Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children - Tabular View

Tracking Information

First Received Date ^ICMJE

November 14, 2005

Last Updated Date

August 28, 2008

Start Date ^ICMJE

October 2005

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

ADHD-IV Rating Scale total score [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

ADHD-IV Rating Scale total score; measured at Week 8

Change History

Complete list of historical versions of study NCT00254462 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Conners Parent Rating Scale & Conners Teacher Rating Scale [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
ADHD-IV Teacher [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
CGI-I and CGI-S and CGAS [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
Emotional Expression Scale for Children [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
Parent Stress Index [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children

Official Title ^ICMJE

Pharmacological Treatment of ADHD in Young Children

Brief Summary

This study will evaluate the effectiveness of atomoxetine in reducing the symptoms of attention deficit hyperactivity disorder (ADHD) in young children.

Detailed Description

Attention deficit hyperactivity disorder (ADHD) is one of the most common mental disorders in children. Children with ADHD often have impaired functioning in home and school and usually experience difficulty relating to peers. If left untreated, the disorder can have long-term adverse effects into adolescence and adulthood. Atomoxetine is a selective noradrenergic reuptake inhibitor that is FDA-approved for the treatment of ADHD in children, adolescents, and adults. Unlike most other medications for ADHD, atomoxetine is not a stimulant. Studies have shown that atomoxetine is effective in treating ADHD, but more information is needed on its effectiveness in young children. This study will evaluate the effectiveness of atomoxetine in reducing the symptoms of ADHD in young children.

Participants in this double-blind study will be randomly assigned to receive either atomoxetine or placebo for 8 weeks. In addition, all children will receive parent training for the duration of the study. For the first 5 weeks, participants will report to the study site weekly for assessments of ADHD symptoms. Study visits will occur every other week for the remainder of the study.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Attention Deficit Disorder With Hyperactivity

Intervention ^ICMJE

Drug: Atomoxetine
Drug: Placebo
Behavioral: Parent Training

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2009

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Parent and child must be English speaking
Child has been living with parent/guardian for at least six months
Meets criteria for ADHD on the DISC, on clinical interview, and on clinical consensus conference
ADHD is primary disorder with symptoms present for at least 9 months
ADHD-IV-RS score that is at least 1.5 standard deviations above age and sex norms
Score of 55 or below on the Children's Global Assessment Scale
Score of 4 or greater on the Clinical Global Impression Scale
Estimated IQ of 70 or greater
Currently participating in school at least 2 half-days per week
Able to identify a teacher who can make valid assessments
Patient and parent are able to attend regular study visits

Exclusion Criteria:

Currently taking other psychotropic medications or other medications with effects on the central nervous system
Currently being treated effectively with atomoxetine
Major medical conditions that might interfere with study medications
History of or current clinically significant kidney illness
Evidence of adjustment disorder, autism, psychosis, bipolar disorder, suicide ideations, or any other psychiatric disorder requiring treatment with additional psychotropic medication
History of physical, sexual, or emotional abuse impacting clinical presentation
Prior failure to respond to an adequate trial of atomoxetine

Gender

Both

Ages

5 Years to 6 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00254462

Responsible Party

Christopher J. Kratochvil, MD, University of Nebraska Medical Center

Study ID Numbers ^ICMJE

K23 MH66127, DDTR BK-TKND

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Christopher J. Kratochvil, MD

University of Nebraska

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP