Trial · NCT00627705
A Study of N-Acetyl Cysteine in Children With Autism
NCT00627705, Phase 2, Completed, Stanford University; results first posted 2017-05-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of N-Acetyl Cysteine in Children With Autism. Trials, record NCT00627705. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00627705
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of N-Acetyl Cysteine in Children With Autism
- NCT number
- NCT00627705
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 43 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Autistic Disorder
- Interventions
- N-Acetyl Cysteine, Placebo - sugar pill
- First posted
- 2008-03-03
- Last updated
- 2017-05-18
- Results first posted
- 2017-05-18
- Limitations and caveats
The sample size was relatively small and the age range was narrow, which limits the generalizability of the findings. Most subjects were taking psychotropic medications and were receiving behavioral interventions.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Number of Subjects With Reported Side Effects as Assessed by Dosage Record and Treatment Emergent Symptom Scale (DOTES) | 4, 8, and 12 weeks | The Dosage Record and Treatment Emergent Symptom Scale (DOTES) provides information on the presence, frequency, and severity of side effects reported during the course of the trial. |
| Primary | The Clinical Global Rating Scale (CGRS) Improvement Subscale Score | 12 weeks | Score range 1-7 (lower score mean more improvement compared to baseline) |
| Primary | Glutathione (GSH) Levels in Peripheral Blood, Measured by State-of-the-art High-performance Liquid Chromatography (HPLC) | 12 weeks | Data not collected. The laboratory was not able to measure Glutathione levels. |
| Primary | Irritability Subscale of the Aberrant Behavior Checklist (ABC) | baseline and 12 weeks | Aberrant Behavior Checklist (ABC) Irritability Subscale Score (range 0-45); higher scores mean higher irritability |
| Secondary | The Aberrant Behavior Checklist Total Score (ABC) | 4, 8, and 12 weeks | Total score was not analyzed since we analyzed the sub scales. Additionally, the authors of the instrument do not recommend analyzing the total score. |
| Secondary | Social Responsiveness Scale (SRS) | 12 weeks | SRS total score (range 0-195); higher scores mean more social impairment |
| Secondary | Sensory Profile Questionnaire (SPQ) | 12 weeks | |
| Secondary | Glutathione (GSH) Metabolism Intermediates in Peripheral Blood | 12 weeks |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Number of Subjects With Reported Side Effects as Assessed by Dosage Record and Treatment Emergent Symptom Scale (DOTES) | 4, 8, and 12 weeks | We analyzed subjects who had follow-up data available. | participants | NUMBER |
| PRIMARY | The Clinical Global Rating Scale (CGRS) Improvement Subscale Score | 12 weeks | We analyzed subjects who had follow-up data available. | score (range 1-7) | MEAN |
| PRIMARY | Glutathione (GSH) Levels in Peripheral Blood, Measured by State-of-the-art High-performance Liquid Chromatography (HPLC) | 12 weeks | Data not collected. | ||
| PRIMARY | Irritability Subscale of the Aberrant Behavior Checklist (ABC) | baseline and 12 weeks | We analyzed subjects who had follow-up data available. | Score (range 0-45) | MEAN |
| SECONDARY | The Aberrant Behavior Checklist Total Score (ABC) | 4, 8, and 12 weeks | Measure not analyzed. | ||
| SECONDARY | Social Responsiveness Scale (SRS) | 12 weeks | We analyzed subjects who had follow-up data available. | SRS total score (range 0-195) | MEAN |
| SECONDARY | Sensory Profile Questionnaire (SPQ) | 12 weeks | Data not collected. Measure not analyzed. | ||
