drugset / Trial / NCT01299272

A Study in Prevention of Re-emergence of Depression Symptoms

NCT01299272

Phase 3 Completed 1249 enrolled Eli Lilly and Company
RandomizedParallel-groupTriple-blindTreatment

Summary

The primary objective of this study was to assess the maintenance of efficacy of LY2216684 compared with placebo as adjunctive therapy to selective serotonin reuptake inhibitors (SSRIs) as measured by the time-to-symptom reemergence among participants with major depressive disorder (MDD) who met randomization criteria with adjunctive LY2216684 during the stabilization period. This trial consists of two distinct periods: an open-label treatment period, which consists of two parts, 8 weeks acute open-label with movement to 12 weeks open-label stabilization if participants are in remission at end of 8 weeks (open-label for 20 weeks total) followed by a randomized, double-blind, placebo-controlled period for 24 weeks.

Timeline

Start
2011-05
Primary completion
2013-11
Completion
2013-11

Drugs

EvaluationDrugModalityDoseRoute
Subject edivoxetine Small molecule 12 mg Oral
Subject edivoxetine Small molecule 18 mg Oral