Recruiting
Phase 1

Oxytocin

Sponsor:

Elizabeth Austen Lawson

Code:

NCT04789148

Conditions

Vasopressin Deficiency

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intranasal Oxytocin (IN-OXT)

Intranasal Oxytocin (IN-OXT)

Placebo

Intranasal Oxytocin (IN-OXT)

Placebo

Study Details

Brief summary:

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.

Conditions

Vasopressin Deficiency

Study ID

NCT04789148

Start date

Sep 10, 2025

Status verified date

Sep, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Part A Arm 1

Main visit 1: 6 IU intranasal oxytocin; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: intranasal placebo

experimental: Part A Arm 2

Main visit 1: 6 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 24 IU intranasal oxytocin

experimental: Part A Arm 3

Main visit 1: 24 IU intranasal oxytocin; Main visit 2: 6 IU intranasal oxytocin; Main visit 3: intranasal placebo

experimental: Part A Arm 4

Main visit 1: 24 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 6 IU intranasal oxytocin

experimental: Part A Arm 5

Main visit 1: intranasal placebo; Main visit 2: 6 IU intranasal oxytocin; Main visit 3: 24 IU intranasal oxytocin

experimental: Part A Arm 6

Main visit 1: intranasal placebo; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: 6 IU intranasal oxytocin

active comparator: Part B Arm 1

Intranasal oxytocin 6 IU three times a day for 14 days

experimental: Part B Arm 2

Intranasal placebo three times a day for 14 days

Interventions

Intranasal Oxytocin (IN-OXT)

6 IU single dose

Intranasal Oxytocin (IN-OXT)

IN-OXT 6 IU three times a day for 2 weeks

Placebo

Intranasal placebo three times a day for 2 weeks

Intranasal Oxytocin (IN-OXT)

24 IU single dose

Placebo

placebo single dose

Primary outcome measure

  • Dot-probe task - anxious behavior between low dose oxytocin and placebo [ Time Frame: 20 minutes following intervention at each main visit ]

Central Contacts and Locations

Central contacts

Francesca Galbiati, MD

(617) 726-3870FGALBIATI@BWH.HARVARD.EDU

Elisa Asanza, MSN, MPH

617-726-3870easanza@mgh.harvard.edu

Locations

Massachusetts General Hospital, Neuroendocrine Unit

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Francesca Galbiati, MD

(617) 726-3870fgalbiati@bwh.harvard.edu

Elisa Asanza, MSN, MPH

617-726-3870easanza@mgh.harvard.edu

More Information

Sponsor

Elizabeth Austen Lawson

Last update posted

Jul 23, 2026

Last verified

Sep, 2025

Keywords

  • Hypopituitarism
  • posterior pituitary
  • oxytocin
  • psychopathology
  • anxiety
  • depressive symptoms
  • socioemotional functioning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Elizabeth Austen Lawson on 2026-07-23.