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

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ClinicalTrials.gov Identifier: NCT03757585
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : June 19, 2019
Sponsor:
Collaborator:
Demarest Lloyd Jr. Foundation
Information provided by (Responsible Party):
Janet Wozniak, MD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Non-verbal Learning Disorder Autism Spectrum Disorder Autism Drug: Open-label Treatment with Omega-3 Fatty Acids + Inositol Drug: Open-label Treatment with N-acetylcysteine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : May 20, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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.


Secondary Outcome Measures :
  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 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).



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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757585


Contacts
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Contact: Abigail Farrell, BS 617-643-6617 aefarrell@partners.org
Contact: Haley Driscoll, BA 617-724-2551 hdriscoll2@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Abigail Farrell, BS    617-643-6617    aefarrell@partners.org   
Contact: Haley Driscoll, BA    617-724-2551    hdriscoll2@mgh.harvard.edu   
Principal Investigator: Janet Wozniak, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Demarest Lloyd Jr. Foundation
Investigators
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Principal Investigator: Janet Wozniak, MD Massachusetts General Hospital

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Responsible Party: Janet Wozniak, MD, Assistant Professor of Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03757585     History of Changes
Other Study ID Numbers: 2018P002261
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janet Wozniak, MD, Massachusetts General Hospital:
autism
learning disorder
natural supplements
NAC
omega-3

Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Learning Disorders
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetylcysteine
N-monoacetylcystine
Inositol
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Vitamin B Complex
Vitamins
Micronutrients
Nutrients