CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 608 enrolled
Drug / intervention
LY2216684 (edivoxetine) +1 moredrug
Likely dose
LY2216684 (edivoxetine) 18 milligramsfrom 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/NCT01155661
NCT01155661Phase 3Completed

Long-Term, Open-Label, Safety Study of LY2216684 12 to 18 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 Jul 2, 2010·Updated Apr 17, 2018

In Brief

A Phase 3 clinical trial evaluating LY2216684 (edivoxetine) and SSRI for Depressive Disorder, Major. Completed, enrolled 608 participants across 48 sites in 7 countries.

Detailed Summary

The primary objective of this study is to evaluate the long-term safety and tolerability of LY2216684 administered once daily (QD) in the adjunctive treatment with a selective serotonin reuptake inhibitor (SSRI) for up to approximately 1 year in participants with major depressive disorder (MDD) who are partial responders to their SSRI treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil, Chile, Lithuania, Mexico, Netherlands, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2, 2010
Enrollment StartOct 1, 2010
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 16 years ago

Interventions

LY2216684 (edivoxetine)drug

12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)

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.