Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00183391
Status:
COMPLETED
Last Update Posted:
2018-06-06
First Post:
2005-09-13
Brief Title:
Stimulant Versus Nonstimulant Medication for Attention Deficit Hyperactivity Disorder in Children
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Measuring and Predicting Response to Atomoxetine and Methylphenidate
Status:
COMPLETED
Status Verified Date:
2018-05
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:
This study will determine the effectiveness of stimulant and nonstimulant medication in treating the symptoms of attention deficit hyperactivity disorder ADHD in children and adolescents
Detailed Description:
ADHD is one of the most frequently occurring disorders of children and adolescents and is a significant public health problem The most common treatment for the condition is stimulant medication However there are an increasing number of children who are experiencing negative side effects from stimulants such as dizziness loss of appetite and headaches these side effects have made the need for alternative treatments all the more important This study will compare the stimulant methylphenidate to the nonstimulant atomoxetine to determine which is more effective in treating ADHD symptoms in children and adolescents The two medications differ in the neurotransmitters they influence Stimulants such as methylphenidate act upon the neurotransmitter dopamine while atomoxetine works on norepinephrine It has been proposed that the difference in neurotransmitter stimulation may result in differences in an ADHD patients response to treatment
Participants will be randomly assigned to receive either methylphenidate or atomoxetine for between 4 to 6 weeks depending on how soon they respond to the treatment After the 4 to 6 week period participants will be crossed-over to receive whichever medication they did not receive in the first part of the study
Participants will have up to 14 weekly study visits Over the first two visits participants will undergo psychological and intelligence tests a medical history an electrocardiogram blood and urine collection and a physical exam The remaining visits will occur weekly During these visits participants will receive their assigned medication and along with their parents will complete questionnaires about their response to treatment and any side effects they may be experiencing The teachers of all participants will be asked to complete a questionnaire about their students behavior at 4 different times during the study Participant parent and teacher questionnaires will be used to assess the ADHD symptoms of participants as well as self-report clinical scales completed by the participants
Participants will be randomly assigned to receive either methylphenidate or atomoxetine for between 4 to 6 weeks depending on how soon they respond to the treatment After the 4 to 6 week period participants will be crossed-over to receive whichever medication they did not receive in the first part of the study
Participants will have up to 14 weekly study visits Over the first two visits participants will undergo psychological and intelligence tests a medical history an electrocardiogram blood and urine collection and a physical exam The remaining visits will occur weekly During these visits participants will receive their assigned medication and along with their parents will complete questionnaires about their response to treatment and any side effects they may be experiencing The teachers of all participants will be asked to complete a questionnaire about their students behavior at 4 different times during the study Participant parent and teacher questionnaires will be used to assess the ADHD symptoms of participants as well as self-report clinical scales completed by the participants
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR 84-CTM | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH070564 |
| R01MH070935 | NIH | None | None |
| R01MH070564 | NIH | None | None |