N-Acetyl Cysteine for Emotional Dysregulation
(MIND Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Janet Wozniak, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
The MIND Study is for children aged 6-12 with emotional dysregulation, as shown by specific scores on behavior checklists and assessments. They must understand the study requirements and agree to all tests. A control group of typically developing children without major psychopathology will also participate.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Baseline assessments including questionnaires and MRI eligibility screening
Treatment
Participants receive NAC or placebo treatment for emotional dysregulation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- N-Acetyl Cysteine (NAC)
Trial Overview
This trial tests if N-Acetyl Cysteine (NAC) can help manage emotional dysregulation over an 8-week period compared to a placebo. It's double-blind, meaning neither participants nor researchers know who gets NAC or placebo. Brain MRIs are done before and after treatment.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Placebo Group
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. Interventions: Drug: N-Acetylcysteine (NAC)
Typically-developing controls will undergo neuroimaging twice (8 weeks apart) and will receive no intervention during the 8-week window.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Massachusetts Institute of Technology
Collaborator
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