Atomoxetine treatment for pediatric patients with attention-deficit/hyperactivity disorder with comorbid anxiety disorder.
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.
Geller
Daniel
D
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.
Donnelly
Craig
C
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.
Lopez
Frank
F
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.
Rubin
Richard
R
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.
Newcorn
Jeffrey
J
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.
Sutton
Virginia
V
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.
Bakken
Rosalie
R
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.
Paczkowski
Martin
M
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.
Kelsey
Douglas
D
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.
Sumner
Calvin
C
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.
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*
D018759:Adrenergic Uptake Inhibitors; D011437:Propylamines; D000069445:Atomoxetine Hydrochloride