A Study of Risperdal (risperidone) in the Treatment of Children and Adolescents with Autistic Disorder
Please refer to this study by identifier NYSPI-IRB#: 5727
Principal Investigator(s)
Laurence Greenhill
Purpose
This research study will test a medicine called Risperdal (also known as risperidone) for the treatment of children and adolescents, ages 5 to 17, with symptoms of autism. This treatment can reduce irritability, aggression towards self and others, temper tantrums, and quickly changing moods. Risperdal is an FDA-approved medicine to treat these symptoms for children and adolescents with autism in this age group at 1mg per day. The purpose of this study is to find out if lower doses of Risperdal can also reduce these symptoms.
Type of Study: Clinical Trial
Setting of Study: outpatient
Clinical Trials.gov number: NCT00576732
Providing Clinical Treatment?: Yes
No Cost Treatment?: Yes
Care is provided in languages: English
Study Activities
Filling Out Forms
Blood Samples
Eligibility
Ages Eligible for Study: 5 Years - 17 Years
Genders Eligible for Study: Both
This study is not recruiting Healthy Volunteers.
Criteria
Inclusion Criteria:
1. Children must be in good physical health and weigh at least 20 kg (44 pounds)
2. Children must have a diagnosis of autistic disorder
3. Children must have an IQ of greater than 50.
4. Children having seizure disorder must be seizure-free for at least 6 consecutive months
5. Parents must agree to stop any medicines their child is taking that are not allowed in the study
6. Children who may benefit from study participation
Location: New York State Psychiatric Institute
1051 Riverside Drive, Unit 74
New York, NY 10032
Clinic: Child and Adolescent Clinic
Division: Child Psychiatry
Study chairs or principal investigators:
Laurence L. Greenhill M.D., Principal Investigator
Co-investigators:
Agnes Whitaker, M.D.,
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