title: Atomoxetine treatment for pediatric patients with attention-deficit/hyperactivity disorder with comorbid anxiety disorder.
abstract: OBJECTIVE
  Research suggests 25% to 35% of children with attention-deficit/hyperactivity disorder (ADHD) have comorbid anxiety disorders. This double-blind study compared atomoxetine with placebo for treating pediatric ADHD with comorbid anxiety, as measured by the ADHD Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-PI) and the Pediatric Anxiety Rating Scale (PARS).
  
  
  METHODS
  Patients (ages 8-17 years) meeting DSM-IV criteria for ADHD and generalized anxiety disorder, separation anxiety disorder, and/or social phobia were randomized to 12 weeks of atomoxetine (n = 87) or placebo (n = 89). ADHDRS-IV-PI and PARS total scores were analyzed using analysis of covariance last observation carried forward and repeated-measures analyses.
  
  
  RESULTS
  Sixty-six patients in each group completed the study. Mean ADHDRS-IV-PI total score improved significantly for atomoxetine (n = 55; -10.5, SD 10.6) relative to placebo (n = 58; -1.4, SD 8.3; p < .001). Mean PARS total score also improved significantly for atomoxetine (n = 55; -5.5, SD 4.8) relative to placebo (n = 58; -3.2, SD 5.0; p = .011).
  
  
  CONCLUSIONS
  Atomoxetine was efficacious in reducing ADHD symptoms in patients who have ADHD with comorbid anxiety and was well tolerated. There was also a significant reduction in independently assessed anxiety symptoms using both clinician-rated and self-rated measures, which merits further investigation. Results support consideration of atomoxetine for the treatment of ADHD in youths who have ADHD with comorbid anxiety disorder.
  
