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

This study has been completed.
Sponsor:
Information provided by:
Peking University
ClinicalTrials.gov Identifier:
NCT01065259
First received: February 8, 2010
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: OROS MPH
Drug: Atomoxetine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • Executive function test [ Time Frame: seven to ten weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ADHD Rating Scale-IV [ Time Frame: seven to ten weeks ] [ Designated as safety issue: No ]

Enrollment: 262
Study Start Date: April 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OROS MPH
the group treated by OROS MPH
Drug: 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

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).

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT01065259

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

No publications provided by Peking University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yufeng Wang, Peking University the Sixth Hospital
ClinicalTrials.gov Identifier: NCT01065259     History of Changes
Other Study ID Numbers: CON-I-07-CN-029-B
Study First Received: February 8, 2010
Last Updated: July 20, 2011
Health Authority: China: Ethics Committee

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

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