Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-01-11 @ 2:12 PM
Study NCT ID:
NCT00627705
Status:
COMPLETED
Last Update Posted:
2017-05-18
First Post:
2008-02-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of N-Acetyl Cysteine in Children With Autism
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}], 'ancestors': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hardanay@stanford.edu', 'phone': '650-736-1235', 'title': 'Antonio Hardan, MD', 'organization': 'Stanford University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '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.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline and 4, 8 and 12 Weeks', 'description': 'We analyzed all subjects who had follow-up data available.', 'eventGroups': [{'id': 'EG000', 'title': 'N-Acetyl Cysteine', 'description': 'active compound N-Acetyl Cysteine\n\nN-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\n\nEntire intervention lasts for 12 weeks (drug administration is continuous).', 'otherNumAtRisk': 14, 'otherNumAffected': 13, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sugar Pill', 'description': 'Placebo or sugar pill\n\nPlacebo - 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\n\nEntire intervention lasts for 12 weeks (drug administration is continuous).', 'otherNumAtRisk': 15, 'otherNumAffected': 14, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea/Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Excitement/ Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Motor Activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope/Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depressive Affect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Salivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sweating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Number of Subjects With Reported Side Effects as Assessed by Dosage Record and Treatment Emergent Symptom Scale (DOTES)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-Acetyl Cysteine', 'description': 'active compound N-Acetyl Cysteine\n\nN-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\n\nEntire intervention lasts for 12 weeks (drug administration is continuous).'}, {'id': 'OG001', 'title': 'Sugar Pill', 'description': 'Placebo or sugar pill\n\nPlacebo - 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\n\nEntire intervention lasts for 12 weeks (drug administration is continuous).'}], 'classes': [{'title': 'Total Number of Subjects with GI adverse Events', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Constipation', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Nausea/Vomiting', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Increased Appetite', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Decreased Appetite', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Akathisia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Excitement/Agitation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Increased Motor Activity', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Tremor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Syncope/Dizziness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Depressive Affect', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nasal Congestion', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Increased Salivation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Sweating', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4, 8, and 12 weeks', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'We analyzed subjects who had follow-up data available.'}, {'type': 'PRIMARY', 'title': 'The Clinical Global Rating Scale (CGRS) Improvement Subscale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-Acetyl Cysteine', 'description': 'active compound N-Acetyl Cysteine\n\nN-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\n\nEntire intervention lasts for 12 weeks (drug administration is continuous).'}, {'id': 'OG001', 'title': 'Sugar Pill', 'description': 'Placebo or sugar pill\n\nPlacebo - 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\n\nEntire intervention lasts for 12 weeks (drug administration is continuous).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.449', 'groupIds': ['OG000', 'OG001'], 'groupDescription': "Cohen's d = 0.30", 'statisticalMethod': 'mixed effects regression models', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'F= 0.81'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Score range 1-7 (lower score mean more improvement compared to baseline)', 'unitOfMeasure': 'score (range 1-7)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We analyzed subjects who had follow-up data available.'}, {'type': 'PRIMARY', 'title': 'Glutathione (GSH) Levels in Peripheral Blood, Measured by State-of-the-art High-performance Liquid Chromatography (HPLC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-Acetyl Cysteine', 'description': 'active compound N-Acetyl Cysteine\n\nN-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\n\nEntire intervention lasts for 12 weeks (drug administration is continuous).'}, {'id': 'OG001', 'title': 'Sugar Pill', 'description': 'Placebo or sugar pill\n\nPlacebo - 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\n\nEntire intervention lasts for 12 weeks (drug administration is continuous).'}], 'timeFrame': '12 weeks', 'description': 'Data not collected. The laboratory was not able to measure Glutathione levels.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected.'}, {'type': 'PRIMARY', 'title': 'Irritability Subscale of the Aberrant Behavior Checklist (ABC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-Acetyl Cysteine', 'description': 'active compound N-Acetyl Cysteine\n\nN-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\n\nEntire intervention lasts for 12 weeks (drug administration is continuous).'