Journal of the American Academy of Child & Adolescent Psychiatry
New ResearchClinical Responses to Atomoxetine in Attention-Deficit/Hyperactivity Disorder: The Integrated Data Exploratory Analysis (IDEA) Study
Section snippets
Analysis Framework
Integrated data exploratory analysis was a retrospective analysis of pooled data from the acute phases (6–9 weeks) of the six industry-sponsored U.S. randomized, double-blind, placebo-controlled trials of pediatric outpatients with ADHD (Table 1).2, 6, 7, 8, 23 These studies examined the effect of atomoxetine on symptom reduction as measured by the ADHD Rating Scale (ADHD-RS)24 total score as the primary outcome measure. The study designs, inclusion and exclusion criteria, and assessments in
Distribution of Responders and Nonresponders
A total of 60% of all patients had evidence of at least minimal clinical response to atomoxetine as indicated by a 25% or greater decline from baseline in the ADHD-RS total score. Of these, 78% (47% of all of the patients) had a 40% or greater decrease in the ADHD-RS total score. In contrast, 40% of the patients were nonresponders (i.e., <25% decrease in ADHD-RS total score). Only a relatively small proportion (13%) had a minimal response (i.e., 25%–<40% decrease in the ADHD-RS total score);
Discussion
The IDEA study found that the probability of responding to atomoxetine is relatively bimodal, with 47% of patients showing a much improved response, 13% showing minimal response, and 40% being nonresponders. This finding substantiates the clinical observation that there is considerable variability in patient response. However, this study failed to identify any demographic or clinical factors that were associated with these divergent profiles of response.
One factor that was found to be
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Predicting efficacy of viloxazine extended-release treatment in adults with ADHD using an early change in ADHD symptoms: Machine learning Post Hoc analysis of a phase 3 clinical trial
2022, Psychiatry ResearchCitation Excerpt :Based on the best selected model, lasso regression, using the change in the ADHD-RS-5 Total score at Week 2, we could select 75% of patients who would respond by Week 6. A predictive modeling study of another nonstimulant medication for ADHD, atomoxetine, used a pooled sample from six pediatric clinical trials and defined responders as having a ≥40% decrease in the ADHD Rating Scale, 4th Edition (ADHD-RS-IV) Total score (Newcorn et al., 2009). The model required 4 weeks of treatment to make a prediction that achieved a level of accuracy similar to what was found for viloxazine ER at 2 weeks using a response definition of ≥50% decrease in the ADHD-RS-5 (Faraone et al., 2021).
Nonstimulant Treatments for ADHD
2022, Child and Adolescent Psychiatric Clinics of North AmericaCitation Excerpt :Time to duration of onset of atomoxetine has been a matter of some debate. Newcorn and colleagues (2009)10 examined predictors of response in acute trials of atomoxetine in youth, finding that early response to atomoxetine (2–4 weeks) predicted response at trial endpoint. However, De Brukyere and colleagues (2016),11 using pooled data from short-term (10 weeks) and long-term (24 weeks) clinical trials in adults, found that although symptom reductions and global improvement scores at weeks 4 and 10 were statistically significant predictors of response at later time points, they did not fully account for improvement over time.
Methylphenidate and atomoxetine treatment negatively affect physical growth indexes of school-age children and adolescents with attention-deficit/hyperactivity disorder
2021, Pharmacology Biochemistry and BehaviorStriatal Activation Predicts Differential Therapeutic Responses to Methylphenidate and Atomoxetine
2017, Journal of the American Academy of Child and Adolescent PsychiatryCitation Excerpt :To our knowledge, these are the first findings to identify possible biomarker predictors of differential response to the stimulant methylphenidate over the nonstimulant atomoxetine, as well as overall response to atomoxetine in youth with ADHD. These candidate biomarkers may potentially be of interest to clinicians, given both the high level of nonresponse to atomoxetine and the extended time required to achieve optimal response to this medication.3 The findings have considerable promise for directing future research on personalized treatment of ADHD.
Funding for this research was provided by Eli Lilly and Company.
The authors thank Stephen W. Gutkin of Rete Biomedical Communications for assistance in manuscript preparation.
Clinical trials registration information—Evaluation of Continuous Symptom Treatment of ADHD: A Placebo-Controlled Double-Blind Assessment of Morning-Dosed or Evening-Dosed Strattera. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00486122. Results of the other studies analyzed in the Integrated Data Exploratory Analysis study are posted at www.clinicalstudyresults.org, ID numbers 5670, 7972, 2746, 1585, 1586, and 3468, and www.lillytrials.com.