title: A randomized, placebo-controlled study of duloxetine for the treatment of children and adolescents with generalized anxiety disorder.
abstract: OBJECTIVE
  To evaluate the efficacy, safety, and tolerability of the selective serotonin norepinephrine inhibitor duloxetine in children and adolescents with generalized anxiety disorder (GAD).
  
  
  METHODS
  Youth aged 7 through 17 years with a primary diagnosis of GAD were treated with flexibly dosed duloxetine (30-120 mg daily, n = 135) or placebo (n = 137) for 10 weeks, followed by open-label duloxetine (30-120mg daily) for 18 weeks. Efficacy measures included the Pediatric Anxiety Rating Scale (PARS), Clinical Global Impression-Severity (CGI-Severity) scale, and Children's Global Assessment Scale (CGAS). Safety measures included the Columbia-Suicide Severity Rating Scale (C-SSRS) as well as vital signs and electrocardiographic and laboratory monitoring.
  
  
  RESULTS
  On the primary efficacy measure (PARS severity for GAD), mean improvement from baseline to 10 weeks was statistically significantly greater for duloxetine (-9.7) compared with placebo (-7.1, p ≤ .001, Cohen's d: 0.5). Symptomatic response (50% improvement on the PARS severity for GAD), remission (PARS severity for GAD ≤8), and functional remission (CGAS >70) rates for the duloxetine group (59%, 50%, 37%, respectively) were statistically significantly greater than for the placebo group (42%, 34%, 24%, respectively, p ≤ .05) during acute treatment. Changes in systolic and diastolic blood pressure and discontinuation because of adverse events did not statistically differ between the duloxetine and placebo groups, although gastrointestinal-related adverse events, oropharyngeal pain, dizziness, cough, and palpitations were reported with a statistically significantly greater incidence for the duloxetine group compared with the placebo group. Mean changes in pulse and weight for the duloxetine group (+6.5 beats/min, -0.1 kg, respectively) were statistically different from the placebo group (+2.0 beats/min, +1.1 kg, respectively, p ≤ .01).
  
  
  CONCLUSIONS
  In this study, duloxetine was superior to placebo on the primary efficacy analysis of mean change from baseline to week 10 on the PARS severity for GAD score, and safety results were consistent with the known safety profile of duloxetine in pediatric and adult patients. Clinical trial registration information-A Study in Pediatric Participants With Generalized Anxiety Disorder; http://clinicaltrials.gov; NCT01226511.
authors: University of Cincinnati, College of Medicine, and Cincinnati Children's Hospital Medical Center, Division of Child and Adolescent Psychiatry, Cincinnati. Electronic address: strawnjr@uc.edu.
authors: Jeffrey R
authors: JR
authors: Strawn
authors: Eli Lilly and Co., Indianapolis.
authors: Apurva
authors: A
authors: Prakash
authors: Eli Lilly and Co., Indianapolis.
authors: Qi
authors: Q
authors: Zhang
authors: Eli Lilly and Co., Indianapolis.
authors: Beth A
authors: BA
authors: Pangallo
authors: Eli Lilly and Co., Indianapolis.
authors: Chad E
authors: CE
authors: Stroud
authors: Eli Lilly and Co., Indianapolis.
authors: Na
authors: N
authors: Cai
authors: Johns Hopkins University/Kennedy Krieger Institute, Baltimore, MD.
authors: Robert L
authors: RL
authors: Findling
mesh_terms: D000293:Adolescent; D001008:Anxiety Disorders / Q000188:drug therapy*; D002648:Child; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D000068736:Duloxetine Hydrochloride / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008800:Mexico; D011569:Psychiatric Status Rating Scales; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D012720:Severity of Illness Index; D013019:South Africa; D059020:Suicidal Ideation; D016896:Treatment Outcome; D014481:United States
chemical_list: D000068736:Duloxetine Hydrochloride; D017367:Selective Serotonin Reuptake Inhibitors
keywords: duloxetine; generalized anxiety disorder; selective serotonin norepinephrine reuptake inhibitor