Effects of Intranasal Oxytocin in Patients With Central Diabetes Insipidus

Elizabeth Austen Lawson

Status and phase: Not yet enrolling; Phase 1

Conditions: Central Diabetes Insipidus

Treatments: Drug: Oxytocin nasal spray

Study type: Interventional

Funder types: Other

Identifiers

NCT04789148

2020P003071

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 6 patient groups

4 IU oxytocin - 24 IU oxytocin - placebo

Experimental group

Description:

Main visit 1: 4 IU intranasal oxytocin; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: intranasal placebo

Treatment:

Drug: Oxytocin nasal spray

4 IU oxytocin - placebo - 24 IU oxytocin

Experimental group

Description:

Main visit 1: 4 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 24 IU intranasal oxytocin

Treatment:

Drug: Oxytocin nasal spray

24 IU oxytocin - 4 IU oxytocin - placebo

Experimental group

Description:

Main visit 1: 24 IU intranasal oxytocin; Main visit 2: 4 IU intranasal oxytocin; Main visit 3: intranasal placebo

Treatment:

Drug: Oxytocin nasal spray

24 IU oxytocin - placebo - 4 IU oxytocin

Experimental group

Description:

Main visit 1: 24 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 4 IU intranasal oxytocin

Treatment:

Drug: Oxytocin nasal spray

Placebo - 4 IU oxytocin - 24 IU oxytocin

Experimental group

Description:

Main visit 1: intranasal placebo; Main visit 2: 4 IU intranasal oxytocin; Main visit 3: 24 IU intranasal oxytocin

Treatment:

Drug: Oxytocin nasal spray

Placebo - 24 IU oxytocin - 4 IU oxytocin

Experimental group

Description:

Main visit 1: intranasal placebo; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: 4 IU intranasal oxytocin

Treatment:

Drug: Oxytocin nasal spray