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Comparing the Effectiveness of New Versus Older Treatments for Attention Deficit Hyperactivity Disorder (The NOTA Study)
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), July 2009
First Received: April 27, 2009   Last Updated: July 22, 2009   History of Changes
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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Dichotomized Clinical Global Impression-Effectiveness (CGI-E) scale [ Time Frame: Measured at each participant's last visit, which can occur at or before Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impressions-Improvement (CGI-I) scale [ Time Frame: Measured at each participant's last visit, which can occur at or before Week 6 ] [ Designated as safety issue: No ]
  • Clinical Global Improvements-Acceptability (CGI-A) scale [ Time Frame: Measured at each participant's last visit, which can occur at or before Week 6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: April 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Participants will receive methylphenidate transdermal system.
Drug: Methylphenidate transdermal system
Not specified in protocol; determined by local standard of care.
2: Active Comparator
Participants will receive lisdexamfetamine dimesylate.
Drug: Lisdexamfetamine dimesylate
Not specified in protocol; determined by local standard of care.
3: Active Comparator
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.
4: Active Comparator
Participants will receive mixed amphetamine salts extended release.
Drug: Mixed amphetamine salts extended release
Not specified in protocol; determined by local standard of care.

Detailed Description:

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
Criteria

Inclusion Criteria:

  • Meets DSM-IV diagnostic criteria for ADHD combined, hyperactive/impulsive, or inattentive subtype
  • Outpatient at study entry
  • Speaks English
  • Willing to be randomly assigned to one of the study treatment options as outlined in the protocol
  • No known significant history of cardiovascular disorders, including pre-existing congenital heart disease, structural heart disease, known clinically significant electrocardiogram (ECG) abnormality, or other clinically significant cardiac disorder
  • Willing to initiate study medication for ADHD within 7 days of the study baseline visit
  • May be receiving stable treatment with other drug for a comorbid disorder, defined as no changes in dose or form of drug treatment for at least 2 weeks prior to the study enrollment visit
  • May be receiving psychosocial interventions for ADHD or a comorbid disorder, defined as no changes in form of psychosocial treatment for at least 4 weeks prior to the study enrollment visit

Exclusion Criteria:

  • Hypersensitivity to study medication
  • Inpatient status at study entry
  • Currently taking another medication for ADHD, including another psychostimulant, atomoxetine, or bupropion
  • Receiving treatment with a tricyclic antidepressant at study enrollment, with the exception of low-dose imipramine for enuresis or amitriptyline for chronic pain
  • Received treatment with a monoamine oxidase inhibitor (MAOI) within the past 30 days
  • Psychostimulant drug dependence, bipolar disorder, or schizophrenia
  • Presence of psychosis
  • Severe mental retardation
  • Autism or Asperger's syndrome
  • Active suicidal ideation
  • Unable or unwilling to comply with the protocol
  • Demonstrates a lack of benefit from, an intolerance to, or contraindication to psychostimulant medicine
  • Presence of other clinically significant medical conditions, including hyperthyroidism, epilepsy or other seizure disorder, any condition for which an increase in blood pressure or heart rate would be problematic, glaucoma or other significant eye disease for which a psychostimulant would be problematic, or pre-existing gastrointestinal obstruction with gastrointestinal narrowing
  • Pregnant or positive result of pregnancy test
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889915

Contacts
Contact: Jerry Kirchner, BS CCRP 919-668-7818 jerry.kirchner@duke.edu
Contact: Alice Petersen, RN MSN CCRA 919-668-8091 alice.petersen@duke.edu

Locations
United States, North Carolina
Child and Adolescent Psychiatry Trials Network (CAPTN) Recruiting
Durham, North Carolina, United States, 27710
Contact: Jerry Kirchner, BS CCRP     919-668-7818     jerry.kirchner@duke.edu    
Contact: Alice Petersen, RN MSN CCRA     919-668-8091     alice.petersen@duke.edu    
Sponsors and Collaborators
Investigators
Principal Investigator: John S. March, MD, MPH Duke University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Duke University Medical Center ( John S. March, MD, MPH )
Study ID Numbers: P30 MH066386-02, DSIR CTM 4571; Pro00014075
Study First Received: April 27, 2009
Last Updated: July 22, 2009
ClinicalTrials.gov Identifier: NCT00889915     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
ADHD
Methylphenidate
Amphetamine

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

ClinicalTrials.gov processed this record on November 05, 2009