Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00517647
Status:
COMPLETED
Last Update Posted:
2012-07-09
First Post:
2007-08-15
Brief Title:
Atomoxetine Pilot Study in Preschool Children With ADHD
Sponsor:
University of Arizona
Organization:
University of Arizona
Study Overview
Official Title:
Atomoxetine Pilot Study in Preschool Children With ADHD
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 atomoxetine a common brand name is Strattera a medicine that is used for treating older children with Attention Deficit and Hyperactivity Disorder ADHD is also safe and helpful for ADHD problems in young children While atomoxetine is not approved by the FDA for use in children younger than 6 years the FDA has given permission to study this drug in this age group
Detailed Description:
Prevalence of Attention Deficit Hyperactivity Disorder ADHD in school age children is estimated to be 2 to 11 Many preschool age children have problems with hyperactivity short attention span impulsivity and other behavior dyscontrol and are quite likely to continue to have difficulties in elementary school years Many of these children are referred for diagnosis and management of their difficult behavior and are diagnosed with ADHD Children with ADHD often display disruptive behaviors that interfere with their functioning at school home and in the community due to symptoms of hyperactivity impulsiveness and inattention
Symptoms of ADHD may be underdiagnosed and undertreated in preschool children Preschool children with ADHD often require vigilant monitoring and supervision to ensure their safety Symptoms of impulsivity hyperactivity and distractibility often limit the effectiveness of educational and behavioral interventions Hence it is important to treat the symptoms of ADHD in children at an early age Early intervention in children with ADHD may have an impact in the course of illness by abating longer-term disability in vulnerable children
Pharmacological agents are considered a standard treatment recommendation in children with ADHD Recently a non-stimulant pharmacological agent atomoxetine ATMX has been reported to be effective and safe in school-age children with ADHD Data are not available for the usefulness of ATMX in children younger than 6 years However parents of younger children with ADHD are frequently asking practicing physicians to prescribe ATMX for their child since they do not want their child taking stimulants
There is a need to carry out treatment trials with ATMX in preschool children with ADHD in order to collect data on how effective the drug is its safety and the best doses to administer to children with ADHD Therefore this study will be a pilot project to obtain preliminary data that will then be used to help set up a larger study that will examine preschool children with ADHD
All subjects will be screened for eligibility inclusion and exclusion criteria Since other therapies including behavior therapy are routinely indicated for ethical reasons subjects will continue to receive all concurrent therapies throughout the study period All concurrent 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 7 to 13 weeks with a minimum of 7 outpatient daytime visits The visits will be weekly in the beginning and then every other week once the child is taking an optimum dose of atomoxetine Visits will take 1-5 hours each and will take place at the Department of Psychiatry in the Arizona Health Sciences Center Tucson The study consists of 2 periods
Screening assessment The screening visits isare used to determine if a child is eligible for participation The childs teacherdaycare provider with the parents permission and the parents will need to complete some forms describing the childs problems with overactivity impulsivity and inattention The screening assessments may be completed over 1-2 visits Each visit will take about 3-5 hours to complete The research staff will evaluate each child to see if she has ADHD Parents will be interviewed about their childs behavior The childs teacher will be given several rating forms to complete Parents will be asked to complete some questions about their childs development Both parents if available and will be interviewed about their family histories
After it is determined that a child is eligible to participate there will be a baseline visit The childs previous ineffective medication will be discontinued The ratings done at the first visit will be repeated including both the teacher and parent rating scales The child will have vital signs taken including height weight blood pressure and pulse rate an electrocardiogram EKG a test of heart rhythm recorded by putting sticky pads on the chest a urine test and a blood test about 10cc or 1 tablespoon The doctor will ask the parents about the childs medical history Parents will be told about any abnormal laboratory values or physical findings that may be discovered during this study This information will also be available to the childs pediatrician if the parents request this be done
Medication phase After screening assessments are completed the child will enter the medication phase of the study The child will be started on atomoxetine at 05 mgkgday with the dosage increased to a maximum dose of 18 mgkgday The dose will be determined by how well the child responds to and tolerates the drug The dose will be given twice a day to minimize side effects After the optimum dose is determined the child will be kept at this stable dose for 4 weeks
At each visit vital signs will be taken including height weight blood pressure and pulse rate Interviews play assessments checklist and questionnaires will be completed at each visit in order to assess how well the child is doing and whether there are symptoms or side effects Teachers will also continue to be asked to fill out assessments
