Efficacy Of N-Acetyl Cysteine In Autism: A Double-Blind, Placebo-Controlled Randomised Trial

Phase 2

Completed

• Conditions: Autism; Mental Health - Autistic spectrum disorders

• Registration Number: ACTRN12610000635066
• Lead Sponsor: niversity of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Meet Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Autistic Disorder. If on pharmacological therapies, participants must be on stable therapy for 2 weeks prior to commencing the trial

Exclusion Criteria

Individuals with a primary diagnosis of Asperger’s Disorder, or other Pervasive Developmental Disorders. Children with a known or suspected clinically relevant systemic medical disorder. Children who have had a prior sensitivity or allergy to N-acetyl cysteine (NAC) or gluten (corn starch). Inability to comply with the treatment protocol, for example fussy restricted diet that may lead to refusal to take NAC. Parental non-fluency in English. History of epilepsy. Clinically relevant biochemical or haematological abnormalities at baseline.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in social skills (e.g. social awareness, capacity for reciprocal social communication) as measured by the Social Responsiveness Scale[Baseline, 1, 3, 6, 12 and 18 months.];Improvement in verbal and non-verbal communication, as measured by the Children's Communication Checklist[Baseline, 1, 3, 6, 12 and 18 months.];Improvement in repetitive and stereotypic behaviour as measured by the Repetitive Behavior Scale[Baseline, 1, 3, 6, 12 and 18 months.]

Secondary Outcome Measures

Name	Time	Method
Improvement in behavioural and emotional problems as measured by the Developmental Behaviour Checklist (Parent and Teacher Versions)[Baseline, 1, 3, 6, 12 and 18 months.];Improvement in everyday functioning, as measured by the Vineland Adaptive Behaviour Scales[Baseline, 6, 12 and 18 months.];Improvement in overall functioning, as assessed by the clinician using the Clinical Global Impression-Severity and Improvement (CGI-S and CGI-I)[Baseline, 1, 3, 6, 12 and 18 months.];Improvement in cognitive functioning as measured by the Wechsler Pre-School Scales of Intelligence or Wechsler Intelligence Scales for Children - 4th Edition or Psychoeducational Profile[Baseline, 6, 12 and 18 months.];Improvement in communication skills and social functioning, as measured by the Social Communication Questionnaire[Baseline, 1, 3, 6, 12 and 18 months.]