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

NCT03757585 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2018P002261
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-verbal Learning Disorder; Autism Spectrum Disorder; Autism

Keywords

autism; learning disorder; natural supplements; NAC; omega-3

Outcome Measures

Primary Outcomes (1)

• 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. Higher scores indicate more severe manic symptoms.

  Baseline to 6 Weeks

Secondary Outcomes (2)

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

  Baseline to 6 Weeks

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

  Baseline to 6 Weeks

Study Arms (2)

Omega-3 Fatty Acids + Inositol

EXPERIMENTAL

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

N-acetylcysteine

EXPERIMENTAL

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

Interventions

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

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

Omega-3 Fatty Acids + Inositol

Open-label Treatment with N-acetylcysteine DRUG

Open-label Treatment with acetylcysteine

N-acetylcysteine

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Demarest Lloyd Jr. Foundation: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Learning Disabilities

Interventions

Fatty Acids, Omega-3; Inositol; Acetylcysteine

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Janet Wozniak
• Organization: Massachusetts General Hospital

jwozniak@partners.org

6176436617

Study Officials

• Janet Wozniak, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 29, 2018
• Study Start: May 20, 2019
• Primary Completion: May 6, 2024
• Study Completion: May 6, 2024
• Last Updated: June 5, 2025
• Results First Posted: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)