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

NCT01065259 | Completed Phase 4 DMC

• 1 other identifier: CON-I-07-CN-029-B
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

attention deficit hyperactivity disorder; executive function; OROS MPH; atomoxetine

Outcome Measures

Primary Outcomes (1)

• Executive function test

  seven to ten weeks

Secondary Outcomes (1)

• ADHD Rating Scale-IV

  seven to ten weeks

Study Arms (3)

OROS MPH

EXPERIMENTAL

the group treated by OROS MPH

Drug: OROS MPH

atomoxetine

ACTIVE COMPARATOR

the group treated by atomoxetine

Drug: Atomoxetine

control

NO INTERVENTION

the normal control with no intervention

Interventions

OROS MPH DRUG

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

Also known as: Concerta

OROS MPH

Atomoxetine DRUG

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.

Also known as: Strattera

atomoxetine

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Sixth Hospital

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (2)

• 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.

  PMID: 26779845 DERIVED

• 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.

  PMID: 22017969 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate; Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propylamines; Amines

Study Officials

• Yufeng Wang, M.D. PH.D.

  Peking University Institute of Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 9, 2010
• Study Start: April 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 22, 2011

Record last verified: 2011-07

Locations

CN (1)