Intranasal Oxytocin for Central Diabetes Insipidus
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intranasal oxytocin or placebo during three main study visits, followed by assessments of emotional behavior
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Oxytocin nasal spray
Oxytocin nasal spray is already approved in United States, European Union for the following indications:
- Induction of labor
- Stimulation of uterine contractions
- Induction of labor
- Stimulation of uterine contractions
Find a Clinic Near You
Who Is Running the Clinical Trial?
Elizabeth Austen Lawson
Lead Sponsor
Tonix Pharmaceuticals, Inc.
Industry Sponsor