Status:
COMPLETED
Natural Treatments for the Management of Emotional Dysregulation in Youth With Non-verbal Learning Disability (NVLD) and/or Autism Spectrum Disorders (ASD)
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Demarest Lloyd Jr. Foundation
Conditions:
Non-verbal Learning Disorder
Autism Spectrum Disorder
Eligibility:
All Genders
5-17 years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- A previous established diagnosis of non-verbal learning disability (NVLD) or DSM-V Autism Spectrum Disorder and/ or combined T-scores on the Child Behavior Checklist \> 195 on the Withdrawn + Social Problems + Thought Problems subscales.
- 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 authorized legal representative must understand the nature of the study. The subject's authorized legal representative 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
- 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 for C-SSRS score ≥ 4.
- Current diagnosis of schizophrenia.
- Current diagnosis or symptoms of psychosis.
- IQ \< 70.
- Pregnant or nursing.
- Weighs less than 12.5kg.
Key Trial Info
Start Date :
May 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2024
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03757585
Start Date
May 20 2019
End Date
May 6 2024
Last Update
June 5 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114