Antonio Hardan
An Open-Label Study of N-Acetyl Cysteine in Children with Autism
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: N-Acetyl Cysteine
Phase:
Phase 2Eligibility
Ages Eligible for Study:
3 years to 12 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
Subjects will be eligible for this study if they participated in the Double-blind, randomized, placebo controlled study of N-Acetyl Cysteine in Autism study at Stanford University and meet all of the following criteria:
(a) Outpatients between 3.0 and 12.11
years of age inclusive
(b) Males and females who are
physically healthy
(c) diagnosis of autism based DSM-IV-
TR criteria, the Autism Diagnostic
Interview-Revised, and expert clinical
evaluation
(d) CGI Severity rating of 4
(e) Care provider who can reliably bring
subject to clinic visits, can provide
trustworthy ratings, and interacts with
subject on a regular basis
(f) Ability of subject to swallow the
compound
(g) Stable concomitant medications for
at least 2 weeks
(h) No planned changes in psychosocial
interventions during the open-label NAC
trial
Key Exclusion Criteria:
(a) DSM-IV-TR diagnosis of
schizophrenia, schizoaffective disorder,
or psychotic disorder NOS
(b) Active medical problems: unstable
seizures, significant physical illness
(e.g., serious liver or renal pathology)
(c) Pregnancy or sexually active females
(d) Subjects taking antioxidant agents
and GSH prodrugs will be excluded from
the study except if they have been off
these compounds for at least 4 weeks
Additional Study Details
Official Title:
An Open-Label Study of N-Acetyl Cysteine in AutismAnticipated start date:
6/18/2008Lead Sponsor:
Stanford UniversityInvestigator(s):
- Antonio Hardan
- Rabin Tirouvanziam PhD
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- Dosage Record and Treatment Emergent Symptom Scale (DOTES)
- The Clinical Global Rating Scale (CGRS) Improvement subscale
- GSH levels in peripheral blood, measured by state-of-the-art high-performance liquid chromatography (HPLC)
- The Aberrant Behavior Checklist total score (ABC)
Secondary Outcomes:
- Social Responsiveness Scale (SRS)
- Sensory Profile Questionnaire (SPQ)
- The Irritability subscale of the ABC
- Yale-Brown Obsessive Compulsive scale (Y-BOCS)
- GSH metabolism intermediates in peripheral blood measured by HPLC
Total Number to be Enrolled:
40Total Number to be Enrolled at Stanford:
40More Information
Secondary ID(s):
- SU eProtocol: 12181
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
3/17/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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