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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)

Primary Purpose

Non-verbal Learning Disorder, Autism Spectrum Disorder, Autism

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

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

Open-label Treatment with N-acetylcysteine

About this trial

This is an interventional treatment trial for Non-verbal Learning Disorder focused on measuring autism, learning disorder, natural supplements, NAC, omega-3

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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 195 on the Withdrawn + Social Problems + Thought Problems subscales.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

Sites / Locations

Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Omega-3 Fatty Acids + Inositol

N-acetylcysteine

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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).

Full Information

NCT ID

NCT03757585

First Posted

November 27, 2018

Last Updated

November 1, 2022

Sponsor

Massachusetts General Hospital

Collaborators

Demarest Lloyd Jr. Foundation

1. Study Identification

Unique Protocol Identification Number

NCT03757585

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 20, 2019 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

Demarest Lloyd Jr. Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-verbal Learning Disorder, Autism Spectrum Disorder, Autism

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Omega-3 Fatty Acids + Inositol

Arm Type

Experimental

Arm Description

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).

Arm Title

N-acetylcysteine

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Open-label Treatment with N-acetylcysteine

Intervention Description

Open-label Treatment with acetylcysteine

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline to 6 Weeks

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline to 6 Weeks

Title

Mean Change in the NIMH Clinical Global Improvement scale (CGI)

Description

Time Frame

Baseline to 6 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hannah O'Connor, BS

Phone

617-643-6617

hgoconnor@mgh.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janet Wozniak, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Abigail Farrell, BS

Phone

617-643-6617

aefarrell@partners.org

First Name & Middle Initial & Last Name & Degree

Haley Driscoll, BA

Phone

617-724-2551

hdriscoll2@mgh.harvard.edu

First Name & Middle Initial & Last Name & Degree

Janet Wozniak, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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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