A Clinical Trial Via Telepsychiatry of Treatments for the Management of Emotional Dysregulation in Youth
Purpose
This study consists of a 6-week, open-label, randomized clinical trial study to compare efficacy and tolerability of the natural treatments omega-3 fatty acids, inositol, and N-acetylcysteine (NAC) in the treatment of mood dysregulation in children and adolescents (ages 5-17). Subjects will be randomized to one of two arms: 1) omega-3 fatty acids plus inositol or 2) NAC.
Conditions
- Mood Disturbance
- Mood Disorders
- Natural Supplements
- Alternative Treatment
Eligibility
- Eligible Ages
- Between 5 Years and 17 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male or female subjects, 5-17 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. - Subjects and their caregivers must be English-speaking, and 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 caregivers must be willing and able to comply with all study procedures. - Each subject and his/her parent/guardian must understand the nature of the study. The subject's parent/guardian must sign an informed consent document and the subject must sign an informed assent document. - Subject must be able to swallow pills. - Subject must have access to a computer with a camera, speaker, microphone, and internet connection.
Exclusion Criteria
- 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 omega-3 fatty acids, inositol or NAC. A non-responder or history of intolerance to omega-3 fatty acid, inositol or NAC after 2 months of treatment at adequate doses as determined by the clinician. - Severe allergies or multiple adverse drug reactions. - Unstable or untreated seizure disorder. - DSM-IV substance use, abuse or dependence. - Judged clinically to be at serious suicidal risk or C-SSRS score ≥ 4. - Current diagnosis of schizophrenia. - Current diagnosis or symptoms of psychosis. - IQ < 70. - Pregnant or nursing.
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Omega-3 Fatty Acids + Inositol |
Subjects will be treated with 1020mg QAM + 1020mg QPM of omega-3 fatty acids and inositol based on weight (subjects under 25kg: 1000mg QD; Subjects weighing 25kg or more: 2000mg QD). |
|
|
Experimental N-acetylcysteine |
Subjects will be treated with N-acetylcysteine capsules (subjects ages 5-12: 1800mg QD; subjects ages 13-17: 2400mg QD) or effervescent tablets (subjects ages 5-12: 1800mg QD; subjects ages 13-17: 2700mg QD) based on age . |
|
Recruiting Locations
Massachusetts General Hospital
Boston, Massachusetts 02114-2696
Boston, Massachusetts 02114-2696
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital