Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children

• Sponsor: University of Nebraska (Other)
• Overall Status: Completed
• CT.gov ID: NCT00254462
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 93
• Locations: 3
• Arms: 2
• Duration (Months): 35
• Patients Per Site: 31
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Disorder With Hyperactivity	Drug: Atomoxetine; Drug: Placebo; Behavioral: Parent Training	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 93 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pharmacological Treatment of ADHD in Young Children
• Study Start Date: Oct 1, 2005
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 6 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198
2	New York State Psychiatric Institute	New York	New York	United States	10032
3	Duke University Medical Center	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• University of Nebraska
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Christopher J. Kratochvil, MD, University of Nebraska

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Christopher J. Kratochvil, M.D., Professor Psychiatry and Pediatrics, University of Nebraska
• ClinicalTrials.gov Identifier: NCT00254462
• Other Study ID Numbers: K23MH066127; K23MH066127
• First Posted: Nov 16, 2005
• Last Update Posted: Dec 18, 2015
• Last Verified: Dec 1, 2015

• Keywords provided by Christopher J. Kratochvil, M.D., Professor Psychiatry and Pediatrics, University of Nebraska: ADHD; Atomoxetine
• Additional relevant MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Atomoxetine Hydrochloride

Study Results

Participant Flow

Recruitment Details	Subjects were recruited in outpatient child psychiatry clinics at 3 academic institutions between October, 2005 and June 2008.
Pre-assignment Detail	The ADHD diagnosis was confirmed using standardized measures and cases were reviewed on conference calls by professionals from all 3 sites.

Arm/Group Title	Atomoxetine	Placebo
Arm/Group Description	Recommended dosing of once per day, with divided dosing allowed at investigators discretion. Maximum dose of 1.8 mg/kg/day.	Recommended dosing of once per day, with divided dosing allowed at investigators discretion.
Period Title: Overall Study
STARTED	44	49
COMPLETED	36	39
NOT COMPLETED	8	10

Baseline Characteristics

Arm/Group Title	Atomoxetine	Placebo	Total
Arm/Group Description	Recommended dosing once daily, divided dosing at investigator discretion. Maximum dose of 1.8 mg/kg/day.	Recommended dosing once daily, divided dosing at investigator discretion.	Total of all reporting groups
Overall Participants	44	49	93
Age (Count of Participants)
<=18 years	44 100%	49 100%	93 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	6.1 (0.6)	6.1 (0.5)	6.1 (0.5)
Sex: Female, Male (Count of Participants)
Female	12 27.3%	18 36.7%	30 32.3%
Male	32 72.7%	31 63.3%	63 67.7%
Region of Enrollment (participants) [Number]
United States	44 100%	49 100%	93 100%

Outcome Measures

1. Primary Outcome

Title	Change in ADHD-IV Rating Scale Total Score
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Atomoxetine	Placebo
Arm/Group Description	Recommended dosing once daily, allowed to give in divided dose at investigator discretion. Maximum dose of 1.8 mg/kg/day.	Recommended dosing once daily, allowed to give in divided dose at investigator discretion.
Measure Participants	44	49
Mean (Standard Error) [units on a scale]	-13.2 (1.7)	-5.8 (1.2)

2. Secondary Outcome

Title	Change in Total ADHD-IV Teacher
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Atomoxetine	Placebo
Arm/Group Description	Recommended dosing once daily, divided dose at investigator discretion. Maximum daily dose of 1.8 mg/kg/day.	Recommended dosing once daily, divided dose at investigator discretion.
Measure Participants	44	49
Mean (Standard Error) [units on a scale]	-12.5 (1.7)	-5.0 (1.4)

Adverse Events

Arm/Group Title	Atomoxetine		Placebo
Arm/Group Description	Recommended dosing once daily, divided dosing at investigator discretion. Maximum dose of 1.8 mg/kg/day.		Recommended dosing once daily, divided dosing at investigator discretion.
All Cause Mortality
	Atomoxetine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Atomoxetine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/49 (0%)
Other (Not Including Serious) Adverse Events
	Atomoxetine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/44 (40.9%)		11/49 (22.4%)
Gastrointestinal disorders
decreased appetite	13/44 (29.5%)		4/49 (8.2%)
gastrointestinal upset	17/44 (38.6%)		8/49 (16.3%)
General disorders
aches/pains	6/44 (13.6%)		7/49 (14.3%)
insomnia	1/44 (2.3%)	3	3/49 (6.1%)	10
sedation	13/44 (29.5%)		5/49 (10.2%)
weight loss	2/44 (4.5%)		2/49 (4.1%)
Psychiatric disorders
affective flattening/blunting	2/44 (4.5%)		2/49 (4.1%)
attention/hyperactivity	3/44 (6.8%)		6/49 (12.2%)
disruptive behavior	3/44 (6.8%)		4/49 (8.2%)
mood lability	18/44 (40.9%)	58	11/49 (22.4%)	22
Respiratory, thoracic and mediastinal disorders
respiratory	5/44 (11.4%)		4/49 (8.2%)
Skin and subcutaneous tissue disorders
dermatological	6/44 (13.6%)		5/49 (10.2%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.