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. 2011 Jun;8(2):141-8.
doi: 10.4306/pi.2011.8.2.141. Epub 2011 Jan 19.

A Randomized, Open-Label Assessment of Response to Various Doses of Atomoxetine in Korean Pediatric Outpatients With Attention-Deficit/Hyperactivity Disorder

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Free PMC article

A Randomized, Open-Label Assessment of Response to Various Doses of Atomoxetine in Korean Pediatric Outpatients With Attention-Deficit/Hyperactivity Disorder

Soochurl Cho et al. Psychiatry Investig. .
Free PMC article

Abstract

Objective: This multicenter, randomized, open-label, parallel trial aimed to provide a detailed dose-response profile for atomoxetine in Korean pediatric outpatients with attention-deficit/hyperactivity disorder (ADHD).

Methods: Male and female outpatients aged 6-18 years with ADHD meeting symptom severity criteria of 1.5 standard deviations above age and gender norms on the ADHD Rating Scale-IV-Parent: Investigator-Administered and Scored (ADHDRS-IV-Parent: Inv), and a Clinical Global Impression-ADHD-Severity score ≥4 were randomized to atomoxetine (mg/kg/day) 0.2 fixed, 0.5 fixed or 0.5 (7 days), 0.8 (7 days) then 1.2 for 28 days. The primary efficacy measure was change in ADHDRS-IV-Parent: Inv total score after 6 weeks of atomoxetine treatment.

Results: Of 153 randomized patients, 83.7% were male and mean age was 9.8 (SD±2.4) years. The completion rate was 86.9%. A graded dose response was apparent with mean change in ADHDRS-IV-Parent: Inv total scores of -9.6, -12.3 and -14.5 with atomoxetine 0.2, 0.5 and 1.2 mg/kg/day, respectively (p=0.024 - F-test). Moreover, a greater reduction in ADHD symptoms, as assessed by mean change from baseline to endpoint CGI-S and mean CGI-ADHD-Improvement at endpoint, was also observed with increasing atomoxetine dose. More patients receiving atomoxetine 1.2 mg/kg/day reported ≥1 treatment-emergent adverse event/s (58.3%) compared with 0.5 (40.7%; p=0.11) or 0.2 mg/kg/day (29.4%; p=0.005). These were generally mild to moderate.

Conclusion: Atomoxetine was found to be safe and well tolerated at all doses administered in Korean pediatric ADHD patients, and 1.2 mg/kg/day was an efficacious dose in this population.

Keywords: ADHD; Atomoxetine; Dose response; Korea; Pediatric.

Figures

Figure 1
Figure 1
Patient disposition.
Figure 2
Figure 2
Graphical representation of the monotonic order of dose response to three doses of atomoxetine. ADHDRS-IV-Parent:Inv - Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent: Investigator-Administered and Scored. LOCF: last observation carried forward, LS: least squares, CL: confidence limits
Figure 3
Figure 3
Longitudinal change in systolic (A) and diastolic (B) blood pressure (mmHg) in patients receiving atomoxetine at a target dose of 1.2 mg/kg/day (Arm 3) and summary of mean change in vital signs from baseline to endpoint in all treatment arms.

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