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Atomoxetine treatment in children and adolescents with ADHD and comorbid tic disorders

From the Lilly Research Laboratories (Drs. Allen, Feldman, and Kelsey, and D.R. Milton and L.L. Layton), Indianapolis, IN; Department of Neurology (Dr. Kurlan), University of Rochester School of Medicine and Dentistry, NY; Department of Pediatrics (Drs. Gilbert and Sallee), Cincinnati Children’s Hospital Medical Center, OH; New York University Child Study Center (Dr. Coffey), NY; Dallas Pediatric Neurology Associates (Dr. Linder), Dallas, TX; Monarch Research Associates (Dr. Lewis), Norfolk, VA; Premiere Research Institute (Dr. Winner), Palm Beach Neurology, West Palm Beach, FL; Riley Child and Adolescent Psychiatry Clinic (Dr. Dunn), Indianapolis, IN; Department of Pediatrics, Division of Neurology (Dr. Dure), University of Alabama at Birmingham; Bancroft NeuroHealth (Dr. Mintz), Cherry Hill, NJ; Arizona Family Resource Counseling Center (Dr. Ricardi), Phoenix; the Department of Neurology (Dr. Erenberg), Cleveland Clinic Foundation, OH; and the Pediatric Psychopharmacology Unit (Dr. Spencer), Massachusetts General Hospital/Harvard Medical School, Boston.

Address correspondence and reprint requests to Dr. Albert J. Allen, Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285; e-mail: allenaj{at}lilly.com

Objective: To test the hypothesis that atomoxetine does not significantly worsen tic severity relative to placebo in children and adolescents with attention deficit/hyperactivity disorder (ADHD) and comorbid tic disorders.

Methods: Study subjects were 7 to 17 years old, met Diagnostic and Statistical Manual of Mental Disorders–IV criteria for ADHD, and had concurrent Tourette syndrome or chronic motor tic disorder. Patients were randomly assigned to double-blind treatment with placebo (n = 72) or atomoxetine (0.5 to 1.5 mg/kg/day, n = 76) for up to 18 weeks.

Results: Atomoxetine treatment was associated with greater reduction of tic severity at endpoint relative to placebo, approaching significance on the Yale Global Tic Severity Scale total score (–5.5 ± 6.9 vs –3.0 ± 8.7, p = 0.063) and Tic Symptom Self-Report total score (–4.7 ± 6.5 vs –2.9 ± 5.2, p = 0.095) and achieving significance on the Clinical Global Impressions (CGI) tic/neurologic severity scale score (–0.7 ± 1.2 vs –0.1 ± 1.0, p = 0.002). Atomoxetine patients also showed greater improvement on the ADHD Rating Scale total score (–10.9 ± 10.9 vs –4.9 ± 10.3, p < 0.001) and CGI severity of ADHD/psychiatric symptoms scale score (–0.8 ± 1.1 vs –0.3 ± 1.0, p = 0.015). Discontinuation rates were not significantly different between treatment groups. Atomoxetine patients had greater increases in heart rate and decreases of body weight, and rates of treatment-emergent decreased appetite and nausea were higher. No other clinically relevant treatment differences were seen in any other vital sign, adverse event, or electrocardiographic or laboratory measures.

Conclusions: Atomoxetine did not exacerbate tic symptoms. Rather, there was some evidence of reduction in tic severity with a significant reduction of attention deficit/hyperactivity disorder symptoms. Atomoxetine treatment appeared safe and well tolerated.

Disclosure: Sponsored by Eli Lilly and Company. Drs. Allen, Feldman, and Kelsey, D.R. Milton, and L.L. Layton are employees of and shareholders in Eli Lilly and Company. Dr. Gilbert receives research support from the Tourette Syndrome Association, Lilly, NINDS, and NIMH. He does no consulting, advising, or speaker’s bureaus. Dr. Linder currently receives research support from Lilly, Abbott, and Johnson & Johnson. He is on the speaker’s bureau for Lilly, Astra-Zeneca, McNeil, and Valeant. He is not on any advisory boards at this time. Dr. Coffey receives research support from NIMH, NINDS, Tourette Syndrome Association, Bristol Myers Squibb, and Lilly. She is a member on the advisory board and speaker’s bureau for Lilly. Dr. Lewis receives research support from Lilly, Astra-Zeneca, McNeil, and Abbott Labs. Dr. Winner is on the speaker’s bureau for Pfizer, Glaxo, Merck, McNeil, and Astra-Zeneca. He is also on the Advisory Board for Glaxo, Merck, Allergan, McNeil, Astra-Zeneca, and Excel. He also does research with Glaxo, McNeil, and Astra-Zeneca. Dr. Dunn receives research support from Astra-Zeneca, Lilly, and Shire. He is a member of the speaker’s bureau for Lilly, McNeil, and UCB. Dr. Sallee receives research support from Shire, Otsuka, Lilly, and NINDS. He is a member of the speaker’s bureau for Pfizer and Lilly and is on the advisory board of Shire and Pfizer. Dr. Mintz receives research support from UCB Pharma, Lilly, Glaxo, McNeil, and NIH. He is a member of the speaker’s bureau for Lilly and UCB Pharma. Dr. Ricardi is a speaker for Lilly and receives research support from Lilly. Dr. Erenberg is a member of the speaker’s bureau for Lilly, McNeil, Shire, and UCB Pharma. Dr. Spencer receives research support from Shire, Lilly, Janssen, Pfizer, McNeil, Novartis, and NIMH. He is a member of the speaker’s bureau for Lilly, Novartis, Shire, and McNeil. Dr. Spencer is on the advisory boards for Shire, Lilly, McNeil, Novartis, Janssen, and Johnson & Johnson. Drs. Kurlan, Gilbert, Linder, Lewis, Winner, Dunn, Dure, Sallee, Mintz, Ricardi, Erenberg, and Spencer have received grants from Eli Lilly in excess of $10,000.

Received November 19, 2003. Accepted in final form September 13, 2005.

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