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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
OROS MPH
Atomoxetine
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring attention deficit hyperactivity disorder, executive function, OROS MPH, atomoxetine

Eligibility Criteria

6 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Peking University Sixth Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

OROS MPH

atomoxetine

control

Arm Description

the group treated by OROS MPH

the group treated by atomoxetine

the normal control with no intervention

Outcomes

Primary Outcome Measures

Executive function test

Secondary Outcome Measures

ADHD Rating Scale-IV

Full Information

First Posted
February 8, 2010
Last Updated
July 20, 2011
Sponsor
Peking University
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1. Study Identification

Unique Protocol Identification Number
NCT01065259
Brief Title
Concerta and Strattera on the Executive Function in Attention Deficit Hyperactivity Disorder (ADHD) Children
Official Title
Randomized Control Study of Concerta and Strattera on the Improvement of Executive Function in Attention Deficit Hyperactivity Disorder Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Peking University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
attention deficit hyperactivity disorder, executive function, OROS MPH, atomoxetine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
262 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OROS MPH
Arm Type
Experimental
Arm Description
the group treated by OROS MPH
Arm Title
atomoxetine
Arm Type
Active Comparator
Arm Description
the group treated by atomoxetine
Arm Title
control
Arm Type
No Intervention
Arm Description
the normal control with no intervention
Intervention Type
Drug
Intervention Name(s)
OROS MPH
Other Intervention Name(s)
Concerta
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Atomoxetine
Other Intervention Name(s)
Strattera
Intervention Description
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.
Primary Outcome Measure Information:
Title
Executive function test
Time Frame
seven to ten weeks
Secondary Outcome Measure Information:
Title
ADHD Rating Scale-IV
Time Frame
seven to ten weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yufeng Wang, M.D. PH.D.
Organizational Affiliation
Peking University Institute of Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Sixth Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
26779845
Citation
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.
Results Reference
derived
PubMed Identifier
22017969
Citation
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.
Results Reference
derived

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

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