NCT01187407

A Study of Flexible or Fixed Dose LY2216684 as Adjunctive Treatment for Participants With Major Depressive Disorder Who Have Had a Partial Response to Selective Serotonin Reuptake Inhibitor (SSRI) Treatment

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,480 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Following the Confirmation (CF) Phase, participants were randomized to adjunctive LY2216684 or adjunctive placebo if they had \<25% improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score over the past 3 weeks and a current MADRS total score ≥14. Participants who did not meet criteria received adjunctive placebo to preserve the blind.

Conditions

• Major Depressive Disorder (MDD)

Interventions

Type	Name	Description
DRUG	LY2216684
DRUG	Placebo
DRUG	SSRI	Participants should have been on their SSRI for at least 6 weeks prior and were to continue on their stable dose throughout the study

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2010-08-24
• Last updated: 2018-04-24
• Results posted: 2018-04-24

Locations

54 sites across 7 countries: United States, Croatia, Czechia, Finland, Japan, Puerto Rico, Slovakia