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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00889915 |
Purpose
This study will determine whether two new psychostimulant medications are more effective, tolerable, and acceptable than two older medications for treating attention deficit hyperactivity disorder.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Disorder With Hyperactivity |
Drug: Methylphenidate transdermal system Drug: Lisdexamfetamine dimesylate Drug: Osmotic-release oral system methylphenidate (OROS MPH) Drug: Mixed amphetamine salts extended release |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Trial of Methylphenidate Transdermal System (Daytrana), Lisdexamfetamine Dimesylate (Vyvanse), OROS MPH (Concerta), and Mixed Amphetamine Salts Extended Release (Adderall XR) in Children and Adolescents With ADHD |
| Enrollment: | 228 |
| Study Start Date: | April 2009 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Participants will receive methylphenidate transdermal system.
|
Drug: Methylphenidate transdermal system
Not specified in protocol; determined by local standard of care.
Other Name: Daytrana
|
|
Active Comparator: 2
Participants will receive lisdexamfetamine dimesylate.
|
Drug: Lisdexamfetamine dimesylate
Not specified in protocol; determined by local standard of care.
Other Name: Vyvanse
|
|
Active Comparator: 3
Participants will receive osmotic-release oral system methylphenidate (OROS MPH).
|
Drug: Osmotic-release oral system methylphenidate (OROS MPH)
Not specified in protocol; determined by local standard of care.
Other Name: Concerta
|
|
Active Comparator: 4
Participants will receive mixed amphetamine salts extended release.
|
Drug: Mixed amphetamine salts extended release
Not specified in protocol; determined by local standard of care.
Other Name: Adderall XR
|
Attention deficit hyperactivity disorder (ADHD) is characterized by impulsiveness, hyperactivity, and inattention. It is seen primarily in children and adolescents and is often treated with psychostimulant medications. Osmotic-release oral system (OROS) methylphenidate, brand name Concerta, and mixed amphetamine salts extended release, brand name Adderall XR, are psychostimulant medications that have shown both efficacy (that they can have therapeutic benefits) and effectiveness (that they typically have therapeutic benefits in practice). Two newer psychostimulant medications—lisdexamfetamine dimesylate, brand name Vyvanse, and methylphenidate transdermal system, brand name Daytrana—have shown efficacy but have not been tested for effectiveness, nor have they been tested head-to-head against the older psychostimulants. This study will test the effectiveness, tolerability (lack of side effects), and acceptability (ease of use for patients) of the two newer psychostimulant medications and compare them to each other and to the two older psychostimulants.
Participation in this study will last 6 weeks, although some treatments may continue past the end of the study. At enrollment, participants will undergo a series of baseline evaluations. These will include interviews and assessments of ADHD symptoms, concurrent psychiatric disorders, medical and psychiatric history, family history of mental illness, risk and protective factors, other treatments, treatment expectancy of both the youth and parent, and vital signs. In consultation with their doctors, participants will be allowed to exclude zero, one, or two of the study medications; if they choose to exclude both of the new ADHD medications, they will not able to participate in the study. Participants will then be randomly assigned to one of the treatments they choose to include. They will receive a prescription for the medication and instructions for how to use it from their doctors; the study protocol does not specify a particular treatment regimen. Participants will undergo a second set of evaluations after 6 weeks of treatment or before, if the treatment ends earlier. This will include interviews and assessments similar to those administered at baseline as well as evaluation of any medication side effects.
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, North Carolina | |
| Child and Adolescent Psychiatry Trials Network (CAPTN) | |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: | John S. March, MD, MPH | Duke University School of Medicine |
More Information
| Responsible Party: | John S. March, MD, MPH, Duke University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00889915 History of Changes |
| Other Study ID Numbers: | P30 MH066386-02, DSIR CTM 4571; Pro00014075 |
| Study First Received: | April 27, 2009 |
| Last Updated: | February 5, 2010 |
| Health Authority: | United States: Federal Government |
|
ADHD Methylphenidate Amphetamine |
|
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 Amphetamine Methamphetamine Methylphenidate Adderall Dextroamphetamine Central Nervous System Stimulants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors |