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NCT00453180 · ClinicalTrials.gov registry record · Phase 2
A Study of Oral N-Acetylcysteine in Children With Autism Spectrum Disorders
A Phase 2 study of Autistic Disorder and Asperger Syndrome, sponsored by Indiana University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT00453180: Completed Phase 2 study of Autistic Disorder and Asperger Syndrome, sponsored by Indiana University School of Medicine.
NCT00453180 is a Phase 2 study of Autistic Disorder and Asperger Syndrome that has completed, run by Indiana University School of Medicine. The registered enrollment target is 31 participants, below the 112-participant average among 27 other Autistic Disorder trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00453180, a Phase 2 study of Autistic Disorder and Asperger Syndrome, has completed, sponsored by Indiana University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine whether treatment with oral N-acetylcysteine (NAC) will improve behavior problems often associated with autism spectrum disorders.
Primary Outcome
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extr
Conditions Studied
Interventions
- DRUG Placebo
- DRUG N-acetylcysteine
Study Locations (1)
Indiana
- Riley Hospital, Riley Child and Adolescent Psychiatry Clinic - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2007-03 |
| Est. Completion | 2009-11 |
| Phase | Phase 2 |
What the finished NCT00453180 record still lists
NCT00453180 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 112-participant average among 27 other Autistic Disorder trials with a reported enrollment target (72% lower).
The record links to 3 conditions, with Autistic Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00453180 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT00453180 about?
NCT00453180 is a clinical study titled "A Study of Oral N-Acetylcysteine in Children With Autism Spectrum Disorders". The purpose of this study is to determine whether treatment with oral N-acetylcysteine (NAC) will improve behavior problems often associated with autism spectrum disorders.
What is the current status of trial NCT00453180?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2007-03. Estimated completion is 2009-11.
What conditions does trial NCT00453180 study?
This clinical trial studies the following conditions: Autistic Disorder, Asperger Syndrome, Child Development Disorders, Pervasive.
What interventions are being tested in trial NCT00453180?
The interventions under investigation include: Placebo (DRUG), N-acetylcysteine (DRUG).
Who is sponsoring clinical trial NCT00453180?
This trial is sponsored by Indiana University School of Medicine, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00453180 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autistic Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00453180's enrollment target sits among peer trials
31 25th of 27 higher than 3 of 27 other Autistic Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autistic Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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COMPASS Across Settings (CAST) for Improving Transition Outcomes for Students With ASD
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