{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T20:09:24Z","timestamp":1777493364988,"version":"3.51.4"},"reference-count":42,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2011,4,1]],"date-time":"2011-04-01T00:00:00Z","timestamp":1301616000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Child and Adolescent Psychopharmacology"],"published-print":{"date-parts":[[2011,4]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>The primary objective of this study was to evaluate the efficacy of atomoxetine (ATX, target dose 1.2\u2009mg\/kg daily) on symptoms of oppositional defiant disorder (ODD) in children and adolescents with attention-deficit\/hyperactivity disorder (ADHD). A secondary objective was to compare fast versus slow up-titration of ATX.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>\n                      This was a 3-arm, 9-week, randomized, placebo-controlled, double-blind study in ADHD patients (6\u201317 years) with comorbid ODD (\n                      <jats:italic toggle=\"yes\">Diagnostic and Statistical Manual of Mental Disorders<\/jats:italic>\n                      , 4th edition [DSM-IV] criteria A\u2013C) or conduct disorder (CD). ATX-treatment arms were as follows\u2014ATX-fast: 7 days 0.5\u2009mg\/kg, then 1.2\u2009mg\/kg; ATX-slow: 7 days each at 0.5 and 0.8\u2009mg\/kg, then 1.2\u2009mg\/kg. Primary outcome was the Swanson, Nolan, and Pelham Rating Scale-Revised (SNAP-IV) ODD-score after 9 weeks (Mixed Effects Model for Repeated Measures, ATX-up-titration groups pooled).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      In total, 181 patients were randomized, and 180 evaluated (ATX-fast\/ATX-slow\/placebo: 60\/61\/59). Baseline characteristics were comparable (84.4% boys; mean age 11.0 years; DSM-IV: 100% ADHD, 75.6% with combined type, 74.4% ODD, 24.4% CD; SNAP-IV ODD-scores, mean\u2009\u00b1\u2009standard deviation 15.5\u2009\u00b1\u20094.35). At week 9, SNAP-IV ODD scores were significantly lower versus placebo in both ATX-groups (least square mean [95% confidence interval]: ATX-fast 8.6 [7.2;9.9]; ATX-slow 9.0 [7.7;10.3]; placebo 12.0 [10.6;13.5]; least square mean, ATX-pooled minus placebo: \u22123.2 [\u22125.0, \u22121.5], effect size: \u22120.69,\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009&lt;\u20090.001). SNAP-IV ADHD-scores, CD symptoms (investigator-rated Attention-Deficit and Disruptive Behavior Disorders Instrument, disruptive behavior), Clinical Global Impressions-Severity, and individual treatment behaviors showed corresponding results.\n                      <jats:italic toggle=\"yes\">Post-hoc<\/jats:italic>\n                      analyses indicated interrelationships between the medication effects on ADHD, ODD, and CD symptom scores. For ATX-slow, time to early dropout was significantly longer versus placebo (Hazard Ratio [95% confidence interval]: 3.57 [1.42;8.94];\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009=\u20090.007). Clinically relevant adverse effects (fatigue, sleep disorders, nausea, and gastrointestinal complaints; weeks 1\u20133) were reported in 60.0% of ATX-fast, 44.3% of ATX-slow, and 18.6% of placebo group patients.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>ATX for 9 weeks significantly reduced symptoms of ODD\/CD and ADHD; slower ATX-up-titration may be better tolerated.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/cap.2009.0111","type":"journal-article","created":{"date-parts":[[2011,4,13]],"date-time":"2011-04-13T16:15:37Z","timestamp":1302711337000},"page":"97-110","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":39,"title":["Atomoxetine Versus Placebo in Children and Adolescents with Attention-Deficit\/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder: A Double-Blind, Randomized, Multicenter Trial in Germany"],"prefix":"10.1177","volume":"21","author":[{"given":"Ralf W.","family":"Dittmann","sequence":"first","affiliation":[{"name":"Central Institute of Mental Health","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexander","family":"Schacht","sequence":"additional","affiliation":[{"name":"Lilly Deutschland GmbH","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karin","family":"Helsberg","sequence":"additional","affiliation":[{"name":"Lilly Deutschland GmbH","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian","family":"Schneider-Fresenius","sequence":"additional","affiliation":[{"name":"Lilly Deutschland GmbH","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin","family":"Lehmann","sequence":"additional","affiliation":[{"name":"Lilly Deutschland GmbH","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gerd","family":"Lehmkuhl","sequence":"additional","affiliation":[{"name":"University of Cologne","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter M.","family":"Wehmeier","sequence":"additional","affiliation":[{"name":"Lilly Deutschland GmbH","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2011,4,1]]},"reference":[{"key":"e_1_3_3_2_1","volume-title":"Text Revision (DSM-IV-TR)","author":"American Psychiatric Association","year":"2000","unstructured":"American Psychiatric Association. 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