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| ID | Type | Description | Link |
|---|---|---|---|
| K99HD101702 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The goal of this study is to target the neurobiology of restricted and repetitive behaviors in children with autism spectrum disorder using N-acetylcysteine (NAC), a well-tolerated nutritional supplement that has shown promise for reducing symptom severity in recent small-scale trials. The findings from this research will shed light on the mechanisms of action underlying the clinical benefits of NAC and the effects of NAC on altering restricted and repetitive behavior symptom severity in children with autism spectrum disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-Acetylcysteine | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetylcysteine | Drug | 12 week administration of N-Acetylcysteine to target restricted repetitive behavior severity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in glutamatergic neurometabolites (Glx) measured by proton spectroscopy Magnetic Resonance Imaging (MRI) | Baseline and Week 12 of treatment | |
| Change in restricted and repetitive behaviors as measured by Children's Yale Brown Obsessive Compulsive Scale - Autism Spectrum Disorder (CYBOCS-ASD) | Higher scores on the Children's Yale Brown Obsessive Compulsive Scale - Autism Spectrum Disorder mean higher levels of restricted and repetitive behaviors (Raw Score Total Range: 0-20) | Screening, Week 8, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gamma band amplitude and synchronization measured by electroencephalography (EEG) | Baseline, Week 12 | |
| Change in restricted repetitive behavior subtypes as measured by the Restricted Behavior Scale - Revised (RBS-R) | Higher scores on the Repetitive Behavior Scale- Revised mean higher levels of repetitive and restricted behaviors. (Raw Score Total Range: 0 - 129) |
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Inclusion Criteria:
Exclusion criteria:
• the presence of significant medical problems that reduce medical stability.
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| Name | Affiliation | Role |
|---|---|---|
| John Hegarty, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
De-Identified data will be shared with the National Database for Autism Research (NDAR)
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The data will be submitted on January 15th and July 15th each year.
Researchers with access to the National Database for Autism Research (NDAR) will be able to obtain the submitted data
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Baseline, week 8, week 12 |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |