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

NCT ID: NCT03757585

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-20
• Study Completion Date: 2024-05-06

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Open-label Treatment with N-acetylcysteine

Intervention Type: DRUG

Open-label Treatment with acetylcysteine

Interventions

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

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

Intervention Type: DRUG

Open-label Treatment with N-acetylcysteine

Open-label Treatment with acetylcysteine

Intervention Type: DRUG

Eligibility Criteria

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 195 on the Withdrawn + Social Problems + Thought Problems subscales.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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Demarest Lloyd Jr. Foundation

UNKNOWN

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Janet Wozniak, MD

Assistant Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janet Wozniak, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2018P002261

Identifier Type: -

Identifier Source: org_study_id