40 Participants Needed

Intranasal Oxytocin for Central Diabetes Insipidus

CO
EA
FG
EA
Overseen ByElisa Asanza, MSN, MPH
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Elizabeth Austen Lawson
Must be taking: Hormone replacement
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how an oxytocin nasal spray might help with anxiety, depression, and social skills in people with central diabetes insipidus, a condition where the body poorly manages water due to a lack of the hormone arginine-vasopressin. Participants will try different doses of the spray or a placebo to assess its effects on emotions and behavior. Those who struggle with water balance due to this hormone deficiency and are on stable hormone treatment might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial requires that there be no medication changes within 4 weeks before joining or during the study, so you may need to stop or adjust your current medications before enrolling.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that oxytocin nasal spray is generally safe for people, having been tested on both children and adults. Most experience only mild side effects, such as a stuffy or irritated nose. In some studies, participants used oxytocin for several weeks without major problems. For instance, one individual used 6 IU of oxytocin nasal spray daily for over ten weeks and continued for 38 weeks with another medication without significant issues. Overall, current evidence suggests that oxytocin nasal spray is well-tolerated.12345

Why do researchers think this study treatment might be promising for diabetes insipidus?

Researchers are excited about the intranasal oxytocin treatment for central diabetes insipidus because it offers a novel delivery method compared to the typical oral or injectable options like desmopressin. This nasal spray could potentially provide a more convenient and non-invasive option for patients, enhancing adherence to treatment. Oxytocin, the active ingredient, might also influence water balance and urine concentration differently, giving hope for better symptom management.

What evidence suggests that intranasal oxytocin might be an effective treatment for central diabetes insipidus?

Research has shown that oxytocin nasal spray might help manage anxiety and improve emotion recognition in people with central diabetes insipidus. One study found that oxytocin could enhance emotional behavior, a key goal of this treatment. Although limited data exists on its effectiveness specifically for central diabetes insipidus, oxytocin is known to aid in social connections and emotion management. Early findings suggest it might reduce anxiety and improve social and emotional functioning, but further research is needed to confirm these effects. This trial examines various dosages and sequences of oxytocin nasal spray to determine its potential benefits for patients with central diabetes insipidus, as oxytocin may mimic certain natural hormones these patients lack.12345

Who Is on the Research Team?

EA

Elizabeth A Lawson, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with central diabetes insipidus.
Your thyroid hormone levels are within the normal range.
My hormone replacement dose has been stable for the last six weeks.

Exclusion Criteria

Any significant illness or condition that the Investigator determines could interfere with study participation, data collection, or safety
You have a history of severe mental illness that includes losing touch with reality.
Pregnancy or breastfeeding within the last 8 weeks
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants receive intranasal oxytocin or placebo during three main study visits, followed by assessments of emotional behavior

3 visits
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Oxytocin nasal spray
Trial Overview 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.
How Is the Trial Designed?
8Treatment groups
Experimental Treatment
Active Control
Group I: Part B Arm 2Experimental Treatment1 Intervention
Group II: Part A Arm 6Experimental Treatment2 Interventions
Group III: Part A Arm 5Experimental Treatment2 Interventions
Group IV: Part A Arm 4Experimental Treatment2 Interventions
Group V: Part A Arm 3Experimental Treatment2 Interventions
Group VI: Part A Arm 2Experimental Treatment2 Interventions
Group VII: Part A Arm 1Experimental Treatment2 Interventions
Group VIII: Part B Arm 1Active Control1 Intervention

Oxytocin nasal spray is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Pitocin for:
🇪🇺
Approved in European Union as Syntocinon for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Elizabeth Austen Lawson

Lead Sponsor

Trials
4
Recruited
200+

Tonix Pharmaceuticals, Inc.

Industry Sponsor

Trials
31
Recruited
4,900+

Published Research Related to This Trial

Syntocinon(R), a synthetic form of oxytocin, was found to be as effective as natural oxytocin in a study involving 3,342 obstetrical patients.
The use of Syntocinon(R) showed no significant side effects, such as vasospasm or anaphylactic reactions, suggesting it is safe for clinical use in obstetrics when properly indicated and monitored.
Synthetic oxytocin.HIBBARD, LT., ANDREWS, AV.[2018]
Intranasal oxytocin has been studied in 261 children across various trials, primarily focusing on autism spectrum disorder (ASD) and Prader-Willi syndrome (PWS), but results for efficacy in ASD are mixed and there is currently no evidence supporting its benefit for PWS.
Adverse events related to intranasal oxytocin are mostly mild, with few moderate or severe cases reported, indicating a generally safe profile; however, monitoring and reporting of these events are inconsistent, highlighting the need for improved adherence and safety protocols in future studies.
A Review of the Safety, Efficacy and Mechanisms of Delivery of Nasal Oxytocin in Children: Therapeutic Potential for Autism and Prader-Willi Syndrome, and Recommendations for Future Research.DeMayo, MM., Song, YJC., Hickie, IB., et al.[2018]
This study is the first double-blind randomized controlled trial examining the side effects of intranasal oxytocin in 100 elementary school-aged children, showing that it is likely safe with no significant side effects reported.
Most side effects were mild and resolved within 24 hours, indicating that intranasal oxytocin is well tolerated in children aged 8-12 years.
No side-effects of single intranasal oxytocin administration in middle childhood.Verhees, MWFT., Houben, J., Ceulemans, E., et al.[2019]

Citations

Oxytocin Substitution Therapy in Patients With Central ...This randomized, placebo-controlled, double-blind trial aims to investigate intranasal OXT as a novel therapeutical option in central diabetes insipidus ...
Study on Oxytocin Nasal Spray for Patients with Central ...This clinical study investigates the effects of an oxytocin nasal spray on anxiety and emotion recognition in patients with central diabetes insipidus.
A Pilot Randomized Clinical Trial of Intranasal Oxytocin to ...A pilot randomized clinical trial of intranasal oxytocin to promote weight loss in individuals with hypothalamic obesity.
Intranasal Oxytocin for Central Diabetes InsipidusThis 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.
Long-term intranasal oxytocin therapy in patients with ...Studies have revealed a 42% reduction in oxytocin-containing neurons in the paraventricular nucleus of the hypothalamus in PWS patients (15), ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security