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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH066127 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will evaluate the effectiveness of atomoxetine in reducing the symptoms of attention deficit hyperactivity disorder (ADHD) in young children.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| atomoxetine and parent training | Experimental | atomoxetine capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks |
|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher J Kratochvil, MD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States | ||
| New York State Psychiatric Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21422081 | Result | 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. |
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The ADHD diagnosis was confirmed using standardized measures and cases were reviewed on conference calls by professionals from all 3 sites.
Subjects were recruited in outpatient child psychiatry clinics at 3 academic institutions between October, 2005 and June 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atomoxetine | Recommended dosing of once per day, with divided dosing allowed at investigators discretion. Maximum dose of 1.8 mg/kg/day. |
| FG001 | Placebo | Recommended dosing of once per day, with divided dosing allowed at investigators discretion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atomoxetine | Recommended dosing once daily, divided dosing at investigator discretion. Maximum dose of 1.8 mg/kg/day. |
| BG001 | Placebo | Recommended dosing once daily, divided dosing at investigator discretion. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | units on a scale | Measured at baseline and at Week 8. These are the only two timepoints calculated, later timepoint subtracted from earlier timepoint. |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atomoxetine | Recommended dosing once daily, divided dosing at investigator discretion. Maximum dose of 1.8 mg/kg/day. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| aches/pains | General disorders | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher J. Kratochvil | University of Nebraska Medical Center | 402-552-6005 | ckratoch@unmc.ed |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Participants will receive placebo for 8 weeks. Dosed once daily, capsule formulation. |
|
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| Parent Training | Behavioral | All children will receive parent training for the duration of the study. |
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| New York |
| New York |
| 10032 |
| United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Recommended dosing once daily, allowed to give in divided dose at investigator discretion.
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| 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. | Posted | Mean | Standard Error | units on a scale | Measured at baseline and at Week 8. Later time point is subtracted from earlier time point. |
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|
| 0 |
| 44 |
| 18 |
| 44 |
| EG001 | Placebo | Recommended dosing once daily, divided dosing at investigator discretion. | 0 | 49 | 11 | 49 |
| affective flattening/blunting | Psychiatric disorders | Non-systematic Assessment |
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| attention/hyperactivity | Psychiatric disorders | Non-systematic Assessment |
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| decreased appetite | Gastrointestinal disorders | Non-systematic Assessment |
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| dermatological | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| disruptive behavior | Psychiatric disorders | Non-systematic Assessment |
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| gastrointestinal upset | Gastrointestinal disorders | Non-systematic Assessment |
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| insomnia | General disorders | Non-systematic Assessment |
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| mood lability | Psychiatric disorders | Non-systematic Assessment |
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| respiratory | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| sedation | General disorders | Non-systematic Assessment |
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| weight loss | General disorders | Non-systematic Assessment |
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