NCT00840034

A Study of Adjunctive Treatment to Antidepressant Therapy for Adults With Major Depressive Disorder

A Study of Augmentation With LY2216684 for Patients With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 227 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose is to study the efficacy, safety, and tolerability of LY2216684 as an adjunctive treatment for 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) (as defined by history).

Detailed description

This is a 12 week multi-center, double-blind, placebo-controlled study on the efficacy of LY2216684 augmentation of selective serotonin reuptake inhibitors (SSRIs) in participants with MDD who have a partial response to treatment with an SSRI. While remaining on a steady dose of their SSRI treatment at entry into the study, participants will be randomly assigned to adjunctive treatment with LY2216684 or placebo in a 1:1 ratio for 10 weeks of acute treatment.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	LY2216684	Starting dose is 6 milligrams (mg), then titrate up to 9 mg, 12 mg, or 18 mg (3 tablets) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2 week taper.
DRUG	Placebo	3 tablets PO QD for up to 12 weeks

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2009-02-10
• Last updated: 2018-04-24
• Results posted: 2018-04-24

Locations

24 sites across 1 country: United States