A Study of Brenipatide in Adult Participants With Major Depressive Disorder
ConditionDepressive Disorder, Major
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEli Lilly and Company
About this trial
This study evaluates the safety and efficacy of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC in delaying the return of major depressive symptoms.
The trial is divided into three periods as follows: a screening period that will last approximately 1 month, a treatment period that will last a minimum of 12 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if depression symptoms worsen or if withdrawal from the study occurs for any reason.
Eligibility criteria
Qualifiers
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
self-inject study intervention
Disqualifiers
schizophrenia or other psychotic disorder
bipolar disorder
borderline personality disorder, or
any eating disorder.
Trial design
Treatments tested in this trial
- Brenipatide
- Placebo
Treatment groups
1,000 Participants
are divided into 4 treatment groupsLocations
186Australia
Mater Misericordiae Limited4101, Brisbane Australia
NeuroCentrix3053, Carlton Australia
Lyell McEwin Hospital5112, Elizabeth Vale Australia
Barwon Health3220, Geelong Australia
Sponsors and collaborators
Eli Lilly and Company
Lead sponsor
Source ClinicalTrials.gov