Effects of Intranasal Oxytocin in Patients With Central Diabetes Insipidus

• Status: Not yet recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Elizabeth Austen Lawson
• Treatments: Oxytocin

Criteria

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