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Completed

NCT Number: NCT03757585

Natural Treatments 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-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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 195 on the Withdrawn + Social Problems + Thought Problems subscales.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.
  • Weighs less than 12.5kg.

Treatment and study plan

Open-label Treatment with Omega-3 Fatty Acids + Inositol

Drug

Open-label Treatment with Omega-3 Fatty Acids + Inositol

Open-label Treatment with N-acetylcysteine

Drug

Open-label Treatment with acetylcysteine

Primary outcomes

  1. Mean Change in the Parent-Young Mania Rating Scale (P-YMRS) Score

    Time frame: Baseline to 6 Weeks

    The YMRS consists of 11 items rated on a scale from 0 (symptoms not present) to 4 (symptoms extremely severe). It is used to assess manic symptoms. The YMRS score ranges from 0-60. Questions are asked about the last week. This scale is generally accepted as the main outcome measure in studies of pediatric bipolar disorder and is linked directly to the core symptoms of mania. Higher scores indicate more severe manic symptoms.

Secondary outcomes

  1. Mean Change in the Parent-completed Children's Depression Inventory (CDI)

    Time frame: Baseline to 6 Weeks

    The CDI consists of 27 items quantifying symptoms such as depressed mood, hedonic capacity, vegetative functions, self-evaluation, and interpersonal behaviors. Each item consists of three statements graded in order of increasing severity from 0 to 2; parents select the one that characterized their child's symptoms best during the past 1 week. The item scores are combined into a total depression score, which ranges from 0 to 54. A higher CDI score means a higher depressive state.

  2. Mean Change in the NIMH Clinical Global Improvement Scale (CGI)

    Time frame: Baseline to 6 Weeks

    The CGI-BPD-S is a clinician-rated measure of bipolar disorder severity. Severity scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The outcome reported reflects the change from baseline in CGI-BPD-S scores and negative scores represent improvement (i.e., decrease in severity from baseline).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Demarest Lloyd Jr. Foundation

Registry information

Official study title

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)

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Nov 29, 2018
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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