A Study of N-Acetyl Cysteine in Children With Autism
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Purpose
The purpose of the study is to test the tolerability and efficacy of N-Acetyl Cysteine (NAC) in children with Autism. NAC is a compound that increases the levels of Glutathione, the body's main antioxidant. Glutathione is a compound in the blood that is part of a natural defense system (the antioxidant system). Anti-oxidants protect the body from damage caused by internal toxins called "free radicals." It is possible that children with Autism tend to have lower levels of glutathione, an important compound in our bodies that helps combat the effects of toxic free radicals.
We hope that by studying the antioxidant system in more detail, we will increase our understanding of the reasons why people develop Autism so that we can design better ways to treat individuals with this condition. This study is meant to test the safety tolerability of NAC and its effectiveness in the treatment of behavioral difficulties in children with autism. It will also examine the possible benefit of this agent in improving the core deficits in autism such as social deficits.
| Condition | Intervention | Phase |
|---|---|---|
|
Autistic Disorder |
Drug: N-Acetyl Cysteine Other: Placebo - sugar pill |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Double-blind , Randomized, Placebo Controlled Study of N-Acetyl Cysteine in Autism. |
- The Aberrant Behavior Checklist total score (ABC) [ Time Frame: 4, 8, and 12 weeks ] [ Designated as safety issue: No ]
- Dosage Record and Treatment Emergent Symptom Scale (DOTES) [ Time Frame: 4, 8, and 12 weeks ] [ Designated as safety issue: Yes ]
- : The Clinical Global Rating Scale (CGRS) Improvement subscale [ Time Frame: 4, 8, and 12 weeks ] [ Designated as safety issue: Yes ]
- GSH levels in peripheral blood, measured by state-of-the-art high-performance liquid chromatography (HPLC) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Social Responsiveness Scale (SRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Sensory Profile Questionnaire (SPQ) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Irritability subscale of the ABC [ Time Frame: 4, 8, and 12 weeks ] [ Designated as safety issue: No ]
- GSH metabolism intermediates in peripheral blood measured by HPLC [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2008 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: N-Acetyl Cysteine
active compound N-Acetyl Cysteine
|
Drug: N-Acetyl Cysteine
Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks Entire intervention lasts for 12 weeks (drug administration is continuous). |
|
Placebo Comparator: Sugar pill
Placebo or sugar pill
|
Other: Placebo - sugar pill
Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks Entire intervention lasts for 12 weeks (drug administration is continuous). |
Eligibility| Ages Eligible for Study: | 3 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Outpatients between 3.0 and 12.11 years of age inclusive
- Males and females who are physically healthy
- diagnosis of autism based DSM-IV- TR criteria, the Autism Diagnostic Interview-Revised, and expert clinical evaluation
- CGI Severity rating of 4
- Care provider who can reliably bring subject to clinic visits, can provide trustworthy ratings, and interacts with subject on a regular basis
- Ability of subject to swallow the compound
- Stable concomitant medications for at least 2 weeks
- No planned changes in psychosocial interventions during the open-label NAC trial
Exclusion Criteria:
- DSM-IV-TR diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder NOS
- Prior adequate trial of NAC
- Active medical problems: unstable seizures, significant physical illness (e.g., serious liver or renal pathology)
- Pregnancy or sexually active females
- Subjects taking antioxidant agents and GSH prodrugs will be excluded from the study except if they have been off these compounds for at least 4 weeks
Contacts and Locations| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| Principal Investigator: | Antonio Hardan | Stanford University |
| Sub-Investigator: | Rabin Tirouvanziam PhD | Stanford University |
More Information
No publications provided by Stanford University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Antonio Hardan, Stanford University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00627705 History of Changes |
| Other Study ID Numbers: | SU-02012008-995, 10142 |
| Study First Received: | February 22, 2008 |
| Last Updated: | July 20, 2011 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders Acetylcysteine N-monoacetylcystine Antiviral Agents Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes |
ClinicalTrials.gov processed this record on May 23, 2013