Attention Deficit Disorder With Hyperactivity
Conditions
Keywords
ADHD, Atomoxetine
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.
Interventions
DRUGAtomoxetine
Participants will receive atomoxetine for 8 weeks up to a maximum of 1.8 mg/kg/day. Dosed once daily in capsule formulation.
DRUGPlacebo
Participants will receive placebo for 8 weeks. Dosed once daily, capsule formulation.
BEHAVIORALParent Training
All children will receive parent training for the duration of the study.
Sponsors
National Institute of Mental Health (NIMH)
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ADHD-IV Rating Scale Total Score | Measured at baseline and at Week 8. These are the only two timepoints calculated, later timepoint subtracted from earlier timepoint. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total ADHD-IV Teacher | Measured at baseline and at Week 8. Later time point is subtracted from earlier time point. | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited in outpatient child psychiatry clinics at 3 academic institutions between October, 2005 and June 2008.
Pre-assignment details
The ADHD diagnosis was confirmed using standardized measures and cases were reviewed on conference calls by professionals from all 3 sites.
Participants by arm
| Arm | Count |
|---|---|
| Atomoxetine Recommended dosing once daily, divided dosing at investigator discretion. Maximum dose of 1.8 mg/kg/day. | 44 |
| Placebo Recommended dosing once daily, divided dosing at investigator discretion. | 49 |
| Total | 93 |
Baseline characteristics
| Characteristic | Placebo | Atomoxetine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 49 Participants | 44 Participants | 93 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 6.1 years STANDARD_DEVIATION 0.5 | 6.1 years STANDARD_DEVIATION 0.6 | 6.1 years STANDARD_DEVIATION 0.5 |
| Region of Enrollment United States | 49 participants | 44 participants | 93 participants |
| Sex: Female, Male Female | 18 Participants | 12 Participants | 30 Participants |
| Sex: Female, Male Male | 31 Participants | 32 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 44 | 11 / 49 |
| serious Total, serious adverse events | 0 / 44 | 0 / 49 |
Outcome results
Primary
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.
Time frame: Measured at baseline and at Week 8. These are the only two timepoints calculated, later timepoint subtracted from earlier timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atomoxetine | Change in ADHD-IV Rating Scale Total Score | -13.2 units on a scale | Standard Error 1.7 |
| Placebo | Change in ADHD-IV Rating Scale Total Score | -5.8 units on a scale | Standard Error 1.2 |
Secondary
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.
Time frame: Measured at baseline and at Week 8. Later time point is subtracted from earlier time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atomoxetine | Change in Total ADHD-IV Teacher | -12.5 units on a scale | Standard Error 1.7 |
| Placebo | Change in Total ADHD-IV Teacher | -5.0 units on a scale | Standard Error 1.4 |