A Study of N-Acetyl Cysteine in Children With Autism
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Intervention: N-Acetyl Cysteine; Placebo - sugar pill
Intervention 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
Entire intervention lasts for 12 weeks (drug administration is continuous).; 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).
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 43.0
Sex: All
Minimum age: 3 Years
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Outpatients between 3.0 and 12.11 years of age inclusive

          2. Males and females who are physically healthy

          3. diagnosis of autism based Diagnostic and Statistical Manual (DSM-IV-TR) criteria, the
             Autism Diagnostic Interview-Revised, and expert clinical evaluation

          4. Clinical Global Impression Severity rating of 4

          5. Care provider who can reliably bring subject to clinic visits, can provide trustworthy
             ratings, and interacts with subject on a regular basis

          6. Ability of subject to swallow the compound

          7. Stable concomitant medications for at least 2 weeks

          8. No planned changes in psychosocial interventions during the open-label N-Acetyl
             Cysteine trial

        Exclusion Criteria:

          1. DSM-IV-TR diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder
             not otherwise specified

          2. Prior adequate trial of N-Acetyl Cysteine

          3. Active medical problems: unstable seizures, significant physical illness (e.g.,
             serious liver or renal pathology)

          4. Pregnancy or sexually active females

          5. 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