A Clinical Trial Via Telepsychiatry of Treatments for the Management of Emotional Dysregulation in Youth

Completed · Phase 4

Conditions studied: Mood Disturbance, Mood Disorders, Natural Supplements, Alternative Treatment

In brief

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.

Key facts

Study ID: NCT03911414
Run by: Massachusetts General Hospital
People needed: 27
Starts: 2019-06-18
Expected to finish: 2024-12-04
Last updated by the study team: 2026-03-18

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

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 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.

Where it is running

Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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