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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 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. The trial reports 1 study location across 1 state.
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Intranasal Oxytocin (IN-OXT)
Study Locations (1)
Massachusetts
- Massachusetts General Hospital, Neuroendocrine Unit - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-09-10 |
| Est. Completion | 2026-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04789148
The ClinicalTrials.gov registry entry for NCT04789148 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Elizabeth Austen Lawson, which has 4 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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