Clinical trial NCT04789148: Effects of Intranasal Oxytocin in Patients With Central Diabetes Insipidus
Official title: Effects of Intranasal Oxytocin in Patients With Central Diabetes Insipidus - A Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Central Diabetes Insipidus
Keywords: Hypopituitarism
posterior pituitary
oxytocin
psychopathology
anxiety
depressive symptoms
socioemotional functioning
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


Eligibility 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

Primary outcomes:
measure: Dot-probe task - anxious behavior between low dose oxytocin and placebo
timeFrame: 20 minutes following intervention at each main visit
Secondary outcomes:
measure: Dot-probe task - anxious behavior between all three interventions
timeFrame: 20 minutes following intervention
measure: Depressive behavior - probabilistic reward task between all three interventions
timeFrame: 30 minutes following intervention at each main visit
measure: Socioemotional functioning - Emotion recognition task between all three interventions
timeFrame: 40 minutes following intervention at each main visit
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital, Neuroendocrine Unit
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Elizabeth A Lawson, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References: