Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children

NCT00254462 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: 0164-03-FBK23MH066127
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

ADHD; Atomoxetine

Outcome Measures

Primary Outcomes (1)

• Change in ADHD-IV Rating Scale Total Score

  Measures 18 symptoms of attention deficit hyperactivity disorder (ADHD). Each symptom rated 0-3, for a minimum total score of 0, and a maximum total score of 54 for the scale. A higher score reflects more severe symptomatology. The inattentive subscale and the hyperactive/impulsive subscale each has a minimum score of 0 and maximum score of 27.

  Measured at baseline and at Week 8. These are the only two timepoints calculated, later timepoint subtracted from earlier timepoint.

Secondary Outcomes (1)

• Change in Total ADHD-IV Teacher

  Measured at baseline and at Week 8. Later time point is subtracted from earlier time point.

Study Arms (2)

atomoxetine and parent training

EXPERIMENTAL

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

Drug: Atomoxetine; Behavioral: Parent Training

placebo and parent training

PLACEBO COMPARATOR

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

Drug: Placebo; Behavioral: Parent Training

Interventions

Atomoxetine DRUG

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

Also known as: Strattera

atomoxetine and parent training

Placebo DRUG

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

Also known as: Pill placebo

placebo and parent training

Parent Training BEHAVIORAL

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

Also known as: Psychosocial and educational intervention

atomoxetine and parent training; placebo and parent training

Eligibility Criteria

• Age: 5 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• 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.

  PMID: 21422081 RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Limitations and Caveats

Study design does not allow differentiation between placebo response and psychoeducational treatment effect. Eight-week duration does not allow for examination of long-term effectiveness or assessment of adverse effects over time.

Results Point of Contact

• Title: Christopher J. Kratochvil
• Organization: University of Nebraska Medical Center

ckratoch@unmc.ed

402-552-6005

Study Officials

• Christopher J Kratochvil, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2005
• First Posted: November 16, 2005
• Study Start: October 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: September 1, 2008
• Last Updated: October 2, 2023
• Results First Posted: July 17, 2013

Record last verified: 2023-09

Locations

US (3)