Phase 4
N=27
A Clinical Trial Via Telepsychiatry of Treatments for the Management of Emotional Dysregulation in Youth
Mood Disturbance · Mood Disorders · Natural Supplements · Alternative Treatment
Bottom Line
View on ClinicalTrials.gov: NCT03911414 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Mean Change in the Parent-Young Mania Rating Scale (P-YMRS) Score — -2.4; -1.9 Units on YMRS Scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Open-label Treatment with Omega-3 Fatty Acids + Inositol (Drug); Open-label Treatment with N-acetylcysteine (Drug)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in the Parent-Young Mania Rating Scale (P-YMRS) Score |
-2.4; -1.9 | — |
| SECONDARY Mean Change in the Parent-completed Children's Depression Inventory (CDI) |
-1.7; -3.5 | — |
| SECONDARY Mean Change in the NIMH Clinical Global Improvement Scale (CGI) |
-0.6; -0.6 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03911414). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.