Last updated: March 15, 2024
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting
Phase
4
Condition
Autism
Autism Spectrum Disorder (Asd)
Asperger's Disorder
Treatment
Open-label Treatment with N-acetylcysteine
Open-label Treatment with Omega-3 Fatty Acids + Inositol
Clinical Study ID
NCT03757585
2018P002261
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 195 on the Withdrawn + Social Problems + Thought Problems subscales.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 and studycoordinator, 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 nature ofthe study. The subject's authorized legal representative must sign an informed consentdocument 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
Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Open-label Treatment with N-acetylcysteine
Phase: 4
Study Start date:
May 20, 2019
Estimated Completion Date:
July 31, 2024
Connect with a study center
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
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