Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children

NCT ID: NCT00254462

Last Updated: 2023-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-01
• Study Completion Date: 2008-09-01

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

atomoxetine and parent training

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

Group Type: EXPERIMENTAL

Atomoxetine

Intervention Type: DRUG

Participants will receive atomoxetine for 8 weeks up to a maximum of 1.8 mg/kg/day. Dosed once daily in capsule formulation.

Parent Training

Intervention Type: BEHAVIORAL

All children will receive parent training for the duration of the study.

placebo and parent training

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will receive placebo for 8 weeks. Dosed once daily, capsule formulation.

Parent Training

Intervention Type: BEHAVIORAL

All children will receive parent training for the duration of the study.

Interventions

Atomoxetine

Participants will receive atomoxetine for 8 weeks up to a maximum of 1.8 mg/kg/day. Dosed once daily in capsule formulation.

Intervention Type: DRUG

Placebo

Participants will receive placebo for 8 weeks. Dosed once daily, capsule formulation.

Intervention Type: DRUG

Parent Training

All children will receive parent training for the duration of the study.

Intervention Type: BEHAVIORAL

Other Intervention Names

Strattera; Pill placebo; Psychosocial and educational intervention

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-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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher J Kratochvil, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

New York State Psychiatric Institute

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

Kratochvil CJ, Vaughan BS, Stoner JA, Daughton JM, Lubberstedt BD, Murray DW, Chrisman AK, Faircloth MA, Itchon-Ramos NB, Kollins SH, Maayan LA, Greenhill LL, Kotler LA, Fried J, March JS. A double-blind, placebo-controlled study of atomoxetine in young children with ADHD. Pediatrics. 2011 Apr;127(4):e862-8. doi: 10.1542/peds.2010-0825. Epub 2011 Mar 21.

Reference Type: RESULT

PMID: 21422081 (View on PubMed)

Other Identifiers

K23MH066127

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0164-03-FB

Identifier Type: -

Identifier Source: org_study_id