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

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-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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder; Autism; Non-verbal Learning Disorder
• Intervention / Treatment: Drug: Open-label Treatment with Omega-3 Fatty Acids + Inositol; Drug: Open-label Treatment with N-acetylcysteine

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hannah O'Connor, BS; Phone Number: 617-643-6617; Email: hgoconnor@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Principal Investigator: Janet Wozniak, MD
      • Contact: Abigail Farrell, BS; Phone Number: 617-643-6617; Email: aefarrell@partners.org
      • Contact: Haley Driscoll, BA; Phone Number: 617-724-2551; Email: hdriscoll2@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 15 years (Child)
• Accepts Healthy Volunteers: No

Description

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 195 on the Withdrawn + Social Problems + Thought Problems subscales.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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Omega-3 Fatty Acids + Inositol; Subjects will be treated with 1020mg QAM + 1020mg QPM of omega-3 fatty acids and inositol based on weight (subjects under 25kg: 1000mg QD; Subjects weighing 25kg or more: 2000mg QD).	Drug: Open-label Treatment with Omega-3 Fatty Acids + Inositol; Open-label Treatment with Omega-3 Fatty Acids + Inositol
Experimental: N-acetylcysteine; Subjects will be treated with N-acetylcysteine capsules (subjects ages 5-12: 1800mg QD; subjects ages 13-17: 2400 mg QD) or effervescent tablets (subjects ages 5-12: 1800mg QD; subjects ages 13-17: 2700 mg QD) based on age.	Drug: Open-label Treatment with N-acetylcysteine; Open-label Treatment with acetylcysteine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in the Parent-Young Mania Rating Scale (P-YMRS) Score	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.	Baseline to 6 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in the Parent-completed Children's Depression Inventory (CDI)	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.	Baseline to 6 Weeks
Mean Change in the NIMH Clinical Global Improvement scale (CGI)	The CGI is a measure of illness severity adapted for specific disorders. It allows rating of mania, depression and overall bipolar disorder illness, as well as other conditions frequently comorbid with bipolar disorder. The severity score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The improvement score ranges from 1 (very much improved) to 7 (very much worse).	Baseline to 6 Weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Demarest Lloyd Jr. Foundation
• Investigators: Principal Investigator: Janet Wozniak, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: November 27, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: autism; NAC; omega-3; learning disorder; natural supplements
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Communication Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Learning Disabilities; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Protective Agents; Micronutrients; Respiratory System Agents; Vitamins; Antioxidants; Antidotes; Vitamin B Complex; Free Radical Scavengers; Expectorants; Acetylcysteine; N-monoacetylcystine; Inositol
• Other Study ID Numbers: 2018P002261

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No