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Omega-3 Fatty Acids + Inositol and N-acetylcysteine for Autism Spectrum Disorders
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You must be able to swallow pills.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.You are currently diagnosed with or have symptoms of psychosis.You have been diagnosed with non-verbal learning disability or Autism Spectrum Disorder, or have specific scores on a behavior checklist.You have a history of bleeding problems, including von Willebrand disease.You have thyroid problems that have not been treated.You have been diagnosed with schizophrenia.You have severe symptoms of anxiety, depression, aggression, and attention issues.You have been diagnosed with non-verbal learning disability (NVLD) or Autism Spectrum Disorder, or have high scores on certain behavior checklists.You have a severe or unstable illness affecting your liver, kidneys, stomach, lungs, heart, hormones, nerves, immune system, or blood.You have a history of using, abusing, or being dependent on substances listed in the DSM-IV.You are considered to be at high risk for suicide based on a clinical assessment.You have had a bad reaction to omega-3 fatty acids, inositol, or NAC in the past.You have severe allergies or have had bad reactions to multiple medications.
- Group 1: Omega-3 Fatty Acids + Inositol
- Group 2: N-acetylcysteine
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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