  
  BACKGROUND
  The LYBP study, on which this article is based, was not registered at clinicaltrials.gov because the last patient visit occurred before July 1, 2005. Results, however, are publicly posted at lillytrials.com and clinicalstudyresults.org. The unique study ID at both sites is 6477a.
authors: Dr. Geller is with the Pediatric Psychopharmacology Research Program, Massachusetts General Hospital, Cambridge; Dr. Donnelly is with the Department of Psychiatry, Dartmouth Hitchcock Medical Center, Lebanon, NH; Dr. Lopez is with Children's Developmental C enter, Maitland, FL; Dr. Rubin is with University of Vermont College of Medicine, Burlington; Dr. Newcorn is with the Department of Psychiatry, Mount Sinai School of Medicine, New York; Drs. Sutton, Bakken, Kelsey, and Sumner and Mr. Paczkowski are with the Lilly Research Laboratories, Indianapolis.. Electronic address: dageller@partners.org.
authors: Daniel
authors: D
authors: Geller
authors: Dr. Geller is with the Pediatric Psychopharmacology Research Program, Massachusetts General Hospital, Cambridge; Dr. Donnelly is with the Department of Psychiatry, Dartmouth Hitchcock Medical Center, Lebanon, NH; Dr. Lopez is with Children's Developmental C enter, Maitland, FL; Dr. Rubin is with University of Vermont College of Medicine, Burlington; Dr. Newcorn is with the Department of Psychiatry, Mount Sinai School of Medicine, New York; Drs. Sutton, Bakken, Kelsey, and Sumner and Mr. Paczkowski are with the Lilly Research Laboratories, Indianapolis.
authors: Craig
authors: C
authors: Donnelly
authors: Dr. Geller is with the Pediatric Psychopharmacology Research Program, Massachusetts General Hospital, Cambridge; Dr. Donnelly is with the Department of Psychiatry, Dartmouth Hitchcock Medical Center, Lebanon, NH; Dr. Lopez is with Children's Developmental C enter, Maitland, FL; Dr. Rubin is with University of Vermont College of Medicine, Burlington; Dr. Newcorn is with the Department of Psychiatry, Mount Sinai School of Medicine, New York; Drs. Sutton, Bakken, Kelsey, and Sumner and Mr. Paczkowski are with the Lilly Research Laboratories, Indianapolis.
authors: Frank
authors: F
authors: Lopez
authors: Dr. Geller is with the Pediatric Psychopharmacology Research Program, Massachusetts General Hospital, Cambridge; Dr. Donnelly is with the Department of Psychiatry, Dartmouth Hitchcock Medical Center, Lebanon, NH; Dr. Lopez is with Children's Developmental C enter, Maitland, FL; Dr. Rubin is with University of Vermont College of Medicine, Burlington; Dr. Newcorn is with the Department of Psychiatry, Mount Sinai School of Medicine, New York; Drs. Sutton, Bakken, Kelsey, and Sumner and Mr. Paczkowski are with the Lilly Research Laboratories, Indianapolis.
authors: Richard
authors: R
authors: Rubin
authors: Dr. Geller is with the Pediatric Psychopharmacology Research Program, Massachusetts General Hospital, Cambridge; Dr. Donnelly is with the Department of Psychiatry, Dartmouth Hitchcock Medical Center, Lebanon, NH; Dr. Lopez is with Children's Developmental C enter, Maitland, FL; Dr. Rubin is with University of Vermont College of Medicine, Burlington; Dr. Newcorn is with the Department of Psychiatry, Mount Sinai School of Medicine, New York; Drs. Sutton, Bakken, Kelsey, and Sumner and Mr. Paczkowski are with the Lilly Research Laboratories, Indianapolis.
authors: Jeffrey
authors: J
authors: Newcorn
authors: Dr. Geller is with the Pediatric Psychopharmacology Research Program, Massachusetts General Hospital, Cambridge; Dr. Donnelly is with the Department of Psychiatry, Dartmouth Hitchcock Medical Center, Lebanon, NH; Dr. Lopez is with Children's Developmental C enter, Maitland, FL; Dr. Rubin is with University of Vermont College of Medicine, Burlington; Dr. Newcorn is with the Department of Psychiatry, Mount Sinai School of Medicine, New York; Drs. Sutton, Bakken, Kelsey, and Sumner and Mr. Paczkowski are with the Lilly Research Laboratories, Indianapolis.
authors: Virginia
authors: V
authors: Sutton
authors: Dr. Geller is with the Pediatric Psychopharmacology Research Program, Massachusetts General Hospital, Cambridge; Dr. Donnelly is with the Department of Psychiatry, Dartmouth Hitchcock Medical Center, Lebanon, NH; Dr. Lopez is with Children's Developmental C enter, Maitland, FL; Dr. Rubin is with University of Vermont College of Medicine, Burlington; Dr. Newcorn is with the Department of Psychiatry, Mount Sinai School of Medicine, New York; Drs. Sutton, Bakken, Kelsey, and Sumner and Mr. Paczkowski are with the Lilly Research Laboratories, Indianapolis.
authors: Rosalie
authors: R
authors: Bakken
authors: Dr. Geller is with the Pediatric Psychopharmacology Research Program, Massachusetts General Hospital, Cambridge; Dr. Donnelly is with the Department of Psychiatry, Dartmouth Hitchcock Medical Center, Lebanon, NH; Dr. Lopez is with Children's Developmental C enter, Maitland, FL; Dr. Rubin is with University of Vermont College of Medicine, Burlington; Dr. Newcorn is with the Department of Psychiatry, Mount Sinai School of Medicine, New York; Drs. Sutton, Bakken, Kelsey, and Sumner and Mr. Paczkowski are with the Lilly Research Laboratories, Indianapolis.
authors: Martin
authors: M
authors: Paczkowski
authors: Dr. Geller is with the Pediatric Psychopharmacology Research Program, Massachusetts General Hospital, Cambridge; Dr. Donnelly is with the Department of Psychiatry, Dartmouth Hitchcock Medical Center, Lebanon, NH; Dr. Lopez is with Children's Developmental C enter, Maitland, FL; Dr. Rubin is with University of Vermont College of Medicine, Burlington; Dr. Newcorn is with the Department of Psychiatry, Mount Sinai School of Medicine, New York; Drs. Sutton, Bakken, Kelsey, and Sumner and Mr. Paczkowski are with the Lilly Research Laboratories, Indianapolis.
authors: Douglas
authors: D
authors: Kelsey
authors: Dr. Geller is with the Pediatric Psychopharmacology Research Program, Massachusetts General Hospital, Cambridge; Dr. Donnelly is with the Department of Psychiatry, Dartmouth Hitchcock Medical Center, Lebanon, NH; Dr. Lopez is with Children's Developmental C enter, Maitland, FL; Dr. Rubin is with University of Vermont College of Medicine, Burlington; Dr. Newcorn is with the Department of Psychiatry, Mount Sinai School of Medicine, New York; Drs. Sutton, Bakken, Kelsey, and Sumner and Mr. Paczkowski are with the Lilly Research Laboratories, Indianapolis.
authors: Calvin
authors: C
authors: Sumner
mesh_terms: D018759:Adrenergic Uptake Inhibitors / Q000627:therapeutic use*; D001008:Anxiety Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology*; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology*; D002648:Child; D015897:Comorbidity; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D011437:Propylamines / Q000627:therapeutic use*
chemical_list: D018759:Adrenergic Uptake Inhibitors; D011437:Propylamines; D000069445:Atomoxetine Hydrochloride