The MIND Study: Investigating NAC for Emotional Dysregulation
The MIND Study is looking at how N-Acetyl Cysteine (NAC), a drug given as an effervescent tablet, might help children aged 6 to 12 who experience emotional dysregulation. Some participants will receive NAC daily for 8 weeks, while others will receive a placebo (a tablet with no active ingredients). Researchers will use brain imaging before and after this 8-week period to see if NAC has an effect. The study will measure changes in emotional dysregulation symptoms using scales like the Clinician-Young Mania Rating Scale (C-YMRS), the Clinical Global Impression (CGI) scale, and the Children's Depression Rating Scale (CDRS). The goal is to see if NAC can improve these symptoms. The study is currently recruiting 120 participants, including 80 children with emotional dysregulation and 40 children without it to serve as a comparison group.
- Study design
- This is a double-blind, randomized controlled study involving 120 participants. This means neither you nor the study team will know if you are receiving NAC or the placebo.
- What's involved
- The study will last up to 16 weeks, including an initial screening process that could take up to eight weeks. After screening, you would participate in an 8-week treatment phase with weekly assessments and two MRI visits.
- Compensation
- Not stated in the trial record.
- Follow-up
- Changes in symptoms will be measured from the beginning of the study to the end of the 8-week treatment phase.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation
At a glance
Conditions
NCT07323446
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Massachusetts General Hospital
Boston, Massachusettsstudy coordinator listed
Massachusetts Institute of Technology
Cambridge, Massachusettsstudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Janet Wozniak, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Mean Change in the Clinician-Young Mania Rating Scale (C-YMRS) ScoreBaseline to Endpoint (Week 8)
The YMRS consists of 11 items rated on a scale from 0 (symptoms not present) to 4 (symptoms extremely severe). It is used to assess manic symptoms. Scores from each item are summed to obtain the total YMRS score. The YMRS score ranges from 0-60. A higher score means a higher manic state. Questions are asked about the last week. This scale is generally accepted as the main outcome measure in studies of pediatric bipolar disorder and is linked directly to the core symptoms of mania.
- Mean Change in the Clinical Global Impression (CGI) scale for mania, depression, and bipolar disorder.Baseline to Endpoint (Week 8)
The CGI is a measure of illness severity adapted for specific disorders. It allows rating of mania, depression, and overall bipolar disorder illness, as well as other conditions frequently comorbid with bipolar disorder. The severity score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The improvement score ranges from 1 (very much improved) to 7 (very much worse). Collected at the baseline visit, weeks 2, 4 and 6, and at endpoint as an accepted measure of clinician rated improvement to assess the impact of treatment on bipolar disorder and other comorbid conditions.
- Change from baseline to endpoint in the clinician measure Children's Depression Rating Scale (CDRS)Baseline to Endpoint (Week 8)
The CDRS (Poznanski, Freeman et al. 1985) is modeled after the Hamilton Depression Rating Scale for adults, but includes questions relevant to youth, such as questions about school, family and peer functioning. This is a clinician-rated instrument with 17 items scored on a 1 to 5 or 1 to 7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. Scores of 20-30 suggest borderline depression. Scores of 40-60 indicate moderate depression. This scale is generally accepted as the main outcome in studies assessing childhood depression and is linked directly to the core symptoms of depression. Collected at baseline visit, weeks 2, 4 and 6, and at endpoint.