Natural Treatments for the Management of Emotional Dysregulation in Youth With Non-verbal Learning Disability (NVLD) and/or Autism Spectrum Disorders (ASD)

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

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 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.

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 195 on the Withdrawn + Social Problems + Thought Problems subscales.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 States

    Active - Recruiting

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