A Study for Patients With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00471354

Purpose

The purpose of the study is to investigate the relationship of changes in measures of academic performance and problem behaviors, to changes in core Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in Asian children treated with atomoxetine.

Condition	Intervention	Phase
Attention Deficit Hyperactivity Disorder	Drug: Atomoxetine	Phase IV

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Atomoxetine hydrochloride Atomoxetine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Evaluation of Academic Performance in Asian Children Aged 8 to 11 Years With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine Hydrochloride

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Correlation between ADHD symptoms by Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) total score with academic performance by School Grade Average [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Correlation between ADHD symptoms by ADHDRS-IV-Parent:Inv total score with academic performance in each of the school grades for language, Maths and Science classes [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Academic performance by School Grade Average (SGA) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
ADHDRS-IV-Parent:Inv total score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder - Severity scale (CGI-ADHD-S) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
CGI-ADHD-Improvement scale (CGI-ADHD-I) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Revised Conners' Parent Rating Scale: Short Form (CPRS-R:S) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	234
Study Start Date:	April 2007
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Atomoxetine atomoxetine 0.5 mg/kg/day QD, PO starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.

Eligibility

Ages Eligible for Study:	8 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female outpatients between 8 and 11 years of age at study entry
ADHD meeting the DSM-IV-TR disease diagnostic criteria
Patients who have never received medications psychotropic medications specifically to treat ADHD, or if they have received medication, that the trial of the psychotropic medication(s) was of less than 1 month duration, and occurred more than 6 months prior to study entry
Normal intelligence in the judgment of the investigator
Must be able to swallow capsules

Exclusion Criteria:

Current or past history of bipolar I or II disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, or conduct disorder
History of seizure disorder or currently taking anticonvulsants for seizure control
Serious suicidal risk as determined by investigator
Cardiovascular disease; current or past history of hypertension
Previous treatment with atomoxetine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471354

Locations

China
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Beijing, China, 100088
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Shanghai, China, 200127
Korea, Republic of
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Pusan, Korea, Republic of, 609-739
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seoul, Korea, Republic of, 138-736
Taiwan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tao-Yuan, Taiwan, 333
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Neihu Taipei, Taiwan, 114
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Taipei, Taiwan, 100
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Niao Sung Hsiang, Taiwan, 833

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	ELi Lilly ( Chief Medical Officer )
Study ID Numbers:	11098, B4Z-CR-S018
Study First Received:	May 7, 2007
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00471354 History of Changes
Health Authority:	China: Ethics Committee; Korea: Food and Drug Administration; Taiwan: Institutional Review Board

Study placed in the following topic categories:

Signs and Symptoms
Neurotransmitter Agents
Adrenergic Agents
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood

Atomoxetine
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Atomoxetine

Dyskinesias
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations

ClinicalTrials.gov processed this record on May 07, 2009