Atomoxetine in children with attention-deficit hyperactivity disorder with prior stimulant therapy: a prospective open-label study (original) (raw)

Abstract

The objective of the study is to evaluate the effectiveness and tolerability of atomoxetine in youth, ages 6–17 years with ADHD, who had a prior trial of stimulant treatment. This was a 6-week prospective open-label study of atomoxetine, dosage up to 1.4 mg/kg per day in 34 children and adolescents with DSM-IV ADHD. Primary measures of response included the ADHD Rating Scale (ADHD RS) and the Clinical Global Impression (CGI) Scale. Analyses were intention-to-treat. The treatment with atomoxetine was associated with statistical and clinical significant reduction in clinician rated ADHD RS symptoms, compared with baseline. Statistical significant improvement was attained by the second week of treatment. Fifty-six percent (N = 18) met criteria for our a priori definition of response; much or very much improved on the CGI plus more than 30% reduction in ADHD RS symptoms. In conclusion, atomoxetine was generally well tolerated; 85% of subjects completed the trial. Atomoxetine was effective and well tolerated in a 6-week open study of ADHD youth with a prior history of stimulant treatment.

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Acknowledgments

This study was an investigator initiated project funded by Eli Lilly and Company (with principal investigator Joseph Biederman, MD). Also, special thanks to the Pediatric Psychopharmacology Council Fund for its contributions.

Conflicts of interest statement

Dr. Hammerness has been a speaker for, received research funds or participated in CME activities/professional talks supported by the following pharmaceutical companies: Abbott, Eli Lilly & Company, Forest Research Institute, Ortho-McNeil-Janssen, and Shire. Dr. Hammerness has also received research funds from Elminda Ltd. Dr. Hammerness has also participated, as an investigator, in research studies in the past 2 years funded by the following pharmaceutical companies: Bristol Myers Squibb, Cephalon, Eli Lilly, Johnson & Johnson, McNeil, New River, Novartis, Organon, Otsuka, Pfizer, Shire, Takeda. Dr. Eric Mick is on the advisory board for Shire and Novartis. Dr. Eric Mick is/was on the speakers bureau for Novartis, Shire, McNeil, Janssen, Neuroeducational Institute, CME Outfitters, Danemiller Foundation, Physicians Academy for Clinical and Management Excellence. Dr. Eric Mick received publication honoraria from Novartis. Dr. Robert Doyle is on the advisory board for Novartis and Shire. Dr. Robert Doyle is on the Speakers Bureau for Novartis, Shire, McNeil, Janssen, Neuroeducational Institute, CME Outfitters, Danemiller Foundation, Physicians Academy for Clinical and Management Excellence. Dr. Robert Doyle received Publication Honoraria from Novartis. Ms. Meghan Kotarski has nothing to disclose. Dr. Anna Georgiopoulos gave a CME presentation in 2009, Pri-Med, supported by educational grant from McNeil Pediatrics, administered by Ortho-McNeil Janssen Scientific Affairs. Dr. Anna Georgiopoulos received an unrestricted educational grant for book project, GlaxoSmithKline in 2005. Dr. Gagan Joshi is a subinvestigator for clinical trials sponsored by Shire, Johnson & Johnson, Pfizer, Merck, Cephlon, McNeil, Eli-Lily, Abbott, Novartis, Bristol Myers Squibb, Organon, Otsuka, Takeda, & New River Pharmaceuticals. Dr. Gagan Joshi is a site PI for a multi-centered trial for Glaxo Smith Kline. Dr. Gagan Joshi is a site PI for a multi-centered trial for Bristol Myers Squibb. Dr. Gagan Joshi is CME sponsored by SynerMed Communications for McNeil Pediatrics. Dr. Gagan Joshi received the Pilot Research Award from the American Academy of Child and Adolescent Psychiatry 2005. Dr. Gagan Joshi received the Ethel DuPont Warren Fellowship Award 2005–2006. Ms. Sarah Zeitlin has nothing to disclose. Dr. Joseph Biederman is currently receiving research support from the following sources: Alza, AstraZeneca, Bristol Myers Squibb, Eli Lilly and Co., Janssen Pharmaceuticals Inc., McNeil, Merck, Organon, Otsuka, Shire, NIMH, and NICHD. In previous years, Dr. Joseph Biederman received research support, consultation fees, or speaker’s fees for/from the following additional sources: Abbott, AstraZeneca, Celltech, Cephalon, Eli Lilly and Co., Esai, Forest, Glaxo, Gliatech, Janssen, McNeil, NARSAD, NIDA, New River, Novartis, Noven, Neurosearch, Pfizer, Pharmacia, The Prechter Foundation, Shire, The Stanley Foundation, UCB Pharma, Inc. and Wyeth.

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Authors and Affiliations

  1. Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA
    Paul Hammerness, Robert Doyle, Meghan Kotarski, Anna Georgiopoulos, Gagan Joshi, Sarah Zeitlin & Joseph Biederman
  2. 185 Alewife Brook Parkway, Suite 2000, Cambridge, MA, 02138, USA
    Paul Hammerness

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  1. Paul Hammerness
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  2. Robert Doyle
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  3. Meghan Kotarski
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  4. Anna Georgiopoulos
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  5. Gagan Joshi
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  6. Sarah Zeitlin
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  7. Joseph Biederman
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Correspondence toPaul Hammerness.

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Hammerness, P., Doyle, R., Kotarski, M. et al. Atomoxetine in children with attention-deficit hyperactivity disorder with prior stimulant therapy: a prospective open-label study.Eur Child Adolesc Psychiatry 18, 493–498 (2009). https://doi.org/10.1007/s00787-009-0017-8

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