Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorElizabeth Austen Lawson

About this trial

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 criteria

Qualifiers

Age 18 and above

Arginine-vasopressin deficiency

Normal FT4 or T4

Normal serum/plasma sodium

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

40 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Sponsors and collaborators

Elizabeth Austen Lawson

Lead sponsor

Massachusetts General Hospital

Sponsor institution

Tonix Pharmaceuticals, Inc.

Collaborator