A randomized, placebo-controlled study of duloxetine for the treatment of children and adolescents with generalized anxiety disorder.

Publisher: Elsevier Country of Publication: United States NLM ID: 8704565 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1527-5418 (Electronic) Linking ISSN: 08908567 NLM ISO Abbreviation: J Am Acad Child Adolesc Psychiatry Subsets: MEDLINE

Publication: Jan. 2010- : New York : Elsevier
Original Publication: [Baltimore, Md.] : The Academy, [1987-

Suicidal Ideation*; Anxiety Disorders/*drug therapy ; Duloxetine Hydrochloride/*administration & dosage ; Selective Serotonin Reuptake Inhibitors/*administration & dosage; Adolescent ; Child ; Dose-Response Relationship, Drug ; Double-Blind Method ; Duloxetine Hydrochloride/adverse effects ; Female ; Humans ; Male ; Mexico ; Psychiatric Status Rating Scales ; Selective Serotonin Reuptake Inhibitors/adverse effects ; Severity of Illness Index ; South Africa ; Treatment Outcome ; United States

Objective: To evaluate the efficacy, safety, and tolerability of the selective serotonin norepinephrine inhibitor duloxetine in children and adolescents with generalized anxiety disorder (GAD).
Method: 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).
Conclusion: 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.
(Copyright © 2015 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.)

Keywords: duloxetine; generalized anxiety disorder; selective serotonin norepinephrine reuptake inhibitor

ClinicalTrials.gov NCT01226511

0 (Serotonin Uptake Inhibitors)
9044SC542W (Duloxetine Hydrochloride)

Date Created: 20150321 Date Completed: 20161215 Latest Revision: 20221207

20231215

10.1016/j.jaac.2015.01.008

25791145