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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 40 minutes following intervention at each main visit
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have been diagnosed with central diabetes insipidus.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 40 minutes following intervention at each main visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~40 minutes following intervention at each main visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dot-probe task - anxious behavior between low dose oxytocin and placebo
Secondary outcome measures
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 • NCT0311961058%
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
1 Previous Clinical Trials
46 Total Patients Enrolled
Elizabeth A Lawson, MD, MMScPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
56 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of severe mental illness that includes losing touch with reality.I have been diagnosed with central diabetes insipidus.Your ALT or AST levels are more than 2.5 times the upper limit of normal.Your hematocrit level is significantly below the normal range.You have been misusing drugs or alcohol in the last 6 months.Your creatinine level is higher than 1.5mg/dL.Low sodium levelsI am currently experiencing thoughts of harming myself.I haven't changed my medications in the last 4 weeks and won't during the study.I have a history of heart disease but not high blood pressure alone.Your thyroid hormone levels are within the normal range.My hormone replacement dose has been stable for the last six weeks.
Research Study Groups:
This trial has the following groups:- Group 1: 4 IU oxytocin - 24 IU oxytocin - placebo
- Group 2: 4 IU oxytocin - placebo - 24 IU oxytocin
- Group 3: 24 IU oxytocin - 4 IU oxytocin - placebo
- Group 4: 24 IU oxytocin - placebo - 4 IU oxytocin
- Group 5: Placebo - 4 IU oxytocin - 24 IU oxytocin
- Group 6: Placebo - 24 IU oxytocin - 4 IU oxytocin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been initiated into this trial thus far?
"This research trial is no longer taking on participants. It was first posted in June of 2023 and last edited on November 30th 2022. Alternately, 1171 trials are actively recruiting for central diabetes insipidus and 53 studies with regards to Oxytocin nasal spray have open enrolment opportunities."
Answered by AI
Am I eligible to partake in this experiment?
"Prospective participants must meet the requirements of this experiment: they ought to have central diabetes insipidus and be between 18-60 years old. The clinical trial is looking for a total of 30 qualified volunteers."
Answered by AI
Is this research endeavor presently accessible to participants?
"The current recruitment period for this clinical trial has concluded. Initially posted on June 1st 2023, the study was last updated on November 30th 2022 and is no longer seeking participants. In contrast, 1171 different trials are actively searching for patients with central diabetes insipidus while 53 trials require volunteers to test Oxytocin nasal spray."
Answered by AI
What have medical practitioners historically used Oxytocin nasal spray to treat?
"The oxytocin nasal spray is widely prescribed to stop hemorrhage, but can also aid with labor processes, uterine contractions, and augmentation of childbirth."
Answered by AI
Is the eligibility for this trial open to those aged 30 and older?
"This research requires that participants are between 18 to 60 years old. In contrast, there is a total of 194 trials for those under the age of 18 and 906 studies available for persons beyond 65 years."
Answered by AI
What potential risks or complications may arise from using Oxytocin nasal spray?
"Due to the limited safety and efficacy data, our team at Power rated oxytocin nasal spray a 1 on a scale of 1-3."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Massachusetts General Hospital, Neuroendocrine Unit
What portion of applicants met pre-screening criteria?
Met criteria
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