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NCT04789148 · ClinicalTrials.gov registry record · Phase 1

Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency

A Phase 1 study of Vasopressin Deficiency, sponsored by Elizabeth Austen Lawson.

Recruiting
Registry status
Phase 1
Development phase
40
Enrollment target
1
Study location

NCT04789148: Recruiting Phase 1 study of Vasopressin Deficiency, sponsored by Elizabeth Austen Lawson.

NCT04789148 is a Phase 1 study of Vasopressin Deficiency that is actively recruiting participants, run by Elizabeth Austen Lawson. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04789148, a Phase 1 study of Vasopressin Deficiency, is actively recruiting participants, sponsored by Elizabeth Austen Lawson.

RECRUITING
Registry status
Phase 1
Development phase
40 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Difference in response times (in milliseconds) to dots appearing in the location of the previously shown negative versus the neutral face between 6 IU oxytocin vs placebo in the dot-probe task.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Intranasal Oxytocin (IN-OXT)

Study Locations (1)

Massachusetts

  • Massachusetts General Hospital, Neuroendocrine Unit - Boston

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2025-09-10
Est. Completion 2026-06
Phase Phase 1
Elizabeth Austen Lawson

4 total trials

What NCT04789148 shows while recruiting

NCT04789148 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).

The record links to 1 condition, with Vasopressin Deficiency appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04789148 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT04789148 about?

NCT04789148 is a clinical study titled "Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency". 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 socioemoti...

What is the current status of trial NCT04789148?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2025-09-10. Estimated completion is 2026-06.

What conditions does trial NCT04789148 study?

This clinical trial studies the following conditions: Vasopressin Deficiency.

What interventions are being tested in trial NCT04789148?

The interventions under investigation include: Placebo (DRUG), Intranasal Oxytocin (IN-OXT) (DRUG).

Who is sponsoring clinical trial NCT04789148?

This trial is sponsored by Elizabeth Austen Lawson, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04789148 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT04789148's enrollment target sits among peer trials

40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04789148, the US trial registry maintained by the National Library of Medicine. NCT04789148 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.