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N-acetylcysteine

Omega-3 Fatty Acids + Inositol and N-acetylcysteine for Autism Spectrum Disorders

Phase 4
Recruiting
Led By Janet Wozniak, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 195 on the Withdrawn + Social Problems + Thought Problems subscales.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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 weeks
Awards & highlights

Study Summary

This trial will compare the effectiveness and safety of omega-3 fatty acids, inositol, and N-acetylcysteine in treating mood dysregulation in children and adolescents with NVLD or ASD.

Who is the study for?
This trial is for children and adolescents aged 5-17 with non-verbal learning disability (NVLD) or Autism Spectrum Disorder (ASD), who have trouble managing their emotions. They must be able to swallow pills, understand English well enough for study requirements, and use a computer with internet for remote assessments. Exclusions include an IQ below 70, certain medical conditions, risk of suicide, pregnancy, nursing mothers, or known sensitivity to the trial supplements.Check my eligibility
What is being tested?
The study tests natural treatments: Omega-3 fatty acids plus Inositol versus N-acetylcysteine (NAC) over six weeks to see which is better at helping kids with NVLD/ASD manage mood swings. It's an open-label trial where both researchers and participants know what treatment is being given.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort like nausea or diarrhea from Omega-3s; headaches or dizziness from Inositol; and possibly bad breath, constipation, or low blood pressure from NAC. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with non-verbal learning disability or Autism Spectrum Disorder, or have specific scores on a behavior checklist.
Select...
You have severe symptoms of anxiety, depression, aggression, and attention issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Change in the Parent-Young Mania Rating Scale (P-YMRS) Score
Secondary outcome measures
Mean Change in the NIMH Clinical Global Improvement scale (CGI)
Mean Change in the Parent-completed Children's Depression Inventory (CDI)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Omega-3 Fatty Acids + InositolExperimental Treatment1 Intervention
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 II: N-acetylcysteineExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,924 Previous Clinical Trials
13,193,363 Total Patients Enrolled
42 Trials studying Autism Spectrum Disorder
3,068 Patients Enrolled for Autism Spectrum Disorder
Demarest Lloyd Jr. FoundationUNKNOWN
Janet Wozniak, MDPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital
Joan And Stanford I. Weill Medical College Of Cornell Uni (Medical School)
Mass Gen Hospital (Residency)
9 Previous Clinical Trials
365 Total Patients Enrolled

Media Library

Open-label Treatment with N-acetylcysteine (N-acetylcysteine) Clinical Trial Eligibility Overview. Trial Name: NCT03757585 — Phase 4
Autism Spectrum Disorder Research Study Groups: Omega-3 Fatty Acids + Inositol, N-acetylcysteine
Autism Spectrum Disorder Clinical Trial 2023: Open-label Treatment with N-acetylcysteine Highlights & Side Effects. Trial Name: NCT03757585 — Phase 4
Open-label Treatment with N-acetylcysteine (N-acetylcysteine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03757585 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned open-label treatment with Omega-3 Fatty Acids and Inositol?

"Research conducted by Power suggests that Open-label Treatment with Omega-3 Fatty Acids + Inositol is highly safe and received a score of 3 due to its approval status as a Phase 4 trial."

Answered by AI

Does this research endeavor provide opportunities for those under 40 to participate?

"This trial is open to children between 5 and 17 years of age. Clinicialtrials.gov hosts 447 studies for pediatric patients, as well as 699 studies designed for elderly population groups."

Answered by AI

Is recruitment currently underway for this clinical experiment?

"Affirmative. The information on clinicaltrials.gov indicates that this experiment, which was first posted on May 20th 2019, is in the midst of actively seeking participants. Sixty individuals are needed to be recruited from a single medical establishment."

Answered by AI

What conditions can be ameliorated by Open-label Treatment with Omega-3 Fatty Acids + Inositol?

"Open-label Treatment with Omega-3 Fatty Acids + Inositol has become a common practice to treat corneal ulcerations, as well as acute rhinitis, acetaminophen poisoning, and other ocular maladies."

Answered by AI

May I participate in this medical experiment?

"To enter this trial, individuals must possess the diagnosis of autism and early infantile disorder and be aged between 5 to 17 years. This investigation is searching for 60 participants in total."

Answered by AI

What have prior research efforts revealed regarding the combination of omega-3 fatty acids and inositol for open-label treatment?

"As of today, 58 studies are underway to investigate the effects of Open-label Treatment with Omega-3 Fatty Acids + Inositol with 12 trials at Phase 3. Many centres in Boston, MA are running these tests but 81 other locations around the globe have experiments dedicated to this treatment."

Answered by AI

How many participants have been recruited to participate in this study?

"Affirmative. Clinicaltrials.gov data implies that this trial is presently recruiting participants; it was first posted on May 20th 2019 and last updated November 1st 2022. 60 patients are required from one medical centre for the study to commence."

Answered by AI

Who else is applying?

What state do they live in?
South Carolina
How old are they?
18 - 65
< 18
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~3 spots leftby Jul 2024