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Hormone Therapy
Intranasal Oxytocin for Anxiety Disorders
Phase 2
Waitlist Available
Led By Alison M Stuebe, MD, MSc
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up minutes -40 to -35, -35 to -30, -30 to -25, -25 to -20, -20 to -15, -15 to -10, -10 to -5, -5 to 0, 0 to 5, 5 to 8, 8 to 13, 13 to 18, 18 to 23, 23 to 28, 28 to 33, 33 to 38, 38 to 43, 43 to 48
Awards & highlights
Study Summary
This trial will study the effects of oxytocin on mothers' stress levels.
Eligible Conditions
- Anxiety Disorders
- Stress
- Postpartum Depression
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ minutes -40 to -35, -35 to -30, -30 to -25, -25 to -20, -20 to -15, -15 to -10, -10 to -5, -5 to 0, 0 to 5, 5 to 8, 8 to 13, 13 to 18, 18 to 23, 23 to 28, 28 to 33, 33 to 38, 38 to 43, 43 to 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~minutes -40 to -35, -35 to -30, -30 to -25, -25 to -20, -20 to -15, -15 to -10, -10 to -5, -5 to 0, 0 to 5, 5 to 8, 8 to 13, 13 to 18, 18 to 23, 23 to 28, 28 to 33, 33 to 38, 38 to 43, 43 to 48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in Cortisol (CRT) during Trier Social Stress Test (TSST)
Secondary outcome measures
Changes in Adrenocorticotropic hormone (ACTH ) during TSST
Changes in high frequency heart rate variability, an index of parasympathetic activity, during the TSST
Changes in pre-ejection period, an index of sympathetic activity, during the TSST
+1 moreOther outcome measures
Assessment of effect modification by OXTR genotype changes in high frequency heart rate variability, an index of parasympathetic activity, during the TSST
Assessment of effect modification by OXTR genotype on changes in Adrenocorticotropic hormone (ACTH ) during TSST
Assessment of effect modification by OXTR genotype on changes in Cortisol (CRT) during Trier Social Stress Test (TSST)
+5 moreSide effects data
From 2018 Phase 2 & 3 trial • 43 Patients • NCT0225535720%
feeling energized
7%
calm
7%
less irritable
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Intranasal Syntocinon
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intranasal OxytocinExperimental Treatment1 Intervention
Participants block randomized to Oxytocin intranasal spray by risk status at enrollment in the Mood, Mother and Infant (MMI) study and as verified by structured clinical diagnostic interview (no history of depression or anxiety, past depression or anxiety, current depression or anxiety).
Group II: PlaceboPlacebo Group1 Intervention
Participants block randomized to placebo Intranasal spray with all equivalent ingredients except oxytocin. Blocks will be stratified by risk status at enrollment in the Mood, Mother and Infant (MMI) study and as verified by structured clinical diagnostic interview (no history of depression or anxiety, past depression or anxiety, current depression or anxiety).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxytocin
FDA approved
Find a Location
Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,963 Previous Clinical Trials
2,674,636 Total Patients Enrolled
4 Trials studying Anxiety Disorders
385 Patients Enrolled for Anxiety Disorders
University of North Carolina, Chapel HillLead Sponsor
1,504 Previous Clinical Trials
4,187,557 Total Patients Enrolled
5 Trials studying Anxiety Disorders
2,930 Patients Enrolled for Anxiety Disorders
Alison M Stuebe, MD, MScPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You were born with a significant birth defect.You plan to breastfeed your baby, which is important for studying the effects of oxytocin.This study will only include women who were previously part of a research project called the Mood, Mother and Infant (MMI) study. In that study, 222 mothers and their infants were recruited from community clinics during pregnancy and followed up to 12 months after birth. The mothers were invited to continue participating in the study through online surveys every 6 months, and over 80% of them have continued to do so.You are currently taking tricyclic antidepressants, which can affect your cortisol levels and heart rate variability.
Research Study Groups:
This trial has the following groups:- Group 1: Intranasal Oxytocin
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
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.
Is it possible to experience negative side effects from Intranasal Oxytocin?
"Intranasal Oxytocin is a Phase 2 medication, which suggests that while there is some data affirming its safety, none exists yet to support efficacy."
Answered by AI
Could you tell me if this clinical trial is still enrolling patients?
"No, this study is no longer recruiting patients. It was open from February 7th, 2019 to September 29th, 2021. If you are interested in other studies, 618 trials for stress-related conditions and 57 for Intranasal Oxytocin are currently looking for participants."
Answered by AI
What conditions or symptoms does Intranasal Oxytocin commonly target?
"Many times, Intranasal Oxytocin is the best course of action to stop hemorrhaging. Additionally, this medication can be used to help with other issues like uterine contractions during labour or reinforcing labor."
Answered by AI
How many people have been recruited for this experiment?
"This study is not recruiting patients at the present time. It was first posted on February 7th, 2019 and was updated most recently on September 29th, 2021. There are other studies you may be eligible for; 618 trials related to stress and psychological factors, and 57 research projects involving Intranasal Oxytocin are actively searching for participants."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
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