Attention Deficit Hyperactivity DisorderPhase 4NCT01065259
Concerta and Strattera on the Executive Function in Attention Deficit Hyperactivity Disorder (ADHD) Children
A Phase 4 study testing OROS MPH and Atomoxetine in people with Attention Deficit Hyperactivity Disorder, run by Peking University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- OROS MPH and Atomoxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteChina
- Study dates
- Apr 2008to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Sixth Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: 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.
Read the 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).
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- OROS MPH, Atomoxetine
- Keywords
- attention deficit hyperactivity disorder, executive function, OROS MPH, atomoxetine
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OROS MPHDrug
Also called Concerta
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
AtomoxetineDrug
Also called Strattera
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.
| Study group | Role | What they receive |
|---|---|---|
| OROS MPH | Experimental | the group treated by OROS MPH Receives: Drug: OROS MPH |
| atomoxetine | Active comparator | the group treated by atomoxetine Receives: Drug: Atomoxetine |
| control | No intervention | the normal control with no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive function test
Measured: seven to ten weeks
Secondary outcomes (1)
ADHD Rating Scale-IV
Measured: seven to ten weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startApr 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Investigators
- Yufeng Wang, M.D. PH.D., Principal investigator, Peking University Institute of Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065259
- Sponsor's protocol ID
- CON-I-07-CN-029-B
- Status last verified
- Jul 2011
- First submitted
- 8 Feb 2010
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 26779845Yang 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.
PubMed 22017969
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Study of Concerta and Strattera on the Improvement of Executive Function in Attention Deficit Hyperactivity Disorder Children
- ClinicalTrials.gov ID
- NCT01065259
- Acronym / sponsor ID
- CON-I-07-CN-029-B
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- attention deficit hyperactivity disorder, executive function, OROS MPH, atomoxetine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 9 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OROS MPH | Experimental | Drug: OROS MPHthe group treated by OROS MPH |
| atomoxetine | Active comparator | Drug: Atomoxetinethe group treated by atomoxetine |
| control | No intervention | –the normal control with no intervention |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OROS MPHAlso: ConcertaThe 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 | Drug | OROS MPH |
| AtomoxetineAlso: StratteraThe 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. | Drug | atomoxetine |
Primary outcome
Executive function test
Time frame: seven to ten weeks
1 secondary outcome
ADHD Rating Scale-IV
Time frame: seven to ten weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
- Derived from this study: PubMed 26779845Su 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.
- Derived from this study: PubMed 22017969Yang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yufeng Wang, M.D. PH.D. principal investigator
Peking University Institute of Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OROS MPH and Atomoxetine in people with Attention Deficit Hyperactivity Disorder, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive function test (time frame: seven to ten weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01065259, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2011; AzTrials last refreshed its copy on 31 Oct 2026.