Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children

University of Nebraska

Status and phase: Completed; Phase 4

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Drug: Placebo; Behavioral: Parent Training; Drug: Atomoxetine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00254462

K23MH066127 (U.S. NIH Grant/Contract)

0164-03-FB

Details and patient eligibility

About

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

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 5 to 6 years old

Volunteers: No Healthy Volunteers

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-Rating Scale (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 Intelligence Quotient (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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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93 participants in 2 patient groups, including a placebo group

atomoxetine and parent training

Experimental group

Description:

atomoxetine capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks

Treatment:

Drug: Atomoxetine

Behavioral: Parent Training

placebo and parent training

Placebo Comparator group

Description:

matching placebo capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks

Treatment:

Behavioral: Parent Training

Drug: Placebo