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

Randomized Control Study of Concerta and Strattera on the Improvement of Executive Function in Attention Deficit Hyperactivity Disorder Children

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Drug: OROS MPH; Drug: Atomoxetine

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
• Enrollment (Actual): 262
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Sixth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Strattera
No Intervention: control; the normal control with no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Executive function test	seven to ten weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
ADHD Rating Scale-IV	seven to ten weeks

Collaborators and Investigators

• Sponsor: Peking University
• Investigators: Principal Investigator: Yufeng Wang, M.D. PH.D., Peking University Institute of Mental Health

Publications and helpful links

General Publications

• Su Y, Yang L, Stein MA, Cao Q, Wang Y. Osmotic Release Oral System Methylphenidate Versus Atomoxetine for the Treatment of Attention-Deficit/Hyperactivity Disorder in Chinese Youth: 8-Week Comparative Efficacy and 1-Year Follow-Up. J Child Adolesc Psychopharmacol. 2016 May;26(4):362-71. doi: 10.1089/cap.2015.0031. Epub 2016 Jan 18.
• Yang L, Cao Q, Shuai L, Li H, Chan RC, Wang Y. Comparative study of OROS-MPH and atomoxetine on executive function improvement in ADHD: a randomized controlled trial. Int J Neuropsychopharmacol. 2012 Feb;15(1):15-26. doi: 10.1017/S1461145711001490. Epub 2011 Oct 21.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: February 8, 2010
• First Submitted That Met QC Criteria: February 8, 2010
• First Posted (Estimate): February 9, 2010

Study Record Updates

• Last Update Posted (Estimate): July 22, 2011
• Last Update Submitted That Met QC Criteria: July 20, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: attention deficit hyperactivity disorder; atomoxetine; executive function; OROS MPH
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Disease; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Adrenergic Uptake Inhibitors; Atomoxetine Hydrochloride
• Other Study ID Numbers: CON-I-07-CN-029-B