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Could a common supplement calm Kids' mood swings? new trial investigates

NCT ID NCT07323446

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

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

6 to 12 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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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As listed by the trial registrant

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How to take part

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    2 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

    Contact Email: •••••@•••••

  • Massachusetts Institute of Technology

    Cambridge, Massachusetts, 02139, United States

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