8-Week Double-Blind, Randomized Controlled Study of N-Acetylcysteine and Neuroimaging in Children Ages 6-12 With Emotional Dysregulation
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.
Description
The investigators will enroll 120 subjects. Participants will be 80 children with emotion dysregulation, 6-12 years of age. In addition, the investigators will include 40 children without emotion dysregulation as healthy controls to provide a normative comparison group for neuroimaging analyses. All subjects that enter the study will undergo standard screening and diagnostic procedures. Individuals who express interest in the study, either by responding to advertising or by giving a referring clinician explicit permission to be contacted for research, will be screened for eligibility by the s…
Eligibility
- Age range
- 6–12 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: \- Emotional Dysregulation Group 1. Male or female subjects, 6-12 years of age. 2. Current symptoms of emotional dysregulation as indicated by combined T-scores on the Child Behavior Checklist \> 180 on the Anxiety/Depression + Aggression + Attention subscales. 3. Score 15 or above on the clinician YMRS 4. 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. 5. Subjects and their legal represe…
Interventions
- DrugN-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.
- DrugPlacebo
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 HospitalBoston, Massachusetts
- Massachusetts Institute of TechnologyCambridge, Massachusetts