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NCT07323446 · ClinicalTrials.gov registry record · Early Phase 1
The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation
A Early Phase 1 study, sponsored by Massachusetts General Hospital.
- Not yet
- Registry status
- Early Phase 1
- Development phase
- 120
- Enrollment target
NCT07323446: Clinical Trial Early Phase 1 study, sponsored by Massachusetts General Hospital.
NCT07323446 is a Early Phase 1 study that has not yet begun recruiting, run by Massachusetts General Hospital. The registered enrollment target is 120 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (126% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07323446, a Early Phase 1 study, has not yet begun recruiting, sponsored by Massachusetts General Hospital.
- NOT YET RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 120 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG N-Acetyl Cysteine (NAC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2027-01-01 |
| Est. Completion | 2030-01-01 |
| Phase | Early Phase 1 |
What is known before NCT07323446 opens enrollment
NCT07323446 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (126% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07323446 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07323446 about?
NCT07323446 is a clinical study titled "The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation". 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 b...
What is the current status of trial NCT07323446?
This trial is currently not yet recruiting. It is a Early Phase 1 study. The enrollment target is 120 participants. The study started on 2027-01-01. Estimated completion is 2030-01-01.
What interventions are being tested in trial NCT07323446?
The interventions under investigation include: Placebo (DRUG), N-Acetyl Cysteine (NAC) (DRUG).
Who is sponsoring clinical trial NCT07323446?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07323446's enrollment target sits among peer trials
120 149th of 2000 higher than 1,843 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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