Depressive Disorder, Major
Conditions
Interventions
DRUG: Brenipatide(Other Name: LY3537031)
Administered SC
DRUG: Placebo
Administered SC
(Study Arms)
Experimental: Brenipatide Dose 1
Brenipatide administered subcutaneously (SC) + standard of c
Sponsors
Takeshi Masaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Meet the diagnostic criteria for major depressive disorder - Are on a stable standard of care medication for major depressive disorder - 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 *D23 self-inject study intervention * store and use the provided blinded study intervention, as directed * maintain electronic and paper study diaries, as applicable, and * complete the required questionnaires
Exclusion criteria
Exclusion criteria: - Have a lifetime history or current diagnosis of the following: * schizophrenia or other psychotic disorder * bipolar disorder * borderline personality disorder, or * any eating disorder. - Have type 1 diabetes mellitus, or a history of * ketoacidosis, or * hyperosmolar state or coma. - Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening - Are actively suicidal or deemed a significant risk for suicide - Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Relapse Defined as the Number of Days from Randomization to Date on Which the Participant Meets Any Relapse Criterion of Major Depressive Disorder (MDD) [Time Frame: From Randomization in Double-Blind Adjunctive Treatment to First Relapse For at Least 12 Months] | — |
Countries
Australia, Brazil, Canada, China, Germany, Greece, Japan, Mexico, Poland, Puerto Rico, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactTrial Guide Call Center
Eli Lilly Japan K.K.
Outcome results
None listed