Phase
Condition
Autism Spectrum Disorder (Asd)
Williams Syndrome
Autism
Treatment
Open-label Treatment with N-acetylcysteine
Open-label Treatment with Omega-3 Fatty Acids + Inositol
Clinical Study ID
Ages 5-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
A previous established diagnosis of non-verbal learning disability (NVLD) or DSM-VAutism 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 195 on the Withdrawn + Social Problems + Thought Problems subscales.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 theChild Behavior Checklist > 180 on the Anxiety/Depression + Aggression + Attentionsubscales.
Subjects and their caregivers must be English-speaking and have a level ofunderstanding sufficient to communicate intelligently with the investigator andstudy coordinator, and to cooperate with all tests and examinations required by theprotocol.
Subjects and their caregivers must be willing and able to comply with all studyprocedures.
Each subject and his/her authorized legal representative must understand the natureof the study. The subject's authorized legal representative must sign an informedconsent 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, andinternet connection.
Exclusion
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 orhistory of intolerance to omega-3 fatty acid, inositol or NAC after 2 months oftreatment 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.
Study Design
Connect with a study center
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
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