The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation
ConditionEmotional Dysregulation
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age6-12
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
N-Acetyl Cysteine (NAC)
DrugParticipants 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
DrugParticipants 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.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: N-Acetylcysteine (also known as NAC)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to Endpoint (Week 8)2
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.
Time frame
Baseline to Endpoint (Week 8)3
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.
Time frame
Baseline to Endpoint (Week 8)Secondary outcomes
1
Mean Change in Child Behavior Checklist (CBCL) scores
The CBCL (Achenbach 2000) is a standardized assessment of child behavior problems and social competence. Due to its extensive use and available norms, it provides us with an effective method of comparing our sample with others in the literature. The CBCL records, in standardized format, the behavioral problems and competencies of children aged 4 to 18, as reported by their parents or parent- surrogates. The CBCL is scored on the recently revised social competence and behavior problem scales of the Child Behavior Profile. A T-score above 70 is considered to be a clinically meaningful indicator of childhood psychopathology. Administered during pre-screening procedures as part of inclusionary criteria as well as at post-treatment completion.
Time frame
Baseline to Endpoint (Week 8)2
Mean Change in Social Responsiveness Scale (SRS) Scores
The SRS is a 65-item rating scale completed by the parent or guardian. This scale measures the severity of autism spectrum symptoms as they occur in natural social settings. Collected at screening and endpoint visits as assessment of symptoms and capacities associated with social interaction.
Time frame
Baseline to Endpoint (Week 8)3
Mean Change in the Parent-Young Mania Rating Scale (P-YMRS) Score
The P-YMRS (Young, 1978) consists of 11 items rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). Items 5, 6, 8, and 9 are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). These items assess irritability, speech, content, and disruptive/aggressive behavior) and are given extra weight in the overall score. The YMRS score ranges from 0-60. 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. Collected at the screening visit, baseline visit, at each of the weekly visits, and at endpoint to assess the impact of treatment on manic symptoms
Time frame
Baseline to Endpoint (Week 8)4
Mean Change in the Children's Depression Rating Scale-Parent (CDRS-P) Score
Scale for adults, but includes questions relevant to youth, such as questions about school, family and peer functioning. This is a parent-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 weekly
Time frame
Baseline to Endpoint (Week 8)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Massachusetts Institute of Technology
Collaborator
Source ClinicalTrials.gov
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