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

Who is this study for? Patients with central diabetes insipidus
What treatments are being studied? Oxytocin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 and above

• Arginine-vasopressin deficiency

• Normal FT4 or T4

• Normal serum/plasma sodium

• Stable hormone replacement

Locations
United States
Massachusetts
Massachusetts General Hospital, Neuroendocrine Unit
RECRUITING
Boston
Contact Information
Primary
Francesca Galbiati, MD
FGALBIATI@BWH.HARVARD.EDU
(617) 726-3870
Backup
Elisa Asanza, MSN, MPH
easanza@mgh.harvard.edu
617-726-3870
Time Frame
Start Date: 2025-09-10
Estimated Completion Date: 2026-06
Participants
Target number of participants: 40
Treatments
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
Sponsors
Collaborators: Tonix Pharmaceuticals, Inc.
Leads: Elizabeth Austen Lawson

This content was sourced from clinicaltrials.gov