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

Conditions

• Emotional Dysregulation

Eligibility Criteria

Sex

ALL

Age

6 Years - 12 Years

Healthy Volunteers

Accepted

Interventions

• N-Acetyl Cysteine (NAC) — DRUG
  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.
• Placebo — DRUG
  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.

Study Details

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.

Key Dates

Start date

Jan 1, 2027

Status verified

Apr 2026

Primary completion

Jan 1, 2030

Completion

Jan 1, 2030

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: N-Acetylcysteine (also known as 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. Interventions: Drug: N-Acetylcysteine (NAC)
• Placebo Comparator: Placebo
  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.
• No Intervention: Control Group
  Typically-developing controls will undergo neuroimaging twice (8 weeks apart) and will receive no intervention during the 8-week window.

Primary Outcome Measure

Mean Change in the Clinician-Young Mania Rating Scale (C-YMRS) Score [ Time Frame: Baseline to Endpoint (Week 8) ]

Central Contacts

• Maria Iorini, BD
  617-643-6617
  [email protected]

Locations (2)

Find similar trials in Boston, MA

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