CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,480 enrolled
Drug / intervention
LY2216684 +2 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/NCT01187407
NCT01187407Phase 3Completed

A Randomized, Placebo-Controlled, Double-Blind Study of LY2216684 Flexible-Dose 12 mg to 18 mg Once Daily and LY2216684 Fixed-Dose 6 mg Once Daily as Adjunctive Treatment for Patients With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment

Eli Lilly and Company·interventional·Posted Aug 24, 2010·Updated Apr 24, 2018

In Brief

A Phase 3 clinical trial evaluating LY2216684, Placebo, and 1 other intervention for Major Depressive Disorder (MDD). Completed, enrolled 1,480 participants across 54 sites in 7 countries.

Detailed Summary

The purpose of this study is to assess if LY2216684 (flexible dose of 12 to 18 milligrams \[mg\] or fixed dose of 6 mg once daily) is superior to placebo once daily in the adjunctive treatment of participants with Major Depressive Disorder (MDD) who were identified as partial responders to an adequate course of treatment with a selective serotonin reuptake inhibitor (SSRI) during an 8-week, double-blind, acute adjunctive treatment phase.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCroatia, Czechia, Finland, Japan, Puerto Rico, Slovakia, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 24, 2010
Enrollment StartMar 1, 2011
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 15.9 years ago

Interventions

LY2216684drug

Placebodrug

SSRIdrug

Participants should have been on their SSRI for at least 6 weeks prior and were to continue on their stable dose throughout the study