Effects of Intranasal Oxytocin in Patients With Central Diabetes Insipidus

Phase 1

Not yet recruiting

• Conditions: Central Diabetes Insipidus
• Interventions: Drug: Oxytocin nasal spray

• Registration Number: NCT04789148
• Lead Sponsor: Elizabeth Austen Lawson

Brief Summary

This is a randomized, double-blind, placebo-controlled crossover pilot study of single-dose intranasal oxytocin (4 IU and 24 IU) in 18-60-year-old men and women with central diabetes insipidus to evaluate the effect of oxytocin on anxiety, depression and socioemotional functioning.

Following a screening visit to determine eligibility, participants will return for three main study visits. During the main study visits, study participants will receive either oxytocin or placebo, followed by assessments of emotional behavior.

Thirty participants will be equally randomized to one of six possible drug orders:

1. 4 IU oxytocin - 24 IU oxytocin - placebo

2. 4 IU oxytocin - placebo - 24 IU oxytocin

3. 24 IU oxytocin - 4 IU oxytocin - placebo

4. 24 IU oxytocin - placebo - 4 IU oxytocin

5. placebo - 4 IU oxytocin - 24 IU oxytocin

6. placebo - 24 IU oxytocin - 4 IU oxytocin

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-05
• Study First Submitted QC: 2021-03-05
• Study First Posted: 2021-03-09
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-30
• Last Update Posted: 2022-12-01
• Study Start: 2023-06
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Central diabetes insipidus (based on routine clinical practice, e.g., clinical symptoms, serum and urinary sodium and osmolality levels or the water deprivation test)
• Normal FT4 or T4
• Stable hormone replacement (no change in dose of hormone replacement in six weeks prior to baseline)

Exclusion Criteria

• Active substance use disorder within the last 6 months
• History of psychosis
• Current suicidal ideation
• Medication changes within 4 weeks of enrollment or during the study
• History of cardiac disease, including arrhythmias, coronary heart disease, coronary artery spasms, valvular heart disease, hypertrophic cardiomyopathy (hypertension is not exclusionary)
• Hyponatremia
• Creatinine >1.5mg/dL.
• ALT or AST >2.5x upper limit of normal
• Hematocrit less than 2% below the norm
• Pregnancy or breastfeeding within the last 8 weeks
• Unwilling to use a medically acceptable form of contraception throughout the study period (female of child-bearing potential only)
• Received an investigational drug or medical device in the past 30 days or within 5 half-lives of main study visit or be concurrently enrolled in another investigational product clinical trial.
• Any significant illness or condition that the Investigator determines could interfere with study participation, data collection, or safety

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
4 IU oxytocin - 24 IU oxytocin - placebo	Oxytocin nasal spray	Main visit 1: 4 IU intranasal oxytocin; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: intranasal placebo
24 IU oxytocin - placebo - 4 IU oxytocin	Oxytocin nasal spray	Main visit 1: 24 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 4 IU intranasal oxytocin
4 IU oxytocin - placebo - 24 IU oxytocin	Oxytocin nasal spray	Main visit 1: 4 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 24 IU intranasal oxytocin
24 IU oxytocin - 4 IU oxytocin - placebo	Oxytocin nasal spray	Main visit 1: 24 IU intranasal oxytocin; Main visit 2: 4 IU intranasal oxytocin; Main visit 3: intranasal placebo
Placebo - 4 IU oxytocin - 24 IU oxytocin	Oxytocin nasal spray	Main visit 1: intranasal placebo; Main visit 2: 4 IU intranasal oxytocin; Main visit 3: 24 IU intranasal oxytocin
Placebo - 24 IU oxytocin - 4 IU oxytocin	Oxytocin nasal spray	Main visit 1: intranasal placebo; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: 4 IU intranasal oxytocin

Primary Outcome Measures

Name	Time	Method
Dot-probe task - anxious behavior between low dose oxytocin and placebo	20 minutes following intervention at each main visit	Difference in response times (in milliseconds) to dots appearing in the location of the previously shown negative versus the neutral face between 4 IU oxytocin vs placebo in the dot-probe task.

Secondary Outcome Measures

Name	Time	Method
Depressive behavior - probabilistic reward task between all three interventions	30 minutes following intervention at each main visit	Response bias developed toward the more frequently reinforced alternative between 4 IU oxytocin, 24 IU oxytocin, and placebo in the probabilistic reward task.
Dot-probe task - anxious behavior between all three interventions	20 minutes following intervention	Difference in response time (in milliseconds) to dots appearing in the location of the previously shown negative versus neutral face between 4 IU oxytocin, 24 IU oxytocin, and placebo in the dot-probe task.
Socioemotional functioning - Emotion recognition task between all three interventions	40 minutes following intervention at each main visit	Accuracy in identifying correct emotion between 4 IU oxytocin, 24 IU oxytocin, and placebo in the emotion recognition task.

Trial Locations

Locations (1)

Massachusetts General Hospital, Neuroendocrine Unit; 🇺🇸 Boston, Massachusetts, United States