Safety and Effectiveness of D-Cycloserine in Children With Autism
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|ClinicalTrials.gov Identifier: NCT00198120|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Autistic Disorder||Drug: D-cycloserine Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Controlled Trial of D-Cycloserine in Autism|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||August 2010|
Participants will receive D-Cycloserine for 8 weeks.
D-Cycloserine 0.6mg/kg/day in week 1 D-Cycloserine 1.1mg/kg/day in week 2 D-Cycloserine 1.7mg/kg/day in week 3-8 Flexible dosing based on response. Capsule Strength: 10mg, 20mg
Placebo Comparator: 2
Participants will receive placebo for 8 weeks.
Placebo: same dosing schedule and capsule strength
- Change in Clinical Global Impressions (CGI) Global Improvement [ Time Frame: Change from Baseline at 8 Weeks ]All randomized subjects in the Double-Blind Phase will be assessed for change.
- Change in Clinical Global Impressions (CGI) Global Improvement [ Time Frame: Change from Open-Label Baseline at 8 Weeks ]All placebo non-responders will enter into an open-label phase after the Double-Blind Phase
- Change in Lethargy Subscale of the Aberrant Behavior Checklist (ABC) [ Time Frame: Change from Baseline at 8 Weeks. ]All randomized subjects in the Double-Blind Phase will be assessed for change.
- Change in Lethargy Subscale of the Aberrant Behavior Checklist (ABC) [ Time Frame: Change from Open-Label Baseline at 8 Weeks ]All placebo non-responders will enter into an open-label phase after the Double-Blind Phase
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198120
|United States, Indiana|
|Riley Hospital for Children, Christian Sarkine Autism Treatment Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Christopher J. McDougle, MD||Indiana University School of Medicine|