}, {'id': 'OG001', 'title': 'Sugar Pill', 'description': 'Placebo or sugar pill\n\nPlacebo - 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\n\nEntire intervention lasts for 12 weeks (drug administration is continuous).'}], 'classes': [{'title': 'Baseline ABC-I Score', 'categories': [{'measurements': [{'value': '16.9', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '9.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 ABC-I Score', 'categories': [{'measurements': [{'value': '7.2', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '13.1', 'spread': '9.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Aberrant Behavior Checklist irritability subscale (F = 6.80; p = \\<.001; d = .96).', 'groupDescription': "F values were derived from the interaction of participant group (NAC vs. placebo) and time (week) in mixed effects regression models. Cohen's d was computed based on the standardized mean difference in the change from baseline to week 12.", 'statisticalMethod': 'Mixed effects regression models', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12 weeks', 'description': 'Aberrant Behavior Checklist (ABC) Irritability Subscale Score (range 0-45); higher scores mean higher irritability', 'unitOfMeasure': 'Score (range 0-45)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We analyzed subjects who had follow-up data available.'}, {'type': 'SECONDARY', 'title': 'The Aberrant Behavior Checklist Total Score (ABC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-Acetyl Cysteine', 'description': 'active compound N-Acetyl Cysteine\n\nN-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\n\nEntire intervention lasts for 12 weeks (drug administration is continuous).'}, {'id': 'OG001', 'title': 'Sugar Pill', 'description': 'Placebo or sugar pill\n\nPlacebo - 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\n\nEntire intervention lasts for 12 weeks (drug administration is continuous).'}], 'timeFrame': '4, 8, and 12 weeks', 'description': 'Total score was not analyzed since we analyzed the sub scales. Additionally, the authors of the instrument do not recommend analyzing the total score.', 'reportingStatus': 'POSTED', 'populationDescription': 'Measure not analyzed.'}, {'type': 'SECONDARY', 'title': 'Social Responsiveness Scale (SRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-Acetyl Cysteine', 'description': 'active compound N-Acetyl Cysteine\n\nN-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\n\nEntire intervention lasts for 12 weeks (drug administration is continuous).'}, {'id': 'OG001', 'title': 'Sugar Pill', 'description': 'Placebo or sugar pill\n\nPlacebo - 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\n\nEntire intervention lasts for 12 weeks (drug administration is continuous).'}], 'classes': [{'title': 'Baseline SRS Total Score', 'categories': [{'measurements': [{'value': '111.9', 'spread': '28.3', 'groupId': 'OG000'}, {'value': '104.7', 'spread': '28.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 SRS Total Score', 'categories': [{'measurements': [{'value': '93.8', 'spread': '26.7', 'groupId': 'OG000'}, {'value': '98.5', 'spread': '37.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.141', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'F-values were derived from the interaction of Participant Group (NAC vs. Placebo) and Time (Week) in mixed effects regression models.', 'statisticalMethod': 'mixed effects regression models', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'degrees of freedom were 1, 22'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'SRS total score (range 0-195); higher scores mean more social impairment', 'unitOfMeasure': 'SRS total score (range 0-195)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We analyzed subjects who had follow-up data available.'}, {'type': 'SECONDARY', 'title': 'Sensory Profile Questionnaire (SPQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-Acetyl Cysteine', 'description': 'active compound N-Acetyl Cysteine\n\nN-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\n\nEntire intervention lasts for 12 weeks (drug administration is continuous).'}, {'id': 'OG001', 'title': 'Sugar Pill', 'description': 'Placebo or sugar pill\n\nPlacebo - 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\n\nEntire intervention lasts for 12 weeks (drug administration is continuous).'}], 'timeFrame': '12 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected. Measure not analyzed.'}, {'type': 'SECONDARY', 'title': 'Glutathione (GSH) Metabolism Intermediates in Peripheral Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-Acetyl Cysteine', 'description': 'active compound N-Acetyl Cysteine\n\nN-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\n\nEntire intervention lasts for 12 weeks (drug administration is continuous).'}, {'id': 'OG001', 'title': 'Sugar Pill', 'description': 'Placebo or sugar pill\n\nPlacebo - 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\n\nEntire intervention lasts for 12 weeks (drug administration is continuous).'}], 'timeFrame': '12 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected. The measure was not analyzed. The lab was not able to measure Glutathione for the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'N-Acetyl Cysteine', 'description': 'active compound N-Acetyl Cysteine\n\nN-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\n\nEntire intervention lasts for 12 weeks (drug administration is continuous).'}, {'id': 'FG001', 'title': 'Sugar Pill', 'description': 'Placebo or sugar pill\n\nPlacebo - 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\n\nEntire intervention lasts for 12 weeks (drug administration is continuous).