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Safety and Effectiveness of D-Cycloserine in Children With Autism

NCT00198120 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-04-12

No results posted yet for this study

Summary

This study will determine the effectiveness of D-cycloserine in reducing symptoms of autism in autistic children.

Conditions

  • Autistic Disorder

Interventions

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

DRUG

Placebo

Placebo: same dosing schedule and capsule strength

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • National Alliance for Research on Schizophrenia and Depression

    collaborator OTHER

  • Indiana University School of Medicine

    collaborator OTHER

  • Indiana University

    lead OTHER

Principal Investigators

  • Christopher J. McDougle, MD · Indiana University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2007-09-30
Completion
2010-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00198120 on ClinicalTrials.gov