Autistic Disorder Clinical Trial
Official title:
A Randomized Controlled Trial of D-Cycloserine in Autism
This study will determine the effectiveness of D-cycloserine in reducing symptoms of autism in autistic children.
This project proposes to study the efficacy and safety of D-cycloserine in children with
autism. The central hypothesis of this project is that D-cycloserine will be efficacious in
reducing certain symptoms of autism including some aspects of social impairment.
Autism is a severe neuropsychiatric disorder with a prevalence of at least 0.1 %. Despite
investigations into the pharmacologic treatment of autism, no drugs have been shown to
consistently improve the core symptoms of the disorder, namely social and communication
impairment. Pilot data has suggested that D-cycloserine, a drug that affects the
N-methyl-D-aspartate (NMDA) subtype of glutamate receptor, has efficacy for the symptom of
social withdrawal in autism. In this study, children with autism will be randomly assigned
to treatment with either D-cycloserine or placebo for 8 weeks. Both the subjects and
investigators will be blind to treatment assignment. Subjects will be rated on a variety of
clinical measures to examine the effects of D-cycloserine on social withdrawal and other
symptoms of autism. Safety data including side-effects, vital signs, blood tests, and
electrocardiograms will be performed at the beginning and end of the study. This study will
provide important information about the effects of D-cycloserine for treating core and
associated symptoms of autism. It will also greatly expand the knowledge about glutamatergic
agents in autism and provide crucial information regarding the pathophysiology and future
design of drug studies in autism.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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