| SECONDARY | Glutathione (GSH) Metabolism Intermediates in Peripheral Blood | 12 weeks | Data not collected. The measure was not analyzed. The lab was not able to measure Glutathione for the study. |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Number of Subjects With Reported Side Effects as Assessed by Dosage Record and Treatment Emergent Symptom Scale (DOTES) | N-Acetyl Cysteine | Total Number of Subjects with GI adverse Events | 11 | participants | |
| Total Number of Subjects With Reported Side Effects as Assessed by Dosage Record and Treatment Emergent Symptom Scale (DOTES) | Sugar Pill | Total Number of Subjects with GI adverse Events | 7 | participants | |
| Total Number of Subjects With Reported Side Effects as Assessed by Dosage Record and Treatment Emergent Symptom Scale (DOTES) | N-Acetyl Cysteine | Constipation | 3 | participants | |
| Total Number of Subjects With Reported Side Effects as Assessed by Dosage Record and Treatment Emergent Symptom Scale (DOTES) | Sugar Pill | Constipation | 2 | participants | |
| Total Number of Subjects With Reported Side Effects as Assessed by Dosage Record and Treatment Emergent Symptom Scale (DOTES) | N-Acetyl Cysteine | Nausea/Vomiting | 6 | participants | |
| Total Number of Subjects With Reported Side Effects as Assessed by Dosage Record and Treatment Emergent Symptom Scale (DOTES) | Sugar Pill | Nausea/Vomiting | 3 | participants | |
| Total Number of Subjects With Reported Side Effects as Assessed by Dosage Record and Treatment Emergent Symptom Scale (DOTES) | N-Acetyl Cysteine | Diarrhea | 3 | participants | |
| Total Number of Subjects With Reported Side Effects as Assessed by Dosage Record and Treatment Emergent Symptom Scale (DOTES) | Sugar Pill | Diarrhea | 1 | participants | |
| Total Number of Subjects With Reported Side Effects as Assessed by Dosage Record and Treatment Emergent Symptom Scale (DOTES) | N-Acetyl Cysteine | Increased Appetite | 2 | participants | |
| Total Number of Subjects With Reported Side Effects as Assessed by Dosage Record and Treatment Emergent Symptom Scale (DOTES) | Sugar Pill | Increased Appetite | 0 | participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | N-Acetyl Cysteine | 15 | |
| Overall Study | STARTED | Sugar Pill | 18 | |
| Overall Study | COMPLETED | N-Acetyl Cysteine | 13 | |
| Overall Study | COMPLETED | Sugar Pill | 12 | |
| Overall Study | NOT COMPLETED | N-Acetyl Cysteine | 2 | |
| Overall Study | NOT COMPLETED | Sugar Pill | 6 |
Source ClinicalTrials.gov
Adverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | N-Acetyl Cysteine | 3 | 14 | 3 |
| other | Constipation | Gastrointestinal disorders | Sugar Pill | 2 | 15 | 2 |
| other | Nausea/Vomiting | Gastrointestinal disorders | N-Acetyl Cysteine | 6 | 14 | 6 |
| other | Nausea/Vomiting | Gastrointestinal disorders | Sugar Pill | 3 | 15 | 3 |
| other | Diarrhea | Gastrointestinal disorders | N-Acetyl Cysteine | 3 | 14 | 3 |
| other | Diarrhea | Gastrointestinal disorders | Sugar Pill | 1 | 15 | 1 |
| other | Increased Appetite | Gastrointestinal disorders | N-Acetyl Cysteine | 2 | 14 | 2 |
| other | Increased Appetite | Gastrointestinal disorders | Sugar Pill | 0 | 15 | 0 |
| other | Decreased Appetite | Gastrointestinal disorders | N-Acetyl Cysteine | 2 | 14 | 2 |
| other | Decreased Appetite | Gastrointestinal disorders | Sugar Pill | 3 | 15 | 3 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | N-Acetyl Cysteine | ||
| Total, all-cause mortality | Sugar Pill | ||
| Total, other adverse events | N-Acetyl Cysteine | 13 | 14 |
| Total, other adverse events | Sugar Pill | 14 | 15 |
| Total, serious adverse events | N-Acetyl Cysteine | 0 | 14 |
| Total, serious adverse events | Sugar Pill | 0 | 15 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22342106 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| N-Acetyl Cysteine vs Sugar Pill: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00627705
GET https://conductscience.org/api/trials/v1/NCT00627705/results?page=2