Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children

Study Overview
=================
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.

Official Title
-----------------
Pharmacological Treatment of ADHD in Young Children

Conditions
-----------------
Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
-----------------
* Drug: Atomoxetine
* Drug: Placebo
* Behavioral: Parent Training


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: atomoxetine and parent training<br>atomoxetine capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks | Drug: Atomoxetine<br>* Participants will receive atomoxetine for 8 weeks up to a maximum of 1.8 mg/kg/day. Dosed once daily in capsule formulation.<br>* Other names: Strattera;Behavioral: Parent Training<br>* All children will receive parent training for the duration of the study.<br>* Other names: Psychosocial and educational intervention;|
| Placebo Comparator: placebo and parent training<br>matching placebo capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks | Drug: Placebo<br>* Participants will receive placebo for 8 weeks. Dosed once daily, capsule formulation.<br>* Other names: Pill placebo;Behavioral: Parent Training<br>* All children will receive parent training for the duration of the study.<br>* Other names: Psychosocial and educational intervention;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total ADHD-IV Teacher | Measures 18 symptoms of ADHD. Each symptom rated 0-3, for a maximum total score of 54 for the scale. A higher score reflects more severe symptomatology. | Measured at baseline and at Week 8. Later time point is subtracted from earlier time point. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADHD, Atomoxetine