Management of Emotional Dysregulation in Youth With Non-verbal Learning Disability (NVLD) and/or Autism Spectrum Disorders (ASD) Using Telepsychiatry of Complementary and Alternative Treatments



Status:Not yet recruiting
Conditions:Neurology, Neurology, Psychiatric, Psychiatric, Autism, Autism
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:5 - 17
Updated:12/5/2018
Start Date:December 2018
End Date:December 2020
Contact:Abigail Farrell, BS
Email:aefarrell@partners.org
Phone:617-643-6617

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An Open-Label Clinical Trial Conducted Via Telepsychiatry of Complementary and Alternative Treatments (Omega-3 Fatty Acids and Inositol vs. N-acetylcysteine) for the Management of Emotional Dysregulation in Youth With Non-verbal Learning Disability (NVLD) and/or Autism Spectrum Disorders (ASD)

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-Acetyl Cysteine (NAC) in the treatment of mood dysregulation in children and adolescents
with non-verbal learning disability (NVLD) or Autism Spectrum Disorder (ASD). Subjects will
include youth ages 5-17 years with a non-verbal learning disability (NVLD) or autism spectrum
disorder (ASD) and current symptoms of emotional dysregulation.


Inclusion Criteria:

- 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195 on the Withdrawn + Social Problems + Thought Problems subscales.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 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 for C-SSRS score ≥ 4.

- Current diagnosis of schizophrenia.

- Current diagnosis or symptoms of psychosis.

- IQ < 70.

- Pregnant or nursing.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Janet Wozniak, MD
Phone: 617-643-6617
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mi
from
Boston, MA
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