CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 281 enrolled
Drug / intervention
Duloxetine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01226511
NCT01226511Phase 3Completed
CompareCT.gov

A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Generalized Anxiety Disorder

Eli Lilly and Company·interventional·Posted Oct 22, 2010·Updated Mar 5, 2014

In Brief

A Phase 3 clinical trial evaluating Duloxetine and Placebo for Anxiety Neuroses and 2 related conditions. Completed, enrolled 281 participants across 24 sites in 3 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnxiety Neuroses, Anxiety States, Neurotic, Neuroses, Anxiety
CountriesMexico, South Africa, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 22, 2010
Enrollment StartJun 1, 2011
Primary CompletionFeb 1, 2013
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 15.7 years ago

Interventions

Duloxetinedrug

Administered orally

Placebodrug

Administered orally