-OXT)
IN-OXT 6 IU three times a day for 2 weeks - Drug Placebo
Intranasal placebo three times a day for 2 weeks - Drug Intranasal Oxytocin (IN-OXT)
24 IU single dose - Drug Placebo
placebo single dose
Primary outcome measures
- Dot-probe task - anxious behavior between low dose oxytocin and placebo [Time frame: 20 minutes following intervention at each main visit]
Secondary outcome measures (3)
- Dot-probe task - anxious behavior between all three interventions [Time frame: 20 minutes following intervention]
- Depressive behavior - probabilistic reward task between all three interventions [Time frame: 30 minutes following intervention at each main visit]
- Socioemotional functioning - Emotion recognition task between all three interventions [Time frame: 40 minutes following intervention at each main visit]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Massachusetts General Hospital, Neuroendocrine Unit — Boston
Identifiers
NCT: NCT04789148 · 2020P003071