CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,056 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/NCT01185340
NCT01185340Phase 3Completed

A Randomized Placebo-Controlled, Double-Blind Study of LY2216684 Flexible-Dose 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 Aug 19, 2010·Updated Apr 27, 2018

In Brief

A Phase 3 clinical trial evaluating LY2216684, Placebo, and 1 other intervention for Major Depressive Disorder. Completed, enrolled 1,056 participants across 49 sites in 7 countries.

Detailed Summary

The primary objective of this study is to assess whether LY2216684 12 milligrams (mg) or 18 mg flexible dose once daily is superior to placebo once daily in the adjunctive treatment of participants with major depressive disorder (MDD) who are partial responders to their selective serotonin reuptake inhibitor (SSRI) treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Belgium, Germany, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 19, 2010
Enrollment StartMar 1, 2011
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.1 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