Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency

Purpose

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.

Condition

  • Vasopressin Deficiency

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Randomized, double-blind, placebo-controlled, single dose crossover study evaluating 2 different dose levels of intranasal oxytocin vs placebo (Part A), followed by Part B, an optional 2-week randomized, double-blind, placebo-controlled substudy investigating intranasal oxytocin 6 IU vs. placebo three times a day.
Primary Purpose
Basic Science
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part A Arm 1 		Main visit 1: 6 IU intranasal oxytocin; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: intranasal placebo
  • 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
Experimental
Part A Arm 2 		Main visit 1: 6 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 24 IU intranasal oxytocin
  • 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
Experimental
Part A Arm 3 		Main visit 1: 24 IU intranasal oxytocin; Main visit 2: 6 IU intranasal oxytocin; Main visit 3: intranasal placebo
  • 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
Experimental
Part A Arm 4 		Main visit 1: 24 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 6 IU intranasal oxytocin
  • 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
Experimental
Part A Arm 5 		Main visit 1: intranasal placebo; Main visit 2: 6 IU intranasal oxytocin; Main visit 3: 24 IU intranasal oxytocin
  • 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
Experimental
Part A Arm 6 		Main visit 1: intranasal placebo; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: 6 IU intranasal oxytocin
  • 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
Active Comparator
Part B Arm 1 		Intranasal oxytocin 6 IU three times a day for 14 days
  • Drug: Intranasal Oxytocin (IN-OXT)
    24 IU single dose
Experimental
Part B Arm 2 		Intranasal placebo three times a day for 14 days
  • Drug: Placebo
    placebo single dose

Recruiting Locations

Massachusetts General Hospital, Neuroendocrine Unit
Boston 4930956, Massachusetts 6254926 02114
Contact:
Francesca Galbiati, MD
(617) 726-3870
fgalbiati@bwh.harvard.edu

More Details

Status
Recruiting
Sponsor
Elizabeth Austen Lawson

Study Contact

Francesca Galbiati, MD
(617) 726-3870
FGALBIATI@BWH.HARVARD.EDU