Clinical Trial

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

Study acronym: MIND
Not Yet Recruiting Early Phase 1
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-12-22.
Trial Details
NCT Number NCT07323446
Lead Sponsor Massachusetts General Hospital
Collaborators: Massachusetts Institute of Technology
Conditions Emotional Dysregulation
Enrollment 120 participants
Start Date 2027-01-01
Primary Completion 2030-01-01 (estimated)
Study Completion 2030-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-17