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

July 20, 2011 updated by: Peking University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
262

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 12 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Executive function test
Time Frame: seven to ten weeks
seven to ten weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
ADHD Rating Scale-IV
Time Frame: seven to ten weeks
seven to ten weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yufeng Wang, M.D. PH.D., Peking University Institute of Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CON-I-07-CN-029-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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