What side effects are associated with this type of intervention?

Common treatments for Autism Spectrum Disorder (ASD) such as Omega-3 Fatty Acids, Inositol, and N-acetylcysteine (NAC) have varying side effect profiles. Omega-3 Fatty Acids are generally well-tolerated but can cause gastrointestinal issues like diarrhea. Inositol, which modulates neurotransmitter signaling, has a benign side effect profile but may cause mild gastrointestinal discomfort. N-acetylcysteine (NAC), an antioxidant, and glutamate modulator, is also well-tolerated but can occasionally cause gastrointestinal disturbances and, in rare cases, allergic reactions. Overall, these treatments are considered to have low risk of harm.

What prior FDA approvals exist?

The FDA has approved two medications for the treatment of irritability associated with Autism Spectrum Disorder (ASD): risperidone and aripiprazole. These antipsychotic drugs help manage symptoms such as aggression, self-injury, and severe tantrums. While Omega-3 Fatty Acids, Inositol, and N-acetylcysteine (NAC) are being studied for their potential benefits in ASD due to their anti-inflammatory, neuroprotective, and neurotransmitter-modulating effects, they are not currently FDA-approved for this condition. Further research is needed to establish their efficacy and safety in treating ASD.

What other types of research exist?

Promising novel alternatives for ASD treatment in 2024 include: 1) Lacritin, a tear protein with potential neuroprotective effects, currently under investigation for dry eye but showing promise for broader applications; 2) Thymosin beta-4, a peptide with wound-healing and anti-inflammatory properties, which may offer neuroprotective benefits; 3) TOP1630, a narrow-spectrum kinase inhibitor targeting immune responses, potentially beneficial for neuroinflammation in ASD.

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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

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 6 weeks

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial tests natural supplements like omega-3 fatty acids, inositol, and NAC to help children and teens with NVLD or ASD who have mood issues. These supplements aim to improve brain health and reduce inflammation to stabilize their mood. Omega-3 fatty acids have been studied for their potential benefits in children with ASD, but results have been inconsistent.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Omega-3 Fatty Acids, Inositol, and N-acetylcysteine (NAC) are treatments studied for Autism Spectrum Disorder (ASD) due to their specific mechanisms of action. Omega-3 Fatty Acids provide anti-inflammatory and neuroprotective effects, which can help reduce neuroinflammation and support brain health. Inositol modulates neurotransmitter signaling, potentially balancing mood and improving behavioral symptoms by affecting serotonin and dopamine pathways. NAC acts as an antioxidant and modulates glutamate levels, reducing oxidative stress and excitotoxicity, which are often elevated in ASD. These mechanisms are crucial as they target underlying biological processes contributing to ASD symptoms, offering potential therapeutic benefits.

Dietary interventions for autism spectrum disorder: An updated systematic review of human studies.A randomised, double blind, placebo-controlled trial of a fixed dose of N-acetyl cysteine in children with autistic disorder.