To assess the efficacy of atomoxetine (ATX) and impact of treatment on family functioning in adults with ADHD.
Adults with attention-deficit/hyperactivity disorder (ADHD) having both a spouse/partner and child were randomized to placebo (n = 234) or ATX (n = 268) for 24 weeks. Attention-deficit/hyperactivity disorder measures included the Conners Adult ADHD Rating Scale total ADHD Symptoms score and Clinical Global Impression-ADHD—Severity. Marital measures included the Dyadic Adjustment Scale and the Family Assessment Measure Dyadic Relationship Scale (FAM III). Parenting measures included the Parenting Stress Index, Alabama Parenting Questionnaire, and Parenting Sense of Competence Scale (PSCS).
Improvement was greater with ATX over placebo at 24 weeks on the Conners Adult ADHD Rating Scale (−16.43 vs −8.65; P < 0.001, repeated measures) and Clinical Global Impression (P < 0.001, last observation carried forward). Baseline-to-end point changes in marital and parenting measures were significant but not between treatment groups. Post hoc analyses showed significant interaction of treatment and impairment for the FAM III Task Accomplishment (patient) and Role Performance (patient and spouse) items and PSCS efficacy. Further stratification by sex or presence of a child with ADHD yielded significant interaction and treatment differences for the FAM III Task Accomplishment and the FAM III and Dyadic Adjustment Scale affective expression items, PSCS total score, Alabama Parenting Questionnaire Corporal Punishment, and Parenting Stress Index attachment items.
Atomoxetine demonstrated significant ADHD symptom reduction over 24 weeks. Although both groups demonstrated baseline-to-end point changes on many marital and parenting measure items, there were no treatment differences. Maladaptive behaviors of long-standing ADHD may benefit from both medication and behavioral-psychosocial intervention.
*Eli Lilly and Company and/or one of its subsidiaries, Indianapolis, IN; †Rochester Center for Behavioral Medicine, Wayne State University School of Medicine, Detroit, MI; ‡Departments of Psychiatry and Neurology, Indiana University School of Medicine, Indianapolis, IN; §Department of Psychiatry, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, OH; and ∥NeuroScience, Inc, Herndon, VA.
Conflicts of Interest and Source of Funding: Linda Wietecha is an employee and minor shareholder of Eli Lilly and Company and/or one of its subsidiaries. Joel Young is in the speaker’s bureaus of AstraZeneca, Bristol-Meyers Squibb, Eli Lilly and Company, Forest, GlaxoSmithKline, McNeil, Novartis, Schering-Plough, Sepracor, and Shire; has received grants/research support from Cyberonics, Eli Lilly and Company, Novartis, Otsuka, Shire and Takeda; and is in the advisory boards of Eli Lilly and Company, Novartis, Shire, and Shionogi. Dustin Ruff is an employee and minor shareholder of Eli Lilly and Company and/or one of its subsidiaries. David Dunn has received grants/research support from Eli Lilly and Company, GlaxoSmithKline, and Supernus Pharmaceuticals. Robert Findling is in the speaker’s bureaus of Bristol-Meyers Squibb, Johnson & Johnson, and Shire; has received grants/research support from Abbott, Addrenex, AstraZeneca, Bristol-Meyers Squibb, Forest, GlaxoSmithKline, Johnson & Johnson, Eli Lilly and Company, Merck, National Institute of Health, Neuropharm, Novartis, Otsuka, Pfizer, Rhodes Pharmaceuticals, Schering-Plough, Shionogi, Shire, Stanley Medical Research Institute, Supernus Pharmaceuticals, and Wyeth; is a consultant for Abbott, Addrenex, Alexza, AstraZeneca, Biovail, Bristol-Meyers Squibb, Forest, GlaxoSmithKline, Guilford Press, Johnson & Johnson, Eli Lilly and Company, Merck, Noven, Organon, Sanofi-Aventis, Schering-Plough, Seaside Therapeutics, Sepracor, Solvay, Transcept, Validus, and Wyeth. Keith Saylor has received grants/research support from Abbott, AstraZeneca, Bristol-Meyers Squibb, Eli Lilly and Company, Johnson & Johnson, Novartis, Otsuka, Shire, and Supernus Pharmaceuticals; and is in the advisory boards of Otsuka and Supernus Pharmaceuticals.
This trial was funded by Lilly USA, LLC.
Address correspondence and reprint requests to Linda Wietecha, BSN, MS, Lilly USA, LLC, Lilly Corporate Center, Indianapolis, IN 46285; E-mail: email@example.com