A Study in Pediatric Participants With Generalized Anxiety Disorder

Phase 3 Completed 281 enrolled Eli Lilly and Company

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to find out if duloxetine \[30-120 milligrams (mg)\] given once a day by mouth for 10 weeks to children and adolescents, is better than placebo when treating Generalized Anxiety Disorder (GAD).

Timeline

Start: 2011-06
Primary completion: 2013-02
Completion: 2013-06

Outcome

Met primary endpoint

paper duloxetine was superior to placebo on the primary efficacy analysis PMID 25791145 ↗

registry Duloxetine (Acute Treatment) vs Placebo (Acute Treatment); p <0.001; Least squares (LS) mean difference -2.65 NCT01226511 ↗

Publications

Strawn JR, Prakash A, Zhang Q, Pangallo BA, Stroud CE, Cai N, Findling RL. A randomized, placebo-controlled study of duloxetine for the treatment of children and adolescents with generalized anxiety disorder. J Am Acad Child Adolesc Psychiatry. 2015 Apr;54(4):283-93. doi: 10.1016/j.jaac.2015.01.008. Epub 2015 Jan 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Duloxetine	Small molecule	30 mg	Oral
Subject	Duloxetine	Small molecule	120 mg	Oral