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

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Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children

This study is ongoing, but not recruiting participants.

Study NCT00254462. Last updated on August 28, 2008. Information provided by National Institute of Mental Health (NIMH)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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 ]

Condition ^†

Attention Deficit Disorder With Hyperactivity

Intervention ^†

Drug: Atomoxetine
Drug: Placebo
Behavioral: Parent Training

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Start Date ^†

October 2005

Completion Date

February 2009

Eligibility Criteria ^†

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 ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00254462

Organization ID

K23 MH66127

Secondary IDs ^††

DDTR BK-TKND

Study Sponsor ^†

National Institute of Mental Health (NIMH)

Collaborators ^††

Investigators ^†

Principal Investigator:

Christopher J. Kratochvil, MD

University of Nebraska

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

August 2008

First Received Date ^†

November 14, 2005

Last Updated Date

August 28, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.