Clinical Responses to Atomoxetine in Attention-Deficit/Hyperactivity Disorder: The Integrated Data Exploratory Analysis (IDEA) Study

Newcorn, Jeffrey H.; Sutton, Virginia K.; Weiss, Margaret; Sumner, Calvin R.

doi:10.1097/chi.0b013e31819c55b2

Cited by 75 publications

(64 citation statements)

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“…In none of the recent studies was a plateau reported for ATX clinical effects at or before 6 weeks (Block et al, 2009;Martényi et al, 2010;Montoya et al, 2009;Newcorn et al, 2009;Svanborg et al, 2009), with data somewhat supportive that time to optimal response may be at least 12 weeks. A critical finding in the treatment-naïve studies (Martényi et al, 2010;Montoya et al, 2009;Svanborg et al, 2009) was that effect size of ATX was greatest at study completion (6, 10, and 12 weeks, respectively), and in the Montoya study showed no sign of plateau even at 12 weeks (Montoya et al, 2009).…”

Section: Discussionmentioning

confidence: 99%

“…In non-treatment-naïve trials a 6-week study comparing morning and evening dosing with placebo reported significant improvement in ADHD-RS at 1 week in both dosing arms (Block et al, 2009), and an 8-week study reported improvement at week 2 but only in the 1.8 mg/kg cohort (Takahashi et al, 2009 In a post hoc analysis of two open-label studies (n=421) over 24 weeks using the Weekly Rating of Evening and Morning Behaviour (WREMB-R) and Global Impression of Perceived Difficulties (GIPD) scales, significant improvement was measured predominantly over the initial 2 weeks with maintenance over 24 weeks . The IDEA study pooled data from six ATX RCTs (n=618) (Newcorn et al, 2009). When compared with non-and moderate responders (>25% reduction in ADHD-RS), responders (>40% reduction in ADHD-RS), 47% of subjects, demonstrated significant improvement in ADHD-RS at 1 week with continuing divergence up to 9 weeks (p<0.001).…”

Section: Efficacy Time To Onset Of Response and Prediction Of Responsementioning

confidence: 99%

“…The IDEA study integrated post hoc analysis reported that in the responding cohort (>40% ADHD-RS reduction) the response was linear with no plateau in response by 9 weeks at trial cessation (Newcorn et al, 2009). In a pooled analysis of three open-label studies (n=338) of patients treated with ATX for 3, 6 and 12 months, although the median time to improvement was 3.7 weeks (>25% reduction in ADHD-RS), the median time to remission using the most stringent definition of CGI-ADHD-S ≤2 was 14.3 weeks with 75% probability at 52 weeks .…”

Section: Time To Full Response Randomised Double-blind Studies Threementioning

confidence: 99%

“…The IDEA study using the complete ADHD-RS scores after 4 weeks predicted that a treatment response of 25-40% reduction in ADHD-RS by Week 4 predicted achievement of an ultimate much improved response (defined as >40%) (positive predictive value (PPV)=75%; negative predictive value (NPV)=79%) (Newcorn et al, 2009). There were no other predictive clinical or demographic factors (60% responders, 40% non-responders).…”

Section: Prediction Of Responsementioning

confidence: 99%

“…Response prediction data are reported from two integrated post hoc analyses (Block et al, 2010;Newcorn et al, 2009). The IDEA study using the complete ADHD-RS scores after 4 weeks predicted that a treatment response of 25-40% reduction in ADHD-RS by Week 4 predicted achievement of an ultimate much improved response (defined as >40%) (positive predictive value (PPV)=75%; negative predictive value (NPV)=79%) (Newcorn et al, 2009).…”

Section: Prediction Of Responsementioning

confidence: 99%

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Systematic review of atomoxetine data in childhood and adolescent attention-deficit hyperactivity disorder 2009–2011: Focus on clinical efficacy and safety

