Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00517504
Status:
COMPLETED
Last Update Posted:
2012-07-04
First Post:
2007-08-15
Brief Title:
Methylphenidate Study in Young Children With Developmental Disorders
Sponsor:
University of Arizona
Organization:
University of Arizona
Study Overview
Official Title:
Methylphenidate Study in Young Children With Developmental Disorders
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if methylphenidate a common brand name is Ritalin a medicine used for treating older children with Attention Deficit and Hyperactivity Disorder ADHD is also safe and helpful for problems related to symptoms of ADHD in young children with Developmental Disorders DD
Detailed Description:
Currently there is no systematic empirical information to guide the use of methylphenidate a common brand name is Ritalin to treat symptoms of ADHD in young children with Autistic DisorderAspergers DisorderPervasive Developmental Disorder Not Otherwise SpecifiedDevelopmental Disorders Preliminary data from a recent study of ADHD in young children suggest that methylphenidate may be useful in children with developmental disorders DD The purpose of this study is to determine the safety and efficacy of methylphenidate to treat ADHD symptoms in young children with Pervasive Developmental Disorders PDD or Developmental Disorders DD
All subjects will be screened for eligibility inclusion and exclusion criteria All concurrent non-pharmacological therapies will be stabilized for a minimum period of 2 weeks prior to the childs entry into the drug phase of the study At each medication follow-up visit a detailed history will be obtained and recorded for all concurrent treatments If a child enrolls in this study hisher participation will last approximately 3 to 4½ months with 12-18 outpatient daytime visits
Screening assessment The childs parent and teacherdaycare provider if applicable will need to complete some forms that describe the childs problems with overactivity impulsivity and inattention If these forms indicate that the child may have ADHD the investigator will schedule outpatient-screening assessments The research staff will evaluate the child to see if she has a Developmental Disorder DD or PDD and ADHD Each child will receive a developmental assessment and each parent will be interviewed about his or her childs behavior The childs teacher will be given several rating forms to complete The parents will be asked to complete some questions about the childs development Both parents if available will be interviewed about their family histories Some of the screening assessments will be videotapedaudiotaped Each child will have a physical examination an electrocardiogram EKG a urine test and a blood test The doctor will ask the parents about his or her childs medical history
Medication phase After screening assessments are completed the child will enter the medication phase of the study Each child will first have a step-wise single-blind titration of MPH to determine hisher best dose followed by a double-blind crossover trial with placebo and the childs best dose The order of active drug and placebo will be randomized across the sample so that half the children will first receive MPH for 2 weeks and the other half will first receive placebo for 2 weeks The children will receive the alternative drug condition placebo or the childs best dose for the next 2 weeks
The child and hisher parents will come back each week for a clinic visit At each visit the childs height weight blood pressure and pulse will be checked The childs parents and teacherdaycare provider if applicable will be asked to complete some rating scales every week
All subjects will be screened for eligibility inclusion and exclusion criteria All concurrent non-pharmacological therapies will be stabilized for a minimum period of 2 weeks prior to the childs entry into the drug phase of the study At each medication follow-up visit a detailed history will be obtained and recorded for all concurrent treatments If a child enrolls in this study hisher participation will last approximately 3 to 4½ months with 12-18 outpatient daytime visits
Screening assessment The childs parent and teacherdaycare provider if applicable will need to complete some forms that describe the childs problems with overactivity impulsivity and inattention If these forms indicate that the child may have ADHD the investigator will schedule outpatient-screening assessments The research staff will evaluate the child to see if she has a Developmental Disorder DD or PDD and ADHD Each child will receive a developmental assessment and each parent will be interviewed about his or her childs behavior The childs teacher will be given several rating forms to complete The parents will be asked to complete some questions about the childs development Both parents if available will be interviewed about their family histories Some of the screening assessments will be videotapedaudiotaped Each child will have a physical examination an electrocardiogram EKG a urine test and a blood test The doctor will ask the parents about his or her childs medical history
Medication phase After screening assessments are completed the child will enter the medication phase of the study Each child will first have a step-wise single-blind titration of MPH to determine hisher best dose followed by a double-blind crossover trial with placebo and the childs best dose The order of active drug and placebo will be randomized across the sample so that half the children will first receive MPH for 2 weeks and the other half will first receive placebo for 2 weeks The children will receive the alternative drug condition placebo or the childs best dose for the next 2 weeks
The child and hisher parents will come back each week for a clinic visit At each visit the childs height weight blood pressure and pulse will be checked The childs parents and teacherdaycare provider if applicable will be asked to complete some rating scales every week
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None