Atomoxetine Treatment of Attention-Deficit/Hyperactivity Disorder in Young Adults With Assessment of Functional Outcomes: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Durell, Todd M.; Adler, Lenard A.; Williams, Dave W.; Deldar, Ahmed; McGough, James J.; Glaser, Paul E.; Rubin, Richard L.; Pigott, Teresa A.; Sarkis, Elias H.; Fox, Bethany K.

doi:10.1097/jcp.0b013e31827d8a23

Cited by 64Attention Deficit Hyperactivity DisorderSchizophrenia research and treatmentSubstance Abuse Treatment and Outcomes

Atomoxetine Treatment of Attention-Deficit/Hyperactivity Disorder in Young Adults With Assessment of Functional Outcomes: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Durell, Todd M., Adler, Lenard A., Williams, Dave W., Deldar, Ahmed, McGough, James J., Glaser, Paul E., Rubin, Richard L., Pigott, Teresa A. +2 more·2013·Journal of Clinical Psychopharmacology

DOI 10.1097/jcp.0b013e31827d8a23

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Abstract

BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) is associated with significant impairment in multiple functional domains. This trial evaluated efficacy in ADHD symptoms and functional outcomes in young adults treated with atomoxetine. METHODS: Young adults (18-30 years old) with ADHD were randomized to 12 weeks of double-blind treatment with atomoxetine (n = 220) or placebo (n = 225). The primary efficacy measure of ADHD symptom change was Conners' Adult ADHD Rating Scale (CAARS): Investigator-Rated: Screening Version Total ADHD Symptoms score with adult prompts. Secondary outcomes scales included the Adult ADHD Quality of Life-29, Clinical Global Impression-ADHD-Severity, Patient Global Impression-Improvement, CAARS Self-Report, Behavior Rating Inventory of Executive Function-Adult Version Self-Report, and assessments of depression, anxiety, sleepiness, driving behaviors, social adaptation, and substance use. RESULTS: Atomoxetine was superior to placebo on CAARS: Investigator-Rated: Screening Version (atomoxetine [least-squares mean ± SE, -13.6 ± 0.8] vs placebo [-9.3 ± 0.8], 95% confidence interval [-6.35 to -2.37], P < 0.001), Clinical Global Impression-ADHD-Severity (atomoxetine [-1.1 ± 0.1] vs placebo [-0.7 ± 0.1], 95% confidence interval [-0.63 to -0.24], P < 0.001), and CAARS Self-Report (atomoxetine [-11.9 ± 0.8] vs placebo [-7.8 ± 0.7], 95% confidence interval [-5.94 to -2.15], P < 0.001) but not on Patient Global Impression-Improvement. In addition, atomoxetine was superior to placebo on Adult ADHD Quality of Life-29 and Behavior Rating Inventory of Executive Function-Adult Version Self-Report. Additional assessments failed to detect significant differences (P ≥ 0.05) between atomoxetine and placebo. The adverse event profile was similar to that observed in other atomoxetine studies. Nausea, decreased appetite, insomnia, dry mouth, irritability, dizziness, and dyspepsia were reported significantly more often with atomoxetine than with placebo. CONCLUSIONS: Atomoxetine reduced ADHD symptoms and improved quality of life and executive functioning deficits in young adults compared with placebo. Atomoxetine was also generally well tolerated.

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In a phase 4 study, atomoxetine was observed to reduce ADHD symptoms and improve quality of life in young adults compared with placebo.
“In a phase 4 study that focused on prospectively assessing the efficacy and safety of atomoxetine in young adults, atomoxetine was observed to reduce ADHD symptoms and improve quality of life in young adults compared with placebo [16].”
From Atomoxetine Effects on Executive Function as Measured by the BRIEF-A in Young Adults with ADHD: A Randomized, Double-Blind, Placebo-Controlled Study (2014) · cites this paper as [16]
A potential limitation of the current results is that limited adjustments for multiple comparisons were made, including an overall gatekeeper analysis and Hochberg's p-value adjustment for analysis of BRIEF-A component scores.
“Potential limitations of the current results are that limited adjustments for multiple comparisons were made that included an overall gatekeeper analysis [16] and use of Hochberg’s p-value adjustment for analysis of BRIEF-A component scores.”
From Atomoxetine Effects on Executive Function as Measured by the BRIEF-A in Young Adults with ADHD: A Randomized, Double-Blind, Placebo-Controlled Study (2014) · cites this paper as [16]

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Self-citation

Authors: Durell, T. M., Adler, L. A., Williams, D. W., Deldar, A., McGough, J. J., Glaser, P. E., Rubin, R. L., Pigott, T. A., Sarkis, E. H., & Fox, B. K.
Affiliations: Eli Lilly (United States) (US)
NYU Langone Health (US)
University of California, Los Angeles (US)
University of Kentucky (US)
The University of Texas Health Science Center at Houston (US)
Corresponding author: Durell, Todd M.
Deldar, Ahmed
Sarkis, Elias H.
Fox, Bethany K.
ORCID: Adler, Lenard A.
McGough, James J.
Glaser, Paul E.
Pigott, Teresa A.
Sarkis, Elias H.
Venue: Journal of Clinical Psychopharmacology
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2013-02
Volume: 33
Issue: 1
Pages: 45-54
ISSN: 0271-0749 (ISSN-L)
DOI: 10.1097/jcp.0b013e31827d8a23
OpenAlex: W2155877143
Cited by: 64
References: 36
Citations by year: 2026: 2 · 2025: 1 · 2024: 5 · 2023: 2 · 2022: 4 · 2021: 2 · 2020: 4 · 2019: 2 · 2018: 2 · 2017: 5 · 2016: 8 · 2015: 8 · 2014: 16 · 2013: 3
FWCI: 6.16
Type: journal article
Language: en
Open access: closed
Locations: Journal of Clinical Psychopharmacology (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
Keywords: atomoxetine, attention deficit hyperactivity disorder, young adults, ADHD symptoms, functional outcome, quality of life, executive function, adverse events, depression, anxiety, driver behavior, substance use, social adaptation, sleepiness, irritability, insomnia, nausea, xerostomia, dizziness, dyspepsia, placebo comparison, Conners' Adult ADHD Rating Scale
MeSH terms: Atomoxetine Hydrochloride, Adolescent, Adult, Analysis of Variance, Attention, Attention Deficit Disorder with Hyperactivity, Double-Blind Method, Humans, Predictive Value of Tests, Propylamines, Prospective Studies, Psychiatric Status Rating Scales, Puerto Rico, Quality of Life, Severity of Illness Index, Time Factors, United States, Least-Squares Analysis, Treatment Outcome, Adrenergic Uptake Inhibitors, Recovery of Function, Young Adult, Executive Function

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Atomoxetine Treatment of Attention-Deficit/Hyperactivity Disorder in Young Adults With Assessment of Functional Outcomes: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

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