A Study of Brenipatide in Adult Participants With Major Depressive Disorder
Recruiting · NCT07412756 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
BrenipatidePlacebo
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
- 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
- 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
Where it is running
60 locations listed across 19 US states.
- Accellacare - Moorpark - Moorpark, California, United States
- ATP Clinical Research - Orange, California, United States
- Yale University School of Medicine - New Haven, Connecticut, United States
- Encore Medical Research - Hollywood, Florida, United States
- K2 Medical Research - Maitland - Maitland, Florida, United States
- Life Medical Research Group Corp - Miami Gardens, Florida, United States
- Floridian Clinical Research, LLC - Miami Lakes, Florida, United States
- CLA Research - Naples, Florida, United States
- Optimal Research Sites - Orange City, Florida, United States
- Charter Research - Orlando - Orlando, Florida, United States
- K2 Medical Research - Tampa - Tampa, Florida, United States
- CenExel iResearch, LLC - Decatur, Georgia, United States
- Indiana University Health Neuroscience Center - Indianapolis, Indiana, United States
- Cedar Valley Medical Specialists - Waterloo, Iowa, United States
- Pharmasite Research, Inc. - Baltimore, Maryland, United States
- Adams Clinical Boston - Boston, Massachusetts, United States
- K2 Medical Research - Foxborough - Foxborough, Massachusetts, United States
- Adams Clinical Watertown - Watertown, Massachusetts, United States
- Arcturus Healthcare , PLC, Troy Internal Medicine Research Division - Troy, Michigan, United States
- Arch Clinical Trials - St Louis, Missouri, United States
- Vector Clinical Trials - Las Vegas, Nevada, United States
- Adams Clinical Harlem - New York, New York, United States
- Summit Headlands - Portland, Oregon, United States
- Suburban Research Associates - Media, Pennsylvania, United States
- Penn Medicine: University of Pennsylvania Health System - Philadelphia, Pennsylvania, United States
- Circle Clinical Research - Sioux Falls, South Dakota, United States
- Adams Clinical Dallas - DeSoto, Texas, United States
- Re:Cognition Health - Fort Worth - Fort Worth, Texas, United States
- Consano Clinical Research, LLC - Shavano Park, Texas, United States
- Alpine Research Organization - Clinton, Utah, United States
- Re:Cognition Health - Fairfax, Virginia, United States
- Northwest Clinical Research Center - Bellevue, Washington, United States
- Universitätsklinikum Aachen - Aachen, Germany
- Korea University Ansan Hospital - Ansan-si, South Korea
- Abe Clinic - Arakawa - Arakawa City, Japan
- Argolida General Hospital - Argos, Greece
- Aiginiteio University Hospital - Athens, Greece
- Multidisciplinary Mental Health Hospital of Attiki - Athens, Greece
- Parc de Salut Mar - Hospital del Mar - Barcelona, Spain
- Institucion Hosp Hestia Palau - Barcelona, Spain
- Hospital Universitari Vall d'Hebron - Barcelona, Spain
- Hospital Clínic de Barcelona - Barcelona, Spain
- Hospital de la Santa Creu i Sant Pau - Barcelona, Spain
- SCB Research Center - Bayamón, Puerto Rico
- Beijing Anding Hospital - Affiliated Capital University of Medical Science - Beijing, China
- Beijing HuiLongGuