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Hormone Therapy
Oxytocin Nasal Spray for Social Anxiety Disorder
Phase 2
Recruiting
Led By Angela Fang, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after the intervention
Awards & highlights
Study Summary
This trial is studying if oxytocin, a hormone and chemical messenger in the brain, can help adults with social anxiety disorder learn safety skills when compared to healthy adults. 120 people will take part at the University of Washington.
Who is the study for?
This trial is for adults aged 18-45 with social anxiety disorder (SAD) and healthy volunteers without psychiatric, neurological, or medical disorders. Women must have regular menstrual cycles and not be on oral contraception. Participants cannot be pregnant, breastfeeding, using drugs, or have a history of serious mental health issues like mania or psychosis.Check my eligibility
What is being tested?
The study tests if oxytocin nasal spray can improve social safety learning in people with SAD compared to healthy individuals. Oxytocin affects fear response and social behavior. The effects of the oxytocin spray will be compared to a placebo in about 120 participants at the University of Washington.See study design
What are the potential side effects?
Oxytocin may cause side effects such as irritation at the site of administration, headaches, possible emotional changes due to its role in mood regulation, and allergic reactions although these are generally rare.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately after the intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after the intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
neural responses (e.g., regional brain activation in the ventromedial prefrontal cortex (vmPFC) to vicariously extinguished cue versus vicariously reinforced cue during reinstatement
Secondary outcome measures
skin conductance responses (SCR) to vicariously extinguished cue versus vicariously reinforced cue during reinstatement
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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ClinicalExperimental Treatment1 Intervention
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive either an oxytocin or placebo administration (blind randomization).
Group II: ControlsPlacebo Group1 Intervention
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive either an oxytocin or placebo administration (blind randomization).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxytocin nasal spray
2016
Completed Phase 4
~1490
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,640 Total Patients Enrolled
Angela Fang, PhDPrincipal InvestigatorUniversity of Washington
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of nasal problems.I have never been diagnosed with mania or psychotic disorders.I have no serious illnesses or untreated hormone-related diseases.I am between 18 and 45 years old.I have regular menstrual cycles and do not use oral contraceptives.My primary diagnosis is social anxiety disorder.I am a woman with regular periods and do not use birth control pills.I have never had psychiatric, neurological, or medical disorders.I am currently taking medication for mental health or steroids.I have had a head injury, neurological disorder, or neurosurgery.I am between 18 and 45 years old.This criterion is for individuals who are not currently experiencing any health problems.I have no history of psychiatric, neurological, or medical disorders.I have been diagnosed with social anxiety disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Clinical
- Group 2: Controls
Awards:
This trial has 0 awards, including: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.
Social Anxiety Disorder Patient Testimony for trial: Trial Name: NCT05968651 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is qualified to participate in this experiment?
"For admittance to this medical trial, volunteers must suffer from social anxiety disorder and be between 18-45 years old. Up to 120 individuals will be accepted into the study."
Answered by AI
Are elderly individuals welcome to participate in this research program?
"Eligible candidates for this medical trial should be aged 18 to 45. For those younger than 18 or over 65, there are 13 and 28 trials respectively."
Answered by AI
How many individuals are participating in this experiment?
"Affirmative, per the information on clinicaltrials.gov this trial is actively seeking participants. This particular research endeavour was initially posted in late June 2023 and most recently updated at the end of July 2023; with a goal to enroll 120 volunteers from one site."
Answered by AI
Has the Clinical product been authorized by the FDA?
"Our evaluation placed the safety of this drug at a 2 due to its Phase 2 status. Although there are data points that attest to safety, efficacy is yet unproven."
Answered by AI
Is it currently possible to join this investigation?
"As per clinicaltrials.gov, this research effort is currently looking for enrollees. This trial was made available on June 26th of 2023 and the information was last modified on July 26th of 2023."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What site did they apply to?
University of Washington
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
My social anxiety has been unsuccessfully treated. I have been studying the effects of Oxytocin on the brain, and its potential improve fear based responses to social interactions. I am hoping this clinical trial will help address my medical condition.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
Recent research and studies
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