If the childs behavior gets worse or she experiences any side effects parents should call the study doctor immediately and it will be determined if any changes in the childs treatment will need to be made Participants will be given a card with telephone numbers and important information needed to get in touch with the doctor at any time day or night
Some of the screening assessments will be videotapedaudiotaped These tapes will be used for later coding supervision of the childs doctortherapist review by offsite consultantsmentors training of other doctorstherapists andor for presentations at conferences The tapes can be erased at any time during or after the session at the parents request
Symptoms of ADHD may be underdiagnosed and undertreated in preschool children Preschool children with ADHD often require vigilant monitoring and supervision to ensure their safety Symptoms of impulsivity hyperactivity and distractibility often limit the effectiveness of educational and behavioral interventions Hence it is important to treat the symptoms of ADHD in children at an early age Early intervention in children with ADHD may have an impact in the course of illness by abating longer-term disability in vulnerable children
Pharmacological agents are considered a standard treatment recommendation in children with ADHD Recently a non-stimulant pharmacological agent atomoxetine ATMX has been reported to be effective and safe in school-age children with ADHD Data are not available for the usefulness of ATMX in children younger than 6 years However parents of younger children with ADHD are frequently asking practicing physicians to prescribe ATMX for their child since they do not want their child taking stimulants
There is a need to carry out treatment trials with ATMX in preschool children with ADHD in order to collect data on how effective the drug is its safety and the best doses to administer to children with ADHD Therefore this study will be a pilot project to obtain preliminary data that will then be used to help set up a larger study that will examine preschool children with ADHD
All subjects will be screened for eligibility inclusion and exclusion criteria Since other therapies including behavior therapy are routinely indicated for ethical reasons subjects will continue to receive all concurrent therapies throughout the study period All concurrent 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 7 to 13 weeks with a minimum of 7 outpatient daytime visits The visits will be weekly in the beginning and then every other week once the child is taking an optimum dose of atomoxetine Visits will take 1-5 hours each and will take place at the Department of Psychiatry in the Arizona Health Sciences Center Tucson The study consists of 2 periods
Screening assessment The screening visits isare used to determine if a child is eligible for participation The childs teacherdaycare provider with the parents permission and the parents will need to complete some forms describing the childs problems with overactivity impulsivity and inattention The screening assessments may be completed over 1-2 visits Each visit will take about 3-5 hours to complete The research staff will evaluate each child to see if she has ADHD Parents will be interviewed about their childs behavior The childs teacher will be given several rating forms to complete Parents will be asked to complete some questions about their childs development Both parents if available and will be interviewed about their family histories
After it is determined that a child is eligible to participate there will be a baseline visit The childs previous ineffective medication will be discontinued The ratings done at the first visit will be repeated including both the teacher and parent rating scales The child will have vital signs taken including height weight blood pressure and pulse rate an electrocardiogram EKG a test of heart rhythm recorded by putting sticky pads on the chest a urine test and a blood test about 10cc or 1 tablespoon The doctor will ask the parents about the childs medical history Parents will be told about any abnormal laboratory values or physical findings that may be discovered during this study This information will also be available to the childs pediatrician if the parents request this be done
Medication phase After screening assessments are completed the child will enter the medication phase of the study The child will be started on atomoxetine at 05 mgkgday with the dosage increased to a maximum dose of 18 mgkgday The dose will be determined by how well the child responds to and tolerates the drug The dose will be given twice a day to minimize side effects After the optimum dose is determined the child will be kept at this stable dose for 4 weeks
At each visit vital signs will be taken including height weight blood pressure and pulse rate Interviews play assessments checklist and questionnaires will be completed at each visit in order to assess how well the child is doing and whether there are symptoms or side effects Teachers will also continue to be asked to fill out assessments
If the childs behavior gets worse or she experiences any side effects parents should call the study doctor immediately and it will be determined if any changes in the childs treatment will need to be made Participants will be given a card with telephone numbers and important information needed to get in touch with the doctor at any time day or night
Some of the screening assessments will be videotapedaudiotaped These tapes will be used for later coding supervision of the childs doctortherapist review by offsite consultantsmentors training of other doctorstherapists andor for presentations at conferences The tapes can be erased at any time during or after the session at the parents request
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