RightFit
RecruitingPhase 1

Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 3 visits

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Following a screening visit to determine eligibility, participants will return for three main study visits in Part A."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether oxytocin nose spray affects anxiety, depression, emotions, and social behavior in adults with arginine-vasopressin deficiency, a lack of a hormone that helps control body water. Participants try two doses and a placebo, a spray with no study drug, at three visits. They may also join an optional two-week study of repeated doses.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have arginine-vasopressin deficiency.
  • Have normal thyroid hormone levels (FT4 or T4).
  • Have normal sodium (salt) levels in the blood.
  • Be on stable hormone replacement treatment.

Who can't join

  • A substance use disorder in the past 6 months, or a history of psychosis (trouble knowing what is real).
  • Suicidal behavior or thoughts with a plan or intent to act in the past month.
  • Medicine changes within 4 weeks before joining, or planned changes during the study.
  • Long-term nose blockage or another nose problem that could keep the spray from being given properly.
  • A history of heart disease. High blood pressure alone does not rule you out.
  • A history of stage 3 or worse kidney disease, or cirrhosis (liver scarring).
  • Pregnancy or breastfeeding within the past 8 weeks; or, for women who could become pregnant, not willing to use medically accepted birth control throughout the study.
  • Any serious illness, condition, medicine, or medical device that the study doctor thinks could affect participation, data collection, or safety.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

MA