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Hormone Therapy

Intranasal Oxytocin for Central Diabetes Insipidus

Phase 1
Waitlist Available
Led By Elizabeth A Lawson, MD, MMSc
Research Sponsored by Elizabeth Austen Lawson
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Central diabetes insipidus (based on routine clinical practice, e.g., clinical symptoms, serum and urinary sodium and osmolality levels or the water deprivation test)
Be between 18 and 65 years old
Must not have
Current suicidal ideation
Medication changes within 4 weeks of enrollment or during the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 40 minutes following intervention at each main visit
Awards & highlights

Summary

This trial will evaluate the effect of oxytocin on anxiety, depression and socioemotional functioning in men and women with central diabetes insipidus.

Who is the study for?
This trial is for men and women aged 18-60 with central diabetes insipidus who have had stable hormone replacement therapy without dose changes for six weeks. Participants must not be pregnant, breastfeeding, or have a history of psychosis or substance abuse recently. They should also not be on any investigational drugs or have significant illnesses that could affect the study.
What is being tested?
The trial tests how intranasal oxytocin (4 IU and 24 IU doses) affects anxiety, depression, and socioemotional functioning in patients with central diabetes insipidus. It's randomized and double-blind, meaning neither researchers nor participants know who gets the real treatment versus placebo during the study.
What are the potential side effects?
While specific side effects are not listed here, intranasal oxytocin can sometimes cause nasal irritation or discomfort, headaches, possible emotional changes due to its effects on mood regulation systems in the brain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with central diabetes insipidus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently experiencing thoughts of harming myself.
Select...
I haven't changed my medications in the last 4 weeks and won't during the study.
Select...
I have a history of heart disease but not high blood pressure alone.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~40 minutes following intervention at each main visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and 40 minutes following intervention at each main visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dot-probe task - anxious behavior between low dose oxytocin and placebo
Secondary study objectives
Depressive behavior - probabilistic reward task between all three interventions
Dot-probe task - anxious behavior between all three interventions
Socioemotional functioning - Emotion recognition task between all three interventions

Side effects data

From 2019 Phase 1 & 2 trial • 23 Patients • NCT03119610
58%
Dizziness
42%
Allergic Rhinitis
42%
Nausea
33%
Headache
17%
Nasal Irritation
17%
Sore Throat
17%
Lightheaded
8%
Neck Pain
8%
Bruise related to biopsy
8%
Confusion
8%
Skin Rash
8%
Sinus Disorder
8%
Anorexia
8%
Throat itching
8%
Muscle Aches
8%
Upset stomach
8%
Migraine
8%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Nasal Spray
Oxytocin Nasal Spray

Trial Design

6Treatment groups
Experimental Treatment
Group I: Placebo - 4 IU oxytocin - 24 IU oxytocinExperimental Treatment1 Intervention
Main visit 1: intranasal placebo; Main visit 2: 4 IU intranasal oxytocin; Main visit 3: 24 IU intranasal oxytocin
Group II: Placebo - 24 IU oxytocin - 4 IU oxytocinExperimental Treatment1 Intervention
Main visit 1: intranasal placebo; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: 4 IU intranasal oxytocin
Group III: 4 IU oxytocin - placebo - 24 IU oxytocinExperimental Treatment1 Intervention
Main visit 1: 4 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 24 IU intranasal oxytocin
Group IV: 4 IU oxytocin - 24 IU oxytocin - placeboExperimental Treatment1 Intervention
Main visit 1: 4 IU intranasal oxytocin; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: intranasal placebo
Group V: 24 IU oxytocin - placebo - 4 IU oxytocinExperimental Treatment1 Intervention
Main visit 1: 24 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 4 IU intranasal oxytocin
Group VI: 24 IU oxytocin - 4 IU oxytocin - placeboExperimental Treatment1 Intervention
Main visit 1: 24 IU intranasal oxytocin; Main visit 2: 4 IU intranasal oxytocin; Main visit 3: intranasal placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxytocin nasal spray
2016
Completed Phase 4
~1480

Find a Location

Who is running the clinical trial?

Elizabeth Austen LawsonLead Sponsor
2 Previous Clinical Trials
78 Total Patients Enrolled
Elizabeth A Lawson, MD, MMScPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
56 Total Patients Enrolled

Media Library

Oxytocin nasal spray (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04789148 — Phase 1
Central Diabetes Insipidus Research Study Groups: 4 IU oxytocin - 24 IU oxytocin - placebo, 4 IU oxytocin - placebo - 24 IU oxytocin, 24 IU oxytocin - 4 IU oxytocin - placebo, 24 IU oxytocin - placebo - 4 IU oxytocin, Placebo - 4 IU oxytocin - 24 IU oxytocin, Placebo - 24 IU oxytocin - 4 IU oxytocin
Central Diabetes Insipidus Clinical Trial 2023: Oxytocin nasal spray Highlights & Side Effects. Trial Name: NCT04789148 — Phase 1
Oxytocin nasal spray (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04789148 — Phase 1
~11 spots leftby Jun 2025
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