Stimulant Versus Nonstimulant Medication for Attention Deficit Hyperactivity Disorder in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00183391
First received: September 13, 2005
Last updated: April 6, 2009
Last verified: April 2009
  Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Measuring and Predicting Response to Atomoxetine and Methylphenidate

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • ADHD-Rating Scale (ADHD RS)- IV- Parent Version [ Time Frame: Measured at each visit ] [ Designated as safety issue: No ]
  • Clinical Global Impressions (CGI)- Severity, Overall, Improvement [ Time Frame: Measured weekly throughout the study ] [ Designated as safety issue: No ]
  • Conners Parent Rating Scale- Short Form [ Time Frame: Measured at screening, baselines one and two, and ends of treatments one and two ] [ Designated as safety issue: No ]
  • Atomoxetine-Stimulant Side Effects Ratings Scale [ Time Frame: Measured at each visit ] [ Designated as safety issue: Yes ]
  • Weiss Functional Impairment Scale [ Time Frame: Measured at screening, baselines one and two, and ends of treatments one and two ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Conners-Wells Adolescent Self Report [ Time Frame: Measured at screening, baselines one and two, and ends of treatments one and two ] [ Designated as safety issue: No ]
  • Conners Teacher Rating Scale- Short [ Time Frame: Measured at screening, baselines one and two, and ends of treatments one and two ] [ Designated as safety issue: No ]
  • Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version (K-SADS-PL) [ Time Frame: Measured at screening ] [ Designated as safety issue: No ]
  • Psychiatric History and Mental Status Examination [ Time Frame: Measured at screening ] [ Designated as safety issue: No ]
  • Child Behavior Checklist (CBCL) [ Time Frame: Measured at screening ] [ Designated as safety issue: No ]
  • Social Skills Rating Scale (SSRS)- Parent Version [ Time Frame: Measured at screening, baselines one and two, and ends of treatments one and two ] [ Designated as safety issue: No ]
  • Social Skills Rating Scale (SSRS)- Teacher Version [ Time Frame: Measured at screening, baselines one and two, and ends of treatments one and two ] [ Designated as safety issue: No ]
  • Child Conflict Index (CCI) [ Time Frame: Measured at screening, baselines one and two, and ends of treatments one and two ] [ Designated as safety issue: No ]
  • Wechsler Intelligence Scale for Children - 4th Edition (WISC-IV) [ Time Frame: Measured at screening ] [ Designated as safety issue: No ]
  • Wechsler Individual Achievement Test II Abbreviated (WIAT II A) [ Time Frame: Measured at screening ] [ Designated as safety issue: No ]
  • Continuous Performance Test (CPT) [ Time Frame: Measured at screening, baselines one and two, and ends of treatments one and two ] [ Designated as safety issue: No ]
  • Permanent Mathematics Product Test (PERMP) [ Time Frame: Measured at screening, baselines one and two, and ends of treatments one and two ] [ Designated as safety issue: No ]
  • Children's Sleep Questionnaire [ Time Frame: Measured at screening, baselines one and two, and ends of treatments one and two ] [ Designated as safety issue: No ]
  • Actigraphy [ Time Frame: Measured daily throughout the study ] [ Designated as safety issue: No ]
  • Sleep logs [ Time Frame: Measured daily throughout the study ] [ Designated as safety issue: No ]
  • Hyperactivity, Attention, and Learning Problems (HALP) Medical and Developmental History Questionnaire [ Time Frame: Measured at screening ] [ Designated as safety issue: No ]
  • Vital signs [ Time Frame: Measured at each visit ] [ Designated as safety issue: No ]
  • Open Ended Adverse Event Questioning [ Time Frame: Measured at each visit ] [ Designated as safety issue: Yes ]
  • Modified Yale Global Tic Severity Scale [ Time Frame: Measured at screening, baselines one and two, and ends of treatments one and two ] [ Designated as safety issue: No ]
  • Assessment of Affective Range (AAR) [ Time Frame: Measured at screening, baselines one and two, and ends of treatments one and two ] [ Designated as safety issue: No ]
  • Treatment Preference Survey [ Time Frame: Measured at ends of treatments one and two ] [ Designated as safety issue: No ]
  • HALP Rebound Effects Questionnaire [ Time Frame: Measured at ends of treatments one and two and baseline two ] [ Designated as safety issue: No ]

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
Experimental: 1
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.
Active Comparator: 2
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.

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 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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets DSM-IV-TR criteria for ADHD
  • Scores at least 1.5 standard deviation higher than age and gender mean on ADHD-RS keyed to ADHD subtype
  • CGI Severity ADHD Rating greater than or equal to 4
  • Currently attends school with at least 3 months left in high school
  • Currently lives at home with parent(s) or legal guardian(s), now and for the past year before study entry, and is expected to remain there
  • Normal physical exam, laboratory tests, and electrocardiogram
  • Pulse and blood pressure within 95% of age and gender mean
  • Full Scale IQ is greater than or equal to 75 OR if the results of testing indicate that Full Scale IQ is not a good indicator of intellectual ability, a General Ability Index greater than or equal to 75
  • Weight is between 20 and 85 kilograms
  • Able to swallow pills
  • Parent or guardian willing to provide informed consent

Exclusion Criteria:

  • History of atomoxetine or methylphenidate intolerance
  • Any existing medical condition for which study medications are contraindicated
  • If the child is in psychotherapy, no changes in therapy expected during the study trial
  • Presence of any of the following: autism, mental retardation, schizophrenia, a psychotic disorder, bipolar disorder, severe depression, or conduct disorder
  • Presence of a comorbid disorder that should be the primary focus of treatment
  • Presence of a medical or neurological disorder precluding study medications or assessing ADHD
  • Allergic reactions to multiple medications
  • History of alcohol or drug abuse in the 3 months before study entry, or positive urine toxic screen that is not explained by a time limited medical circumstance
  • Involved in a medication treatment study in the 30 days before study entry
  • Female who is sexually active and is unwilling to use birth control
  • Evidence of child abuse or neglect
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183391

Contacts
Contact: Heather A. Phillips, MA 312-996-2389 hphillips@psych.uic.edu
Contact: Lauren R. Maul, MA 312-355-3319 lmaul@psych.uic.edu

Locations
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         
Sponsors and Collaborators
Investigators
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
  More Information

No publications provided

Responsible Party: Mark Stein, PhD, The University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00183391     History of Changes
Other Study ID Numbers: R01 MH070935, R01 MH70564, DSIR 84-CTM
Study First Received: September 13, 2005
Last Updated: April 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
ADHD
Child
Adolescent
School

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Atomoxetine
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on July 20, 2014