Bushe

Savill

2013

J Psychopharmacol

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Background: Clinicians obtain critical prescribing knowledge from clinical papers and review articles. This is the first published systematic review of clinical atomoxetine data covering 2009-2011. Objective: We aim to update clinicians on current clinical atomoxetine data with specific reference to time of onset of efficacy and maximal efficacy. These data may allow critical analysis of comparative efficacy between atomoxetine and stimulant medications. Methods: A formal systematic review of atomoxetine data from January 2009-June 2011 was conducted. The search term used was "atomoxetine" in the English language. The search yielded 747 citations from which 106 are clinical data. This paper includes clinical efficacy and safety data and excludes quality-of-life and review papers. Results: Atomoxetine has an onset of action within 4 weeks (possibly within 1 week in subsequent responders) but requires at least 12 weeks for full response to be demonstrated. Treatment-naïve cohorts (6-12 weeks) report effect sizes of 0.6-1.3. Using minimum 6-week clinical trial criteria, atomoxetine may demonstrate similar efficacy to methylphenidate comparing reduction in core ADHD symptoms in meta-analysis, although the diversity of the data makes interpretation complex. From epidemiological databases, cardiovascular and suicide-related events were similar to those seen in patients taking methylphenidate. Conclusions:Incremental response time to atomoxetine should be considered in the design of future comparative efficacy trials.

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Section: Discussionmentioning

confidence: 99%

Section: Efficacy Time To Onset Of Response and Prediction Of Responsementioning

confidence: 99%

Section: Time To Full Response Randomised Double-blind Studies Threementioning

confidence: 99%

Section: Prediction Of Responsementioning

confidence: 99%

Section: Prediction Of Responsementioning

confidence: 99%

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Systematic review of atomoxetine data in childhood and adolescent attention-deficit hyperactivity disorder 2009–2011: Focus on clinical efficacy and safety

Bushe

Savill

2013

J Psychopharmacol

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Common and Unique Therapeutic Mechanisms of Stimulant and Nonstimulant Treatments for Attention-Deficit/Hyperactivity Disorder

Schulz

Fan²,

Bédard³

et al. 2012

Arch Gen Psychiatry

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CONTEXT Attention-deficit/hyperactivity disorder (ADHD) is a highly prevalent and impairing psychiatric disorder that affects both children and adults. There are Food and Drug Administration-approved stimulant and nonstimulant medications for treating ADHD; however, little is known about the mechanisms by which these different treatments exert their therapeutic effects. OBJECTIVE To contrast changes in brain activation related to symptomatic improvement with use of the stimulant methylphenidate hydrochloride vs the nonstimulant atomoxetine hydrochloride. DESIGN Functional magnetic resonance imaging before and after 6 to 8 weeks of treatment with methylphenidate (n = 18) or atomoxetine (n = 18) using a parallel-groups design. SETTING Specialized ADHD clinical research program at Mount Sinai School of Medicine, New York, New York. PARTICIPANTS Thirty-six youth with ADHD (mean [SD] age, 11.2 [2.7] years; 27 boys) recruited from randomized clinical trials. MAIN OUTCOME MEASURES Changes in brain activation during a go/no-go test of response inhibition and investigator-completed ratings on the ADHD Rating Scale-IV-Parent Version. RESULTS Treatment with methylphenidate vs atomoxetine was associated with comparable improvements in both response inhibition on the go/no-go test and mean (SD) improvements in ratings of ADHD symptoms (55% [30%] vs 57% [25%]). Improvement in ADHD symptoms was associated with common reductions in bilateral motor cortex activation for both treatments. Symptomatic improvement was also differentially related to gains in task-related activation for atomoxetine and reductions in activation for methylphenidate in the right inferior frontal gyrus, left anterior cingulate/supplementary motor area, and bilateral posterior cingulate cortex. These findings were not attributable to baseline differences in activation. CONCLUSIONS Treatment with methylphenidate and atomoxetine produces symptomatic improvement via both common and divergent neurophysiologic actions in frontoparietal regions that have been implicated in the pathophysiology of ADHD. These results represent a first step in delineating the neurobiological basis of differential response to stimulant and nonstimulant medications for ADHD.

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Neurodevelopmental Disorders: Attention‐Deficit/Hyperactivity Disorder

et al. 2015

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Clinical Responses to Atomoxetine in Attention-Deficit/Hyperactivity Disorder: The Integrated Data Exploratory Analysis (IDEA) Study

Cited by 75 publications

References 32 publications

Systematic review of atomoxetine data in childhood and adolescent attention-deficit hyperactivity disorder 2009–2011: Focus on clinical efficacy and safety

Systematic review of atomoxetine data in childhood and adolescent attention-deficit hyperactivity disorder 2009–2011: Focus on clinical efficacy and safety

Common and Unique Therapeutic Mechanisms of Stimulant and Nonstimulant Treatments for Attention-Deficit/Hyperactivity Disorder

Neurodevelopmental Disorders: Attention‐Deficit/Hyperactivity Disorder

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