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NOT YET RECRUITING
NCT07323446
EARLY_PHASE1

The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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