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Unwilling to take the compound (taste)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': "Recruitment started in March 2009 and ended in September 2010. This study was conducted in the Autism \\& Developmental Disabilities Clinic in the Division of Child \\& Adolescent Psychiatry, Lucile Packard Children's Hospital at Stanford University.", 'preAssignmentDetails': 'Fifty-one potential subjects inquired about the study. Forty-three of the subjects signed a consent form. Seven subjects were excluded because they did not meet criteria for autistic disorder. Three subjects decided not to participate in the study before baseline measures were obtained. Thirty-three subjects were randomized in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'N-Acetyl Cysteine', 'description': 'active compound N-Acetyl Cysteine\n\nN-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\n\nEntire intervention lasts for 12 weeks (drug administration is continuous).'}, {'id': 'BG001', 'title': 'Sugar Pill', 'description': 'Placebo or sugar pill\n\nPlacebo - 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\n\nEntire intervention lasts for 12 weeks (drug administration is continuous).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-10', 'studyFirstSubmitDate': '2008-02-22', 'resultsFirstSubmitDate': '2016-08-12', 'studyFirstSubmitQcDate': '2008-02-29', 'lastUpdatePostDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-10', 'studyFirstPostDateStruct': {'date': '2008-03-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Number of Subjects With Reported Side Effects as Assessed by Dosage Record and Treatment Emergent Symptom Scale (DOTES)', 'timeFrame': '4, 8, and 12 weeks', 'description': '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.'}, {'measure': 'The Clinical Global Rating Scale (CGRS) Improvement Subscale Score', 'timeFrame': '12 weeks', 'description': 'Score range 1-7 (lower score mean more improvement compared to baseline)'}, {'measure': 'Glutathione (GSH) Levels in Peripheral Blood, Measured by State-of-the-art High-performance Liquid Chromatography (HPLC)', 'timeFrame': '12 weeks', 'description': 'Data not collected. The laboratory was not able to measure Glutathione levels.'}, {'measure': 'Irritability Subscale of the Aberrant Behavior Checklist (ABC)', 'timeFrame': 'baseline and 12 weeks', 'description': 'Aberrant Behavior Checklist (ABC) Irritability Subscale Score (range 0-45); higher scores mean higher irritability'}], 'secondaryOutcomes': [{'measure': 'The Aberrant Behavior Checklist Total Score (ABC)', 'timeFrame': '4, 8, and 12 weeks', 'description': 'Total score was not analyzed since we analyzed the sub scales. Additionally, the authors of the instrument do not recommend analyzing the total score.'}, {'measure': 'Social Responsiveness Scale (SRS)', 'timeFrame': '12 weeks', 'description': 'SRS total score (range 0-195); higher scores mean more social impairment'}, {'measure': 'Sensory Profile Questionnaire (SPQ)', 'timeFrame': '12 weeks'}, {'measure': 'Glutathione (GSH) Metabolism Intermediates in Peripheral Blood', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Autistic Disorder']}, 'referencesModule': {'references': [{'pmid': '22342106', 'type': 'RESULT', 'citation': 'Hardan AY, Fung LK, Libove RA, Obukhanych TV, Nair S, Herzenberg LA, Frazier TW, Tirouvanziam R. A randomized controlled pilot trial of oral N-acetylcysteine in children with autism. Biol Psychiatry. 2012 Jun 1;71(11):956-61. doi: 10.1016/j.biopsych.2012.01.014. Epub 2012 Feb 18.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nWe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Outpatients between 3.0 and 12.11 years of age inclusive\n2. Males and females who are physically healthy\n3. diagnosis of autism based Diagnostic and Statistical Manual (DSM-IV-TR) criteria, the Autism Diagnostic Interview-Revised, and expert clinical evaluation\n4. Clinical Global Impression Severity rating of 4\n5. Care provider who can reliably bring subject to clinic visits, can provide trustworthy ratings, and interacts with subject on a regular basis\n6. Ability of subject to swallow the compound\n7. Stable concomitant medications for at least 2 weeks\n8. No planned changes in psychosocial interventions during the open-label N-Acetyl Cysteine trial\n\nExclusion Criteria:\n\n1. DSM-IV-TR diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified\n2. Prior adequate trial of N-Acetyl Cysteine\n3. Active medical problems: unstable seizures, significant physical illness (e.g., serious liver or renal pathology)\n4. Pregnancy or sexually active females\n5. Subjects taking antioxidant agents and glutathione prodrugs will be excluded from the study except if they have been off these compounds for at least 4 weeks'}, 'identificationModule': {'nctId': 'NCT00627705', 'briefTitle': 'A Study of N-Acetyl Cysteine in Children With Autism', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Double-blind , Randomized, Placebo Controlled Study of N-Acetyl Cysteine in Autism.', 'orgStudyIdInfo': {'id': 'SU-02012008-995'}, 'secondaryIdInfos': [{'id': '10142'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'N-Acetyl Cysteine', 'description': 'active compound N-Acetyl Cysteine', 'interventionNames': ['Drug: N-Acetyl Cysteine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar pill', 'description': 'Placebo or sugar pill', 'interventionNames': ['Other: Placebo - sugar pill']}], 'interventions': [{'name': 'N-Acetyl Cysteine', 'type': 'DRUG', 'otherNames': ['NAC'], 'description': '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\n\nEntire intervention lasts for 12 weeks (drug administration is continuous).', 'armGroupLabels': ['N-Acetyl Cysteine']}, {'name': 'Placebo - sugar pill', 'type': 'OTHER', 'otherNames': ['Placebo'], 'description': '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\n\nEntire intervention lasts for 12 weeks (drug administration is continuous).', 'armGroupLabels': ['Sugar pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Antonio Hardan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Antonio Hardan', 'investigatorAffiliation': 'Stanford University'}}}}