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The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation
Sponsor: Massachusetts General Hospital
Summary
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.
Official title: 8-Week Double-Blind, Randomized Controlled Study of N-Acetylcysteine and Neuroimaging in Children Ages 6-12 With Emotional Dysregulation
Key Details
Gender
All
Age Range
6 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-01-01
Completion Date
2030-01-01
Last Updated
2026-01-07
Healthy Volunteers
Yes
Conditions
Interventions
N-Acetyl Cysteine (NAC)
Participants in the NAC arm will receive NAC in effervescent tablet form daily for 8 weeks . Participants will undergo neuroimaging before and after the 8-week treatment phase.
Placebo
Participants in the placebo arm will receive placebo (no active ingredients) in effervescent tablet form daily for 8 weeks. Participants will undergo neuroimaging before and after the 8-week treatment phase.
Locations (2)
Massachusetts General Hospital
Boston, Massachusetts, United States
Massachusetts Institute of Technology
Cambridge, Massachusetts, United States