A Clinical Trial Via Telepsychiatry of Treatments for the Management of Emotional Dysregulation i… (NCT03911414) | Clinical Trial Compass
CompletedPhase 4
A Clinical Trial Via Telepsychiatry of Treatments for the Management of Emotional Dysregulation in Youth
United States27 participantsStarted 2019-06-18
Plain-language 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.
Who can participate
Age range5 Years – 17 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-re…
What they're measuring
1
Mean Change in the Parent-Young Mania Rating Scale (P-YMRS) Score