drugset / Trial / NCT03315793

A Study of Duloxetine (LY248686) in Japanese Children and Adolescents With Depressive Disorder

NCT03315793 ↗

Phase 3 Completed 149 enrolled Shionogi Eli Lilly and Company · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine the efficacy of duloxetine hydrochloride versus placebo in the treatment of Japanese children and adolescents with depressive disorder.

Timeline

Start
2017-12-04
Primary completion
2019-11-08
Completion
2019-11-08

Outcome

Missed primary endpoint

registry analysis (superiority test); Duloxetine vs Placebo; p = 0.5587; Least squares mean difference 1.39 (98% CI -3.30 to 6.08); mixed-effects model repeated measures NCT03315793 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Duloxetine Small molecule — Oral

Indications