N-Acetyl Cysteine for Emotional Dysregulation
(MIND Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether N-Acetyl Cysteine (NAC), taken as a daily tablet, can help with emotional dysregulation (ED). Emotional dysregulation involves frequent and intense emotional reactions, such as anxiety or aggression, that can disrupt daily life. The trial will test NAC's effectiveness compared to a placebo (a non-active pill) over eight weeks. Children aged 6-12 with significant emotional challenges, identified by specific behavior scores, may qualify to participate. The study includes brain imaging before and after the treatment to observe any changes. As an Early Phase 1 trial, this research focuses on understanding how NAC works in children, offering participants a chance to contribute to groundbreaking insights.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop your current medications, but it mentions that you should not change your treatments during the study. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that N-Acetyl Cysteine (NAC) is likely to be safe for humans?
Research shows that N-Acetyl Cysteine (NAC) is generally safe and well-tolerated. It has been used in treating mental health conditions like schizophrenia and depression without major safety issues. One review found NAC to be safe when used alongside other treatments for moderate to severe OCD (obsessive-compulsive disorder).
While NAC is usually well-tolerated, it can interact with other medications, potentially affecting their efficacy. People with certain health conditions should exercise caution when using it. However, these concerns are generally not significant for most individuals.
Overall, NAC's safety is reassuring, but more studies are needed to confirm this in different conditions. Prospective trial participants should discuss these findings with a healthcare provider to address any concerns.12345Why do researchers think this study treatment might be promising for emotional dysregulation?
N-Acetylcysteine (NAC) is unique because it offers a fresh approach to managing emotional dysregulation by targeting oxidative stress and inflammation in the brain, which are not the primary targets of most current treatments. Standard treatments often involve psychotherapy and medications like mood stabilizers or antidepressants that focus on neurotransmitter balance. NAC stands out due to its ability to potentially modulate glutamate and antioxidant levels, offering a novel mechanism of action. Researchers are excited about NAC because it could complement existing therapies, providing an alternative for individuals who do not respond well to traditional treatments. Plus, NAC is available in an easy-to-take effervescent tablet form, which might improve adherence for some patients.
What evidence suggests that N-Acetyl Cysteine might be an effective treatment for emotional dysregulation?
Research has shown that N-Acetyl Cysteine (NAC), which participants in this trial may receive, might help with emotional issues by improving behavior and reducing irritability. A review of several studies found that NAC significantly improved scores on a checklist measuring irritability and hyperactivity. In studies on major depression, NAC also reduced the severity of symptoms, suggesting it might help with emotional challenges. These findings indicate that NAC could benefit emotional regulation issues. However, more research is needed to confirm these effects specifically for emotional difficulties.15678
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
Citations
The Potential of N-Acetyl-L-Cysteine (NAC) in the Treatment of ...
The meta-analysis found that NAC significantly improved Aberrant Behaviour Checklist (ABC) total scores, and irritability and hyperactivity subscales compared ...
The MIND Study: The MGH/MIT Investigation of NAC on ...
This will be an 8-week, double-blind randomized controlled study of NAC in the treatment of emotional dysregulation in children and adolescents.
A multi-centre, double-blind, 12-week, randomized, ...
This study aims to investigate the efficacy of adjuvant NAC in people with treatment-resistant PTSD.
The Impact of <i>N</i>-acetylcysteine on Major Depression
Clinical evidence indicates that adjunctive NAC may reduce the severity of depressive symptoms in individuals with major depressive disorder (MDD). Methods: A ...
N-acetylcysteine: A Review of Clinical Use and Efficacy
The results of the pooled data show a significant improvement with NAC in the Aberrant Behaviour Checklist (based on four studies), whilst ...
Clinical trials of N-acetylcysteine in psychiatry and neurology
Overall, NAC treatment appears to be safe and tolerable. Further well designed, larger controlled trials are needed for specific psychiatric and neurological ...
Early Study of N-Acetylcysteine to Treat Deliberate Self ...
We hypothesize that N-Acetylcysteine will reduce the severity of deliberate self harm behaviors because this supplement has been helpful in treating disorders ...
The safety and efficacy of N-acetylcysteine as ...
Our systematic review and meta-analysis suggests that NAC may serve as an effective adjunct treatment for adults with moderate to severe OCD.
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