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

NCT07323446 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 2025P002315
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Emotional Dysregulation

Keywords

NAC; Emotional Dysregulation; Pediatric

Outcome Measures

Primary Outcomes (3)

• Mean Change in the Clinician-Young Mania Rating Scale (C-YMRS) Score

  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.

  Baseline to Endpoint (Week 8)

• Mean Change in the Clinical Global Impression (CGI) scale for mania, depression, and bipolar disorder.

  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.

  Baseline to Endpoint (Week 8)

• Change from baseline to endpoint in the clinician measure Children's Depression Rating Scale (CDRS)

  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.

  Baseline to Endpoint (Week 8)

Secondary Outcomes (5)

• Mean Change in Child Behavior Checklist (CBCL) scores

  Baseline to Endpoint (Week 8)

• Mean Change in Social Responsiveness Scale (SRS) Scores

  Baseline to Endpoint (Week 8)

• Mean Change in the Parent-Young Mania Rating Scale (P-YMRS) Score

  Baseline to Endpoint (Week 8)

• Mean Change in the Children's Depression Rating Scale-Parent (CDRS-P) Score

  Baseline to Endpoint (Week 8)

• Mean Change in the Modified Overt Aggression Scale (MOAS)- Parent

  Baseline to Endpoint (Week 8)

Study Arms (3)

N-Acetylcysteine (also known as NAC)

EXPERIMENTAL

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)

Drug: N-Acetyl Cysteine (NAC)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Control Group

NO INTERVENTION

Typically-developing controls will undergo neuroimaging twice (8 weeks apart) and will receive no intervention during the 8-week window.

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.

N-Acetylcysteine (also known as NAC)

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.

Placebo

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- Emotional Dysregulation Group
• Male or female subjects, 6-12 years of age.
• Current symptoms of emotional dysregulation as indicated by combined T-scores on the Child Behavior Checklist \> 180 on the Anxiety/Depression + Aggression + Attention subscales.
• Score 15 or above on the clinician YMRS
• 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.
• Subjects and their legal representative must be considered reliable.
• Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must provide written consent and the subject must provide written assent.
• Subject must have access to a computer with a camera, speaker, microphone, and internet connection.
• Subject must be willing to refrain from treatment changes during the study protocol.
• Typically Developing Control Group
• Age-, sex-matched with ED participants.
• No significant traits of ED as screened by parent and clinician YMRS both under scores of 6
• No previous psychiatric history as confirmed by clinician interview
• No significant psychopathology as screened on the CBCL (Subdomain T-scores \<60).
• Participant weight is above the 5th percentile and below the 95th percentile, per CDC child BMI categories (https://www.cdc.gov/obesity/basics/childhood-defining.html)

You may not qualify if:

• Investigator and his/her immediate family (defined as the investigator's spouse, parent, child, grandparent, or grandchild).
• Serious or unstable illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
• History of bleeding diathesis, including those with von Willebrand disease.
• Uncorrected hypothyroidism or hyperthyroidism.
• History of sensitivity to N-acetylcysteine, a history of intolerance to N-acetylcysteine or a non-responder after 2 months of treatment at adequate doses as determined by the clinician.
• Severe allergies or multiple adverse drug reactions.
• Current or past history of seizures.
• DSM-IV substance use, abuse, or dependence
• Any concomitant medication with primary central nervous system activity other than specified in the Concomitant Medication portion of the protocol.
• Current diagnosis of schizophrenia or psychosis.
• Females who have started menstruating.
• Pregnant or nursing.
• Judged to clinically be at serious suicidal risk or C-SSRS score ≥ 4.
• History of intellectual disability as reported by parent

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Massachusetts Institute of Technology: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Massachusetts Institute of Technology

Cambridge, Massachusetts, 02139, United States

Location

MeSH Terms

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Janet Wozniak, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Iorini, BD

CONTACT

617-643-6617; themindstudy@mgb.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 7, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)