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

Overseen By Hannah O'Connor, BS

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Massachusetts General Hospital

Disqualifiers: Serious illness, Bleeding disorders, Seizure disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the combination of Omega-3 Fatty Acids, Inositol, and N-acetylcysteine safe for humans?

N-acetylcysteine (NAC) has been studied for safety in people with autism, showing it is generally well-tolerated. However, there is insufficient evidence to determine the safety of Omega-3 fatty acids specifically for autism, and no specific safety data for the combination of Omega-3 Fatty Acids, Inositol, and NAC together. ^{1 2 3 4 5}

How does the treatment with Omega-3 Fatty Acids, Inositol, and N-acetylcysteine differ from other treatments for Autism Spectrum Disorders?

This treatment is unique because it combines Omega-3 fatty acids, which may help improve social interaction and repetitive behaviors, with Inositol and N-acetylcysteine, which are not commonly used together for Autism Spectrum Disorders. The combination aims to address potential deficits in essential fatty acids and provide antioxidant support, which is a novel approach compared to standard treatments. ^{2 6 7 8 9}

What data supports the effectiveness of the drug N-acetylcysteine for autism spectrum disorders?

Research shows that N-acetylcysteine (NAC) may help reduce irritability and improve social impairment in individuals with autism spectrum disorders. Several studies have found NAC to be potentially effective when used alongside other treatments, although more research is needed to confirm these findings. ^{1 2 3 5 10}

Who Is on the Research Team?

Janet Wozniak, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have been diagnosed with non-verbal learning disability or Autism Spectrum Disorder, or have specific scores on a behavior checklist.

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.

You have severe symptoms of anxiety, depression, aggression, and attention issues.

Exclusion Criteria

Your IQ is less than 70.

You weigh less than 12.5 kilograms.

You have a seizure disorder that is not under control or not being treated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive omega-3 fatty acids, inositol, or N-acetylcysteine for mood dysregulation over a 6-week period

6 weeks

Conducted via telepsychiatry

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Open-label Treatment with N-acetylcysteine
• Open-label Treatment with Omega-3 Fatty Acids + Inositol

Trial Overview 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.

How Is the Trial Designed?

Group I: Omega-3 Fatty Acids + Inositol Experimental Treatment 1 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-acetylcysteine Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Demarest Lloyd Jr. Foundation

Collaborator

Trials

1

Recruited

60+

Published Research Related to This Trial

N-acetylcysteine (NAC) combined with risperidone significantly reduced irritability in children and adolescents with autism spectrum disorders (ASD) over an 8-week period, compared to risperidone with a placebo.

The treatment was generally well-tolerated, with only mild adverse effects reported, such as constipation and increased appetite, and no serious side effects were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized double blind placebo controlled clinical trial of N-Acetylcysteine added to risperidone for treating autistic disorders. Ghanizadeh, A., Moghimi-Sarani, E.[2022]

In a 10-week clinical trial involving 40 children aged 4 to 12 with autistic disorders, N-acetylcysteine (NAC) was found to significantly reduce irritability and hyperactivity when used alongside risperidone.

The study suggests that NAC can be a beneficial adjunct therapy for managing symptoms of autistic disorders, enhancing the effectiveness of standard treatment with risperidone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

N-acetylcysteine as an adjunctive therapy to risperidone for treatment of irritability in autism: a randomized, double-blind, placebo-controlled clinical trial of efficacy and safety. Nikoo, M., Radnia, H., Farokhnia, M., et al.[2022]

N-acetylcysteine supplementation for 8-12 weeks showed significant improvements in hyperactivity, irritability, and social awareness in children with autism spectrum disorder, indicating its potential efficacy as a treatment option.

The treatment was found to be safe and well-tolerated, but further research is needed to confirm these findings before making broad recommendations for its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of N-acetylcysteine in autism spectrum disorders: A meta-analysis of randomized controlled trials. Lee, TM., Lee, KM., Lee, CY., et al.[2022]

In a 12-week study involving 31 youth with autism spectrum disorder (ASD), oral N-acetylcysteine (NAC) was well tolerated and successfully increased blood levels of glutathione, an important antioxidant.

However, NAC did not show a significant improvement in social impairment compared to placebo, indicating that while it may have some biological effects, it does not translate to clinical efficacy in treating core symptoms of ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized placebo-controlled pilot study of N-acetylcysteine in youth with autism spectrum disorder. Wink, LK., Adams, R., Wang, Z., et al.[2018]

A case study of a child with autism showed significant improvement in symptoms after taking oral N-acetylcysteine at a dosage of 800 mg/day for two months, with notable increases in social interaction.

The child's social impairment score decreased from 10 to 6, and aggressive behaviors dropped from 10 to 3, suggesting that N-acetylcysteine may help alleviate certain autism symptoms, potentially due to its role in reducing oxidative stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

N-acetylcysteine for treatment of autism, a case report. Ghanizadeh, A., Derakhshan, N.[2021]

In a pilot study involving 10 children aged 4-7 with autism spectrum disorder (ASD), 8 out of 9 participants who completed the study showed about a 33% improvement in autism symptoms after taking 1 gram of omega-3 fatty acids daily for 12 weeks.

The study found omega-3 fatty acids to be safe, with no reported side effects, suggesting they may be a beneficial intervention for children with ASD, although further research with larger groups is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega 3 fatty acid treatment in autism. Meiri, G., Bichovsky, Y., Belmaker, RH.[2009]

Citations

1. England pubmed.ncbi.nlm.nih.gov

A randomized double blind placebo controlled clinical trial of N-Acetylcysteine added to risperidone for treating autistic disorders. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Omega-3 fatty acids for autistic spectrum disorder: a systematic review. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

N-acetylcysteine as an adjunctive therapy to risperidone for treatment of irritability in autism: a randomized, double-blind, placebo-controlled clinical trial of efficacy and safety. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of N-acetylcysteine in autism spectrum disorders: A meta-analysis of randomized controlled trials. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A randomized placebo-controlled pilot study of N-acetylcysteine in youth with autism spectrum disorder. [2018]

6. India pubmed.ncbi.nlm.nih.gov

N-acetylcysteine for treatment of autism, a case report. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Mice prenatally exposed to valproic acid do not show autism-related disorders when fed with polyunsaturated fatty acid-enriched diets. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Omega-3 fatty acids supplementation for autism spectrum disorders (ASD). [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Omega 3 fatty acid treatment in autism. [2009]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Relationship between Long Chain n-3 Polyunsaturated Fatty Acids and Autism Spectrum Disorder: Systematic Review and Meta-Analysis of Case-Control and Randomised Controlled Trials. [2018]