An Open-Label, Dose-Ranging Study of Atomoxetine in Children with Attention Deficit Hyperactivity Disorder

Spencer, Thomas; Biederman, Joseph; Heiligenstein, John H.; Wilens, Timothy E.; Faries, Douglas E.; Prince, Jefferson B.; Faraone, Stephen V.; Rea, Jackie; Witcher, Jennifer; Zervas, Stephanie

doi:10.1089/10445460152595577

Cited by 137 publications

(78 citation statements)

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“…When the data from the ADHD RS Total Score were examined using a visit-wise analysis, atomoxetine produced statistically significant efficacy at the first week after randomization that continued for the remainder of the study. These data demonstrating significant efficacy for atomoxetine in school-age girls with ADHD extend data from studies that have shown that atomoxetine is efficacious in boys and girls as well as in men and women with ADHD 15,16,24 (Spencer et al, unpublished data). In addition to demonstrating significant differences on investigator-scored measures, atomoxetine resulted in a significant decrease on a well-validated parentage rating scale, the CPRS-R.…”

Section: Discussionsupporting

confidence: 72%

Efficacy of Atomoxetine Versus Placebo in School-Age Girls With Attention-Deficit/Hyperactivity Disorder

et al. 2002

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ABSTRACT. Objective. The efficacy of atomoxetine was assessed in school-age girls with attention-deficit/ hyperactivity disorder (ADHD). Atomoxetine is a potent inhibitor of the presynaptic norepinephrine transporter with minimal affinity for other noradrenergic receptors or for other neurotransmitter transporters or receptors.Methods. A total of 291 children who were 7 to 13 years of age and met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for ADHD participated in 1 of 2 combined, double-blind, placebo-controlled, multisite, identical clinical trials. This intent-totreat subset analysis examined the effects of atomoxetine versus placebo in 51 girls who were randomized to atomoxetine (n ‫؍‬ 30) or placebo (n ‫؍‬ 21) for 9 weeks. ADHD symptoms were assessed using parent-and investigatorrated scales.Results. Atomoxetine was superior to placebo on the following measures: the Attention-Deficit Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored Total Score; the Inattentive and Hyperactive/Impulsive subscales of the Attention-Deficit Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored Total Score; the ADHD Index subscale of the Conners' Parent Rating Scale-Revised: Short Form; and the Clinical Global Impressions of Severity of ADHD. Statistically significant efficacy was seen 1 week after randomization and remained so for the duration of the study. One patient from each of the atomoxetine and placebo groups discontinued the study as a result of an adverse event.Conclusion. Atomoxetine was found to be effective and well tolerated for the treatment of ADHD in schoolage girls. Pediatrics 2002;110(6). URL: http://www.pediatrics. org/cgi/content/full/110/6/e75; atomoxetine, ADHD, schoolage, girls, nonstimulant.ABBREVIATIONS. ADHD, attention-deficit/hyperactivity disorder; DSM-IV, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition; ADHD RS, Attention-Deficit Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored Total Score; SD, standard deviation; CPRS-R, Conners' Parent Rating Scale-Revised: Short Form; CGI-ADHD-S, Clinical Global Impressions of Severity of ADHD.A ttention-deficit/hyperactivity disorder (ADHD) is an early-onset childhood disorder that is estimated to occur in 3% to 7% of school-age children. 1 Its pathophysiology seems to involve the interaction of norepinephrine, epinephrine, and dopamine in modulation of attention and impulsivity. 2 ADHD is frequently associated with impaired academic and social functioning and persists into adulthood in a sizable number of affected youths. 3 Literature on the efficacy of pharmacologic treatment in school-age children with ADHD has focused almost exclusively on boys. There is a paucity of data reporting findings of the pharmacologic treatment of ADHD in school-age girls, most likely because many more boys with ADHD are referred for treatment. The Diagnostic and Statistical Manual of Mental Disorders, F...

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Section: Discussionsupporting

confidence: 72%

Efficacy of Atomoxetine Versus Placebo in School-Age Girls With Attention-Deficit/Hyperactivity Disorder

et al. 2002

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“…Atomoxetine significantly reduced core symptoms of ADHD in an openlabel study in children . Overall, it was well tolerated in the child and adolescent age group (Michelson et al 2001;Spencer et al 2001). Atomoxetine has also been shown in a 6-week open label study to produce clinically significant improvement in the symptoms in patients with major depression (Chouinard et al 1984).…”

mentioning

confidence: 94%

Atomoxetine Increases Extracellular Levels of Norepinephrine and Dopamine in Prefrontal Cortex of Rat A Potential Mechanism for Efficacy in Attention Deficit/Hyperactivity Disorder

Bymaster

Katner

Nelson

et al. 2002

Neuropsychopharmacology

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“…Following a small open-label dose ranging study, 15 a large randomized controlled trial demonstrated superior effi cacy of 1.2 mg/kg/day and 1.8 mg/kg/day doses compared with placebo. 16 This multicenter 8-week trial included 297 children and adolescents with ADHD.…”

Section: Effi Cacymentioning

confidence: 99%

Atomoxetine for the treatment of attention-deficit/hyperactivity disorder in children and adolescents: a review

Hammerness¹,

McCarthy²,

Mancuso³

et al. 2009

NDT

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Objective: This review examines and summarizes the pharmacodynamic and pharmacokinetic properties, short-and longer-term effi cacy, the moderating effect of comorbid disorders, as well as short-and long-term safety and tolerability of atomoxetine for the treatment of pediatric attention-defi cit/hyperactivity disorder (ADHD). Methods: A systematic literature search was performed to review the extant literature on articles pertaining to the pharmacological treatment with atomoxetine in pediatric and/or adolescent ADHD. Results: There is an extensive literature on atomoxetine; over 4000 children have participated in clinical trials of atomoxetine, demonstrating its short-and longer-term effi cacy. In addition, studies have examined the moderating effect of comorbid disorders on atomoxetine response, as well as atomoxetine's therapeutic potential for other psychiatric conditions. Short-and longerterm safety and tolerability continue to be reported. Conclusions: Atomoxetine is indicated for both acute and maintenance/extended treatment of pediatric ADHD. Clinicians and families must be familiar with atomoxetine's evidence base, including its profi le of clinical response and its possible effectiveness in the presence of comorbidity.

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An Open-Label, Dose-Ranging Study of Atomoxetine in Children with Attention Deficit Hyperactivity Disorder

Abstract: These findings extend to children the positive results previously reported in adults diagnosed with ADHD who were treated with atomoxetine. These results support additional controlled trials of atomoxetine in cases of pediatric ADHD.

Cited by 137 publications

References 6 publications

Efficacy of Atomoxetine Versus Placebo in School-Age Girls With Attention-Deficit/Hyperactivity Disorder

Efficacy of Atomoxetine Versus Placebo in School-Age Girls With Attention-Deficit/Hyperactivity Disorder

Atomoxetine Increases Extracellular Levels of Norepinephrine and Dopamine in Prefrontal Cortex of Rat A Potential Mechanism for Efficacy in Attention Deficit/Hyperactivity Disorder

Atomoxetine for the treatment of attention-deficit/hyperactivity disorder in children and adolescents: a review

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