Concerta and Strattera on the Executive Function in Attention Deficit Hyperactivity Disorder (ADHD) Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01065259
Recruitment Status : Completed
First Posted : February 9, 2010
Last Update Posted : July 22, 2011
Information provided by:
Peking University

Brief Summary:
The objective of this study is to compare the effect of Concerta (Osmotic Release Oral System Extended Release Methylphenidate HCL, OROS MPH) and Strattera (Atomoxetine) on the laboratory and ecological executive function in children with attention deficit hyperactivity disorder.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: OROS MPH Drug: Atomoxetine Phase 4

Detailed Description:
The sample will include 134 ADHD children and adolescence, randomized assigned to Concerta and strattera treatment group, with 67 cases in each. It will also include 67 sex and age matched normal control. The drug will be titrated to optimal dose. The executive function including inhibition, working memory, set shifting and plan will be compared among two medication group and the control group, using laboratory executive function test and Behavior Rating Inventory of Executive Function (BRIEF).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Control Study of Concerta and Strattera on the Improvement of Executive Function in Attention Deficit Hyperactivity Disorder Children
Study Start Date : April 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
Experimental: OROS MPH
the group treated by OROS MPH
The dosage began with 18mg Qd. It can be increased with 18mg every week until an optimal response achieved. The maximum dosage was no more than 54mg/d. The optimal dosage will maintain for 4 to 6 weeks
Other Name: Concerta

Active Comparator: atomoxetine
the group treated by atomoxetine
Drug: Atomoxetine
The dosage begins with 0.5mg/kg.d. It can increased to 0.8mg/kg.d at the second week, 1.2mg/kg.d at the third week, and 1.4mg/kg.d at the 5th week according to the patients response. The optimal dosage will maintain for 4 to 6 weeks.
Other Name: Strattera

No Intervention: control
the normal control with no intervention

Primary Outcome Measures :
  1. Executive function test [ Time Frame: seven to ten weeks ]

Secondary Outcome Measures :
  1. ADHD Rating Scale-IV [ Time Frame: seven to ten weeks ]

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age between 6 to 16 years old. Body weight between 20 to 60 kg
  • Meet ADHD criteria in tne Diagnostic and Statistic Manual of Mental Disorders, fourth edition (DSM-IV) through questionaire and interview
  • Intelligence quotient (IQ) >= 70
  • Currently unmedicated or effectively medicated with immediately released methylphenidate (The maximum dosage no more than 60mg/d)
  • The patient and the parent express their will to comply with the follow up including the clinical interview and all the test
  • The parent or the guardian sign the written consent
  • Can swallow the capsule

Exclusion Criteria:

  • Have administered immediate release methylphenidate, OROS MPH or atomoxetine, but ADHD symptoms not improved.
  • Bipolar I or II disorder, psychosis, or pervasive developmental disorder.
  • Meet the DSM-IV anxiety disorder.
  • Any seizure disorder (except for febrile convulsion) or electroencephalogram (EEG) abnormal associated with epilepsy, or currently taking anti-convulsion drugs.
  • Depression disorder, tend to commit suicide, or comorbid depression symptoms which need immediate treatment.
  • Tics disorder, or Tourette's syndrom(DSM-IV 307.23), or family history of tics disorder.
  • Narrow-angle glaucoma
  • cardiovascular diseases, or any diseases may be deteriorated when the pulse or the blood pressure increased, including hypertension or those taking anti-hypertension drugs.
  • Diseases significantly enhance the sympathetic nervous system activity, or taking sympathomimetic drug every day.
  • Allergic to methylphenidate or atomoxetine, or serious allergic reaction to more than one drugs or adverse event to multiple drugs before.
  • Serious gastrointestinal stenosis
  • History of alcohol, drug or other substance abuse
  • Those using unprescribed potential abuse drugs in screening.
  • In the process of the trial, the patient need to take other psychotropic drug other than the experimental drugs, including health food with central nervous system (CNS) activity (e.g. melatonin).
  • Might begin any structure psychological therapy addressed for ADHD in the process of the trial
  • Have used other psychotropic drugs in the past 30 days, including monoamine oxidase inhibitor.
  • Are participating other clinical trial.
  • Have difficulty in following up in 8 weeks.
  • Relatives of the investigator.
  • Employee of Xi-an Jensen or Eli lilly company.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01065259

China, Beijing
Peking University Sixth Hospital
Beijing, Beijing, China, 100191
Sponsors and Collaborators
Peking University
Principal Investigator: Yufeng Wang, M.D. PH.D. Peking University Institute of Mental Health

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Yufeng Wang, Peking University the Sixth Hospital Identifier: NCT01065259     History of Changes
Other Study ID Numbers: CON-I-07-CN-029-B
First Posted: February 9, 2010    Key Record Dates
Last Update Posted: July 22, 2011
Last Verified: July 2011

Keywords provided by Peking University:
attention deficit hyperactivity disorder
executive function

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Nervous System Diseases
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Central Nervous System Stimulants
Dopamine Uptake Inhibitors
Dopamine Agents