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| Name | Class |
|---|---|
| Cumberland Pharmaceuticals | INDUSTRY |
| Norton Healthcare | OTHER |
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This is a double-blind, placebo-controlled crossover study to evaluate the safety and efficacy of glutathione alone or glutathione, vitamin C and NAC treatment in children with autism who also have severe behavior problems. The investigators hypothesis is that children with autism will show improvement in both learning capabilities and behavior with either glutathione, or glutathione, vitamin C and NAC therapy.
This is a prospective, single center, double-blind, randomized pilot study in children and adolescents with autism and severe behavior disorders. All subjects will undergo initial screening procedures to determine eligibility. They will then be randomized to either 8 weeks of placebo or 8 weeks of glutathione or glutathione, vitamin C and N-acetylcysteine. They will receive intravenous treatment weekly and will have ongoing behavioral studies during this period. Following 8 weeks of therapy, they will have a week without treatment then will cross-over to the alternate therapy for weekly intravenous infusions and behavioral testing. In addition to baseline hematology and chemistries, baseline oxidized and reduced glutathione will be measured. These parameters will be repeated at the end of each 8 week course of therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Randomized to placebo or treatment (glutathione or glutathione/vit C/NAC) |
|
| Glutathione | Active Comparator | Randomized to placebo or treatment (glutathione or glutathione/vit C/NAC) |
|
| Glutathione, Vit C and NAC | Active Comparator | Randomized to placebo or treatment (glutathione or glutathione/vit C/NAC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | 50 mL of 1/2 normal saline IV |
| |
| glutathione |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in both developmental skills and behavior with either glutathione or glutathione, Vitamin C and N-acetylcysteine therapy as compared to placebo therapy. Subjects will also be monitored using clinical and laboratory safety parameters. | Improvement in both developmental skills and behavior measured using validated scales in subjects receiving either glutathione, glutathione/Vitamin C/N-acetylcysteine or placebo measured at baseline, 9 weeks and at the end of study in a double-blind cross-over design. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response to glutathione (changes in behavior) will correlate with the glutathione level (GSH) and GSH:GSSG ratio | Baseline | |
| Response to glutathione (changes in behavior) will correlate with the glutathione level (GSH) and GSH:GSSG ratio | 9 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia G. Williams, MD | University of Louisville | Principal Investigator |
| Janice E. Sullivan, M.D. | University of Louisville | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KCPCRU | Louisville | Kentucky | 40202 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 14, 2022 | |
| Reset | May 10, 2022 | |
| Release | Apr 5, 2024 | |
| Reset | May 1, 2024 | |
| Release | Jul 11, 2024 | |
| Reset | Aug 6, 2024 | |
| Release | Jun 26, 2025 | |
| Reset | Jul 14, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 14, 2022 | May 10, 2022 | |||
| Apr 5, 2024 |
| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
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| ID | Term |
|---|---|
| D005978 | Glutathione |
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013400 | Sugar Acids |
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| Drug |
glutathione 600 mg IV |
|
| glutathione, vit C and NAC | Drug | Glutathione 600 mg IV Vitamin C 2000 mg IV N-acetylcysteine 20 mg/kg IV (max dose = 600 mg) Mix above three in 1/2 NS for a total volume of 50 mL |
|
|
| Response to glutathione (changes in behavior) will correlate with the glutathione level (GSH) and GSH:GSSG ratio | 18 weeks |
| May 1, 2024 |
| Jul 11, 2024 | Aug 6, 2024 |
| Jun 26, 2025 | Jul 14, 2025 |
| D000144 |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |