Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency

Conditions

• Vasopressin Deficiency

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Intranasal Oxytocin (IN-OXT) — DRUG
  6 IU single dose
• Intranasal Oxytocin (IN-OXT) — DRUG
  IN-OXT 6 IU three times a day for 2 weeks
• Placebo — DRUG
  Intranasal placebo three times a day for 2 weeks
• Intranasal Oxytocin (IN-OXT) — DRUG
  24 IU single dose
• Placebo — DRUG
  placebo single dose

Study Details

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.

Key Dates

Start date

Sep 10, 2025

Status verified

Sep 2025

Primary completion

Jun 30, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

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

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

• Francesca Galbiati, MD
  (617) 726-3870
  [email protected]
• Elisa Asanza, MSN, MPH
  617-726-3870
  [email protected]

Locations (1)

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