Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute of Mental Health (NIMH) |
---|---|
Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00183391 |
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.
Condition | Intervention | Phase |
---|---|---|
Attention Deficit Disorder With Hyperactivity |
Drug: Atomoxetine Drug: Methylphenidate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Measuring and Predicting Response to Atomoxetine and Methylphenidate |
Estimated Enrollment: | 160 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Participants will receive treatment for ADHD with the non-stimulant atomoxetine
|
Drug: Atomoxetine
Participants will be randomly assigned to receive either methylphenidate or atomoxetine for either 2 or 5 weeks, depending on how soon they respond to the treatment. After the 2- or 5-week period, participants will be crossed-over to receive whichever medication they did not receive in the first part of the study.
Drug: Methylphenidate
Participants will be randomly assigned to receive either methylphenidate or atomoxetine for either 2 or 5 weeks, depending on how soon they respond to the treatment. After the 2- or 5-week period, participants will be crossed-over to receive whichever medication they did not receive in the first part of the study.
|
2: Active Comparator
Participants will receive treatment for ADHD with the stimulant methylphenidate
|
Drug: Atomoxetine
Participants will be randomly assigned to receive either methylphenidate or atomoxetine for either 2 or 5 weeks, depending on how soon they respond to the treatment. After the 2- or 5-week period, participants will be crossed-over to receive whichever medication they did not receive in the first part of the study.
Drug: Methylphenidate
Participants will be randomly assigned to receive either methylphenidate or atomoxetine for either 2 or 5 weeks, depending on how soon they respond to the treatment. After the 2- or 5-week period, participants will be crossed-over to receive whichever medication they did not receive in the first part of the study.
|
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 patient's response to treatment.
Participants will be randomly assigned to receive either methylphenidate or atomoxetine for either 2 or 5 weeks, depending on how soon they respond to the treatment. After the 2-or 5-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 20 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 student's 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.
Ages Eligible for Study: | 6 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Heather A. Phillips, MA | 312-996-2389 | hphillips@psych.uic.edu |
Contact: Lauren R. Maul, MA | 312-355-3319 | lmaul@psych.uic.edu |
United States, Illinois | |
University of Illinois, Chicago - Institute for Juvenile Research | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Heather Phillips 312-996-2389 | |
Contact: Abby Droz, BA 847-412-0094 | |
Principal Investigator: Mark A. Stein, PhD | |
United States, New York | |
Mount Sinai School of Medicine | Recruiting |
New York City, New York, United States, 10029 | |
Contact: Erika Greisenegger 212-659-8833 Erika.greisenegger@mssm.edu | |
Contact: Jennifer Davidow, BS 212-659-8833 jennifer.davidow@mssm.edu | |
Principal Investigator: Jeffrey H. Newcorn, MD |
Principal Investigator: | Jeffrey H. Newcorn, MD | Mount Sinai School of Medicine |
Principal Investigator: | Mark A. Stein, PhD | University of Illinois, Chicago - Institute for Juvenile Research |
Principal Investigator: | Elizabeth Charney, MD | The Institute for Juvenile Research, The University of Illinois at Chicago |
Principal Investigator: | Edwin Cook, MD | The Institute for Juvenile Research, The University of Illinois at Chicago |
Responsible Party: | The University of Illinois at Chicago ( Mark Stein, PhD ) |
Study ID Numbers: | R01 MH70935, R01 MH70564, DSIR 84-CTM |
Study First Received: | September 13, 2005 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00183391 |
Health Authority: | United States: Federal Government |
ADHD Child Adolescent School |
Signs and Symptoms Dopamine Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood Atomoxetine |
Methylphenidate Neurologic Manifestations Attention Deficit and Disruptive Behavior Disorders Hyperkinesis Dyskinesias |
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Disease Adrenergic Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Nervous System Diseases |
Physiological Effects of Drugs Central Nervous System Stimulants Pharmacologic Actions Pathologic Processes Therapeutic Uses Dopamine Agents Central Nervous System Agents |