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Oxytocin for Irritability
Study Summary
This trial will test whether oxytocin can help reduce irritability in adolescents. 80 subjects will be enrolled over 3 years.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am between 14 and 18 years old.I do not have severe mental health or substance use issues, nor do I have major illnesses like severe liver disease.I have a history of serious brain or nervous system conditions.You have any metal objects in your body (like a pacemaker or braces) or suffer from claustrophobia, which could prevent you from undergoing an MRI scan.I have been diagnosed with ADHD, ODD, CD, or DMDD.My current medication has been stable for the required time.You have a high level of irritability as measured by the Affective Reactivity Index (ARI) score of 4 or more.You have had an allergic reaction to OXT or its intranasal product before.
- Group 1: Intranasal Spray Placebo
- Group 2: Oxytocin Intranasal Spray 8 International Unit (IU)
- Group 3: Oxytocin Intranasal Spray 24 International Unit (IU)
- Group 4: Oxytocin Intranasal Spray 48 International Unit (IU)
- Group 5: Oxytocin Intranasal Spray 80 International Unit (IU)
- 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
Has recruitment for this experiment commenced?
"As confirmed by information on clinicaltrials.gov, the medical trial began recruiting patients in February of 2022 and was recently amended 22 July."
What are the main aims of this clinical investigation?
"This experiment will evaluate the regional brain activity changes to emotional stimuli following intranasal OXT administration. The primary outcome is BOLD response within rmPFC region of interest at approximately 50 minutes post-administration, whereas secondary objectives include Neural changes observable on fMRI in PAG and amygdala regions as well as salivary level of OXT concentration and AUC (Area under curve)."
How many participants are accepted for this experiment?
"Affirmative. Clinicaltrials.gov reveals that this research is currently canvassing for patients, with the first posting taking place on February 18th 2022 and most recent refresh happening July 22nd 2022. The project requires 80 participants across a single site."
Are geriatric patients excluded from this experiment?
"This trial is designed for adolescents aged 14 to 18, within which there are 16 other clinical trials. Additionally, 31 studies have been developed specifically with the elderly population of over 65 in mind."
May I join this medical experiment?
"To qualify for inclusion in this trial, candidates must be displaying signs of irritability and between the ages of 14-18. The desired participant count is 80 individuals."
What conditions has Oxytocin Intranasal Spray 48IU been proven to alleviate?
"Oxytocin Intranasal Spray 48IU is commonly prescribed to address postpartum bleeding, as well as labor induction and uterine contractions."
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