Study of Atomoxetine and OROS Methylphenidate to Treat Children and Adolescents Ages 6-17 With ADHD - Full Text View

Sponsored by:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00585910

Purpose

The purpose of this study is to evaluate the safety, effectiveness, and tolerability of atomoxetine and OROS methylphenidate, taken together, in the treatment of ADHD in children and adolescents ages 6-17.

Condition	Intervention	Phase
ADHD Attention Deficit Hyperactivity Disorder	Drug: Atomoxetine and OROS Methylphenidate	Phase IV

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate hydrochloride Methylphenidate Atomoxetine Atomoxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety/Tolerability of OROS MPH (Concerta) Plus Atomoxetine (ATMX) in Children and Adolescents (Age 6-17) With Attention Deficit Hyperactivity Disorder (ADHD)

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

The primary outcome will be the ADHD rating scale. Change scores for the ADHD RS, from baseline to endpoint (week 7 or last observation carried forward), will be analyzed with paired t-tests and nonparametric Wilcoxon sign-rank tests. [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary analyses will allow us to evaluate the effects of treatment on additional measures of functioning (CGIs for ADHD and other psychiatric disorders) as well as vital signs. [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Enrollment:	94
Study Start Date:	January 2004
Estimated Study Completion Date:	December 2007
Estimated Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Total treatment period is 7 weeks. Atomoxetine treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate will then be added to his or her treatment regimen for the final 3 weeks of the study.	Drug: Atomoxetine and OROS Methylphenidate Subjects must have at least attempted to tolerate a dose of 1.2 mg/kg of atomoxetine. If tolerated, they must remain on this dose for at least two weeks. OROS methylphenidate will be target dosed and titrated to a maximum dose of 54 mg.

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female outpatients from 6 to 17.
Subjects with a DSM-IV diagnosis of ADHD by clinical interview, confirmed by the KSADS-E ADHD module.
Subject with DSM-IV diagnosis of ADHD without previous treatment.
Subjects with DSM-IV diagnosis of ADHD with a clinical history of a partial response to ATMX or methylphenidate as monotherapy.
In phase I, subjects with a CGI-Severity of at least moderate impairment related to their ADHD (CGI >4).
In phase II, subjects receiving therapeutic doses of ATMX with at least minor improvement in their clinical picture due to the ATMX as determined operationally (CGI-Improvement score indicating at least minor improvement relative to off-drug baseline) will be included.
In phase II, only subjects receiving ATMX that also have evidence of persistent symptoms of ADHD and impairment related to their ADHD (a CGI-Severity of > minor impairment OR ADHD RS >18; AND GAF score <65) will have Concerta added to their regimen.
Subjects' parents must provide informed consent and subjects' assent.

Exclusion Criteria:

Pregnant or nursing females or females not using proper contraception.
Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study.
Subjects (or their families) who do not appear to be reliable reporters of their condition or who indicate they will not be able to meet the schedule of visits for the duration of the study.
Subjects with Mental Retardation or Organic Brain Syndromes.
Subjects who have a lifetime history of a psychotic or bipolar disorder.
Subjects with recent or current (past 30 days) major depressive disorder or a clinically significant anxiety disorder that would potentially necessitate treatment during the trial. g. Subjects with recent evidence (past 30 days) of suicidality or homicidality will not be enrolled.
Subjects with a recent history (e.g. three months) of a substance use disorder; or those with a positive urine for substances of abuse will not be enrolled. Subjects will be told that a positive urine for substances of abuse will be disclosed to their parents.
Subjects taking stimulants or other psychotropics at the time of the evaluation. Subjects will not be discontinued from their current medication regimen (not including ATMX), unless authorized and supervised by their treating physician.
Treatment of stimulants within one week of the evaluation; tricyclic antidepressants, bupropion, cholinesterase inhibitors, modafinil, clonidine/guanfacine, lithium/anticonvulsants for behavioral control, or serotonin reuptake inhibitors (except fluoxetine) for four weeks prior to entry are prohibited. Treatment with antipsychotics/neuroleptics and fluoxetine for 8 weeks prior to entry are prohibited.
Subjects using any prescribed or over-the-counter concurrent treatment for ADHD.
Subjects with a history of a lack of response to either ATMX or methylphenidate.
Subjects with a history of a serious adverse event to either ATMX or methylphenidate.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585910

Locations

United States, Massachusetts
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:

Timothy Wilens, MD

Massachusetts General Hospital

More Information

Responsible Party:	Massachusetts General Hospital ( Timothy Wilens, MD )
Study ID Numbers:	2003-P-002180
Study First Received:	December 21, 2007
Last Updated:	January 3, 2008
ClinicalTrials.gov Identifier:	NCT00585910
Health Authority:	United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:

ADHD
Attention Deficit Hyperactivity Disorder
Strattera

Concerta
Atomoxetine
OROS Methylphenidate

Study placed in the following topic categories:

Signs and Symptoms
Dopamine
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Atomoxetine

Methylphenidate
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Disease
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Nervous System Diseases

Physiological Effects of Drugs
Central Nervous System Stimulants
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009