A Phase 2, Multicenter, Randomized, Double-blind, Parallel-arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide Compared With Placebo in Adult Participants With Major Depressive Disorder Who Have Partial Response to Antidepressant Therapy (RENEW-MDD-3)

Eli Lilly and Company

Summary

This study evaluates the safety and efficacy of brenipatide (LY3537031) as an add on therapy in participants with major depression who still have symptoms while taking a stable dose of standard of care anti-depressant medicine. The study will last approximately 5 months.

Eligibility

Age range: 18–75 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Have a diagnosis of Major Depressive Disorder (MDD) and are in a current major depressive episode, without psychotic features * Are on a stable antidepressant monotherapy regimen for the current major depressive episode * Are a partial responder to the current antidepressant monotherapy regimen * Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as: * self-inject study intervention * store and use the provided blinded study interv…

Locations (75)

IMA Clinical Research - Phoenix
Phoenix, Arizona
Inland Psychiatric Medical Group
Chino, California
Catalina Research Institute, LLC
Montclair, California
Excell Research
Oceanside, California
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California
Alliance Clinical West Hills
West Hills, California

Summary

Eligibility

Interventions

Locations (75)