Could a common supplement calm Kids' mood swings? new trial investigates
NCT ID NCT07323446
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether N-Acetylcysteine (NAC), a supplement, can help children ages 6-12 who struggle with emotional dysregulation (severe mood swings, irritability). Half of the 80 children with emotional dysregulation will receive NAC daily for 8 weeks, while the other half get a placebo. Brain scans before and after treatment will look for changes. The goal is to see if NAC can reduce symptoms like mania and depression, offering a potential new option for families.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- N-Acetylcysteine (NAC)
- What this could lead to
- If it works, this could point toward a safe, over-the-counter supplement option to help children with emotional dysregulation, reducing mood swings and irritability.
- What could go wrong
- This is a very early (Phase 1) trial with only 120 participants, so results may not apply broadly. NAC may not improve symptoms, and side effects are not yet well understood in children.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 12 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: \- Emotional Dysregulation Group 1. Male or female subjects, 6-12 years of age. 2. Current symptoms of emotional dysregulation as indicated by combined T-scores on the Child Behavior Checklist \> 180 on the Anxiety/Depression + Aggression + Attention subscales. 3. Score 15 or above on the clinician YMRS 4. Subjects and their legal representative must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol. 5. Subjects and their legal representative must be considered reliable. 6. Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must provide written consent and the subject must provide written assent. 7. Subject must have access to a computer with a camera, speaker, microphone, and internet connection. 8. Subject must be willing to refrain from treatment changes during the study protocol. Typically Developing Control Group 1. Age-, sex-matched with ED participants. 2. No significant traits of ED as screened by parent and clinician YMRS both under scores of 6 3. No previous psychiatric history as confirmed by clinician interview 4. No significant psychopathology as screened on the CBCL (Subdomain T-scores \<60). 5. Participant weight is above the 5th percentile and below the 95th percentile, per CDC child BMI categories (https://www.cdc.gov/obesity/basics/childhood-defining.html) Exclusion Criteria: 1. Investigator and his/her immediate family (defined as the investigator's spouse, parent, child, grandparent, or grandchild). 2. Serious or unstable illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease. 3. History of bleeding diathesis, including those with von Willebrand disease. 4. Uncorrected hypothyroidism or hyperthyroidism. 5. History of sensitivity to N-acetylcysteine, a history of intolerance to N-acetylcysteine or a non-responder after 2 months of treatment at adequate doses as determined by the clinician. 6. Severe allergies or multiple adverse drug reactions. 7. Current or past history of seizures. 8. DSM-IV substance use, abuse, or dependence 9. Any concomitant medication with primary central nervous system activity other than specified in the Concomitant Medication portion of the protocol. 10. Current diagnosis of schizophrenia or psychosis. 11. Females who have started menstruating. 12. Pregnant or nursing. 13. Judged to clinically be at serious suicidal risk or C-SSRS score ≥ 4. 14. History of intellectual disability as reported by parent
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Contact Email: •••••@•••••
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Massachusetts Institute of Technology
Cambridge, Massachusetts, 02139, United States
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