Your browser doesn't support javascript.
loading
A randomized, placebo-controlled study of duloxetine for the treatment of children and adolescents with generalized anxiety disorder.
Strawn, Jeffrey R; Prakash, Apurva; Zhang, Qi; Pangallo, Beth A; Stroud, Chad E; Cai, Na; Findling, Robert L.
Afiliação
  • Strawn JR; 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.
  • Prakash A; Eli Lilly and Co., Indianapolis.
  • Zhang Q; Eli Lilly and Co., Indianapolis.
  • Pangallo BA; Eli Lilly and Co., Indianapolis.
  • Stroud CE; Eli Lilly and Co., Indianapolis.
  • Cai N; Eli Lilly and Co., Indianapolis.
  • Findling RL; Johns Hopkins University/Kennedy Krieger Institute, Baltimore, MD.
J Am Acad Child Adolesc Psychiatry ; 54(4): 283-93, 2015 Apr.
Article em En | MEDLINE | ID: mdl-25791145
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.
Assuntos
Palavras-chave

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Transtornos de Ansiedade / Inibidores Seletivos de Recaptação de Serotonina / Ideação Suicida / Cloridrato de Duloxetina Tipo de estudo: Clinical_trials Limite: Adolescent / Child / Female / Humans / Male País/Região como assunto: Africa / Mexico Idioma: En Revista: J Am Acad Child Adolesc Psychiatry Assunto da revista: PEDIATRIA / PSIQUIATRIA Ano de publicação: 2015 Tipo de documento: Article País de publicação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Transtornos de Ansiedade / Inibidores Seletivos de Recaptação de Serotonina / Ideação Suicida / Cloridrato de Duloxetina Tipo de estudo: Clinical_trials Limite: Adolescent / Child / Female / Humans / Male País/Região como assunto: Africa / Mexico Idioma: En Revista: J Am Acad Child Adolesc Psychiatry Assunto da revista: PEDIATRIA / PSIQUIATRIA Ano de publicação: 2015 Tipo de documento: Article País de publicação: Estados Unidos