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

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Acetylcysteine; Inositol; N-monoacetylcystine

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.