Safety and Effectiveness of D-Cycloserine in Children With Autism
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by National Institute of Mental Health (NIMH).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Collaborators:
National Alliance for Research on Schizophrenia and Depression
Indiana University School of Medicine
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00198120
First received: September 12, 2005
Last updated: October 7, 2008
Last verified: October 2008
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Purpose
This study will determine the effectiveness of D-cycloserine in reducing symptoms of autism in autistic children.
| Condition | Intervention | Phase |
|---|---|---|
|
Autistic Disorder |
Drug: D-cycloserine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Trial of D-Cycloserine in Autism |
Resource links provided by NLM:
Further study details as provided by National Institute of Mental Health (NIMH):
Primary Outcome Measures:
- Clinical Global Impressions (CGI) Global Improvement [ Time Frame: After 8 weeks of Double-Blind Treatment and after Open-Label Treatment ] [ Designated as safety issue: No ]
- Lethargy Subscale of the Aberrant Behavior Checklist (ABC) [ Time Frame: After 8 weeks of Double-Blind treatment and after Open-Label Treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Modified Compulsive subscale of the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [ Time Frame: After 8 weeks of Double-Blind treatment and after Open-Label treatment ] [ Designated as safety issue: No ]
- Autism Diagnostic Observation Schedule (ADOS) [ Time Frame: After 8 weeks of Double-Blind treatment and after Open-Label treatment ] [ Designated as safety issue: No ]
- Vineland Maladaptive Behavior Subscales of the Vineland Adaptive Behavior Subscales [ Time Frame: After 8 weeks of Double-Blind treatment and after Open-Label treatment ] [ Designated as safety issue: No ]
- Social Reciprocity Scale (SRS) [ Time Frame: After 8 weeks of Double-Blind treatment and after Open-Label treatment ] [ Designated as safety issue: No ]
- Individualized Target Symptom Assessment [ Time Frame: After 8 weeks of Double-Blind treatment and after Open-Label treatment ] [ Designated as safety issue: No ]
- Teacher-rated Aberrant Behavior Checklist (ABC) [ Time Frame: After 8 weeks of Double-Blind treatment and after short term Open-Label treatment (8 weeks) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | February 2004 |
| Estimated Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants will receive D-Cycloserine for 8 weeks.
|
Drug: D-cycloserine
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: same dosing schedule and capsule strength
Other Names:
|
|
Placebo Comparator: 2
Participants will receive placebo for 8 weeks.
|
Drug: D-cycloserine
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: same dosing schedule and capsule strength
Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 3 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 3 Years to 12 Years
- DSM-IV and ADI-R-confirmed Diagnosis of Autistic Disorder
- Aberrant Behavior Checklist (ABC) Lethargy Subscale Score of 13 or greater
Exclusion Criteria:
- Children with Severe to Profound Mental Retardation
- Weight at Screening Visit <11 kilograms
- Clinical Global Impressions-Severity Score of 7
- Presence of a Neurodevelopmental Disorder with Possible Associations to Autism: Subjects with Fragile X Syndrome, Tuberous Sclerosis, or other neurodevelopmental disorders known to be associated with autism or autistic features will be excluded.
- Presence of a Psychiatric Disorder that would Require a Specific Type of Treatment: Subjects with major depressive disorder, bipolar disorder, or a psychotic disorder will be excluded because treatment for these disorders often requires specific psychotropic agents. Subjects with an active substance use disorder will be excluded because of safety concerns and problems this would cause in assessing efficacy.
- Presence of a Medical Condition that would make Treatment with D-Cycloserine Less Safe: Subjects with significant cardiac, hepatic, or renal disease will be excluded due to concerns about pharmacokinetic alterations or adverse effects. Subjects with epilepsy or a history of seizures will be excluded due to rare reports of seizures with high doses of D-cycloserine. D-cycloserine is an U.S. FDA Pregnancy Category C drug. Because of the unknown effects of D-cycloserine on the developing human fetus, females of childbearing potential will be given a urine pregnancy test and required to use a suitable form of birth control during the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00198120
Locations
| United States, Indiana | |
| Riley Hospital for Children, Christian Sarkine Autism Treatment Center | |
| Indianapolis, Indiana, United States, 46202 | |
Sponsors and Collaborators
National Alliance for Research on Schizophrenia and Depression
Indiana University School of Medicine
Investigators
| Principal Investigator: | David J. Posey, MD | Indiana University School of Medicine |
More Information
No publications provided
| Responsible Party: | David J. Posey, MD, MS, Indiana University School of Medicine / Department of Child Psychiatry |
| ClinicalTrials.gov Identifier: | NCT00198120 History of Changes |
| Other Study ID Numbers: | K23 MH68627, 0305-30, DDTR BK-TKND |
| Study First Received: | September 12, 2005 |
| Last Updated: | October 7, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Autistic Disorder cycloserine pharmacology glutamatergic agents |
communication social interaction Double-Blind Method |
Additional relevant MeSH terms:
|
Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders Cycloserine Excitatory Amino Acid Agents Anti-Infective Agents, Urinary Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Renal Agents Antibiotics, Antitubercular Anti-Bacterial Agents Antitubercular Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013