The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation
Starting soon · Early Phase 1 · Has a placebo group
Conditions studied: Emotional Dysregulation
In brief
This is a double-blind randomized controlled study. The study will last up to 16 weeks from the initial phone screen (it could take up to eight weeks to schedule and complete the initial screening process and schedule the 2 MRI visits). Once subjects have completed the screening process, they will begin the 8-week trial phase. Subjects will be assessed weekly throughout the study for efficacy and tolerability. The investigators plan to recruit 80 participants with emotional dysregulation (ED) in the treatment arm. In addition, the investigators will aim to recruit 40age-, sex-, and parental-education matched participants without emotional dysregulation, and major psychopathology as Typically Developing (TD) control participants in the control arm. Upon scheduling the baseline visit, only the emotional dysregulation (ED) participants will be randomized 1:1 to be exposed to NAC or placebo treatment for 8 weeks. Participants will complete baseline and post-treatment (endpoint) brain MRI acquisition. TD participants will complete the same screening and characterization process as the ED group and then will be invited to complete MRI eligibility screening and to be scanned twice, separated by an eight-week interval, but the TD will not complete the NAC treatment or receive a placebo. See Table 1 (Study Schema) for a complete list of characterization measures to be completed by each group.
Key facts
- Study ID
- NCT07323446
- Run by
- Massachusetts General Hospital
- People needed
- 120
- Starts
- 2027-01-01
- Expected to finish
- 2030-01-01
- Last updated by the study team
- 2026-04-17
Who can join
Age: 6 and older, up to 12. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Emotional Dysregulation Group
- Male or female subjects, 6-12 years of age.
- Current symptoms of emotional dysregulation as indicated by combined T-scores on the Child Behavior Checklist > 180 on the Anxiety/Depression + Aggression + Attention subscales.
- Score 15 or above on the clinician YMRS
- 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.
- Subjects and their legal representative must be considered reliable.
- 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.
- Subject must have access to a computer with a camera, speaker, microphone, and internet connection.
- Subject must be willing to refrain from treatment changes during the study protocol.
- Typically Developing Control Group
- Age-, sex-matched with ED participants.
- No significant traits of ED as screened by parent and clinician YMRS both under scores of 6
- No previous psychiatric history as confirmed by clinician interview
- No significant psychopathology as screened on the CBCL (Subdomain T-scores <60).
- 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)
You may not qualify if…
- Investigator and his/her immediate family (defined as the investigator's spouse, parent, child, grandparent, or grandchild).
- Serious or unstable illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
- History of bleeding diathesis, including those with von Willebrand disease.
- Uncorrected hypothyroidism or hyperthyroidism.
- 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.
- Severe allergies or multiple adverse drug reactions.
- Current or past history of seizures.
- DSM-IV substance use, abuse, or dependence
- Any concomitant medication with primary central nervous system activity other than specified in the Concomitant Medication portion of the protocol.
- Current diagnosis of schizophrenia or psychosis.
- Females who have started menstruating.
- Pregnant or nursing.
- Judged to clinically be at serious suicidal risk or C-SSRS score ≥ 4.
- History of intellectual disability as reported by parent
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Massachusetts Institute of Technology — Cambridge, Massachusetts, United States
Full record on ClinicalTrials.gov
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