NCT01155661

A Safety Study in Participants With Major Depressive Disorder

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 608 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	LY2216684 (edivoxetine)	12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
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: 2010-10-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-07-02
• Last updated: 2018-04-17
• Results posted: 2018-04-17

Locations

48 sites across 7 countries: United States, Brazil, Chile, Lithuania, Mexico, Netherlands, Spain