Trial Outcomes & Findings for Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children (NCT NCT00254462)

Last Updated: 2023-10-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

93 participants

Primary outcome timeframe

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

Results posted on

2023-10-02

Participant Flow

Subjects were recruited in outpatient child psychiatry clinics at 3 academic institutions between October, 2005 and June 2008.

The ADHD diagnosis was confirmed using standardized measures and cases were reviewed on conference calls by professionals from all 3 sites.

Participant milestones

Participant milestones
Measure	Atomoxetine Recommended dosing of once per day, with divided dosing allowed at investigators discretion. Maximum dose of 1.8 mg/kg/day.	Placebo Recommended dosing of once per day, with divided dosing allowed at investigators discretion.
Overall Study STARTED	44	49
Overall Study COMPLETED	36	39
Overall Study NOT COMPLETED	8	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atomoxetine n=44 Participants Recommended dosing once daily, divided dosing at investigator discretion. Maximum dose of 1.8 mg/kg/day.	Placebo n=49 Participants Recommended dosing once daily, divided dosing at investigator discretion.	Total n=93 Participants Total of all reporting groups
Age, Categorical <=18 years	44 Participants n=93 Participants	49 Participants n=4 Participants	93 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	6.1 years STANDARD_DEVIATION 0.6 • n=93 Participants	6.1 years STANDARD_DEVIATION 0.5 • n=4 Participants	6.1 years STANDARD_DEVIATION 0.5 • n=27 Participants
Sex: Female, Male Female	12 Participants n=93 Participants	18 Participants n=4 Participants	30 Participants n=27 Participants
Sex: Female, Male Male	32 Participants n=93 Participants	31 Participants n=4 Participants	63 Participants n=27 Participants
Region of Enrollment United States	44 participants n=93 Participants	49 participants n=4 Participants	93 participants n=27 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Atomoxetine n=44 Participants Recommended dosing once daily, allowed to give in divided dose at investigator discretion. Maximum dose of 1.8 mg/kg/day.	Placebo n=49 Participants Recommended dosing once daily, allowed to give in divided dose at investigator discretion.
Change in ADHD-IV Rating Scale Total Score	-13.2 units on a scale Standard Error 1.7	-5.8 units on a scale Standard Error 1.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Atomoxetine n=44 Participants Recommended dosing once daily, allowed to give in divided dose at investigator discretion. Maximum dose of 1.8 mg/kg/day.	Placebo n=49 Participants Recommended dosing once daily, allowed to give in divided dose at investigator discretion.
Change in Total ADHD-IV Teacher	-12.5 units on a scale Standard Error 1.7	-5.0 units on a scale Standard Error 1.4

Adverse Events

Atomoxetine

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Atomoxetine n=44 participants at risk Recommended dosing once daily, divided dosing at investigator discretion. Maximum dose of 1.8 mg/kg/day.	Placebo n=49 participants at risk Recommended dosing once daily, divided dosing at investigator discretion.
General disorders aches/pains	13.6% 6/44 • 8 weeks	14.3% 7/49 • 8 weeks
Psychiatric disorders affective flattening/blunting	4.5% 2/44 • 8 weeks	4.1% 2/49 • 8 weeks
Psychiatric disorders attention/hyperactivity	6.8% 3/44 • 8 weeks	12.2% 6/49 • 8 weeks
Gastrointestinal disorders decreased appetite	29.5% 13/44 • 8 weeks	8.2% 4/49 • 8 weeks
Skin and subcutaneous tissue disorders dermatological	13.6% 6/44 • 8 weeks	10.2% 5/49 • 8 weeks
Psychiatric disorders disruptive behavior	6.8% 3/44 • 8 weeks	8.2% 4/49 • 8 weeks
Gastrointestinal disorders gastrointestinal upset	38.6% 17/44 • 8 weeks	16.3% 8/49 • 8 weeks
General disorders insomnia	2.3% 1/44 • Number of events 3 • 8 weeks	6.1% 3/49 • Number of events 10 • 8 weeks
Psychiatric disorders mood lability	40.9% 18/44 • Number of events 58 • 8 weeks	22.4% 11/49 • Number of events 22 • 8 weeks
Respiratory, thoracic and mediastinal disorders respiratory	11.4% 5/44 • 8 weeks	8.2% 4/49 • 8 weeks
General disorders sedation	29.5% 13/44 • 8 weeks	10.2% 5/49 • 8 weeks
General disorders weight loss	4.5% 2/44 • 8 weeks	4.1% 2/49 • 8 weeks

Additional Information

Christopher J. Kratochvil

University of Nebraska Medical Center

Phone: 402-552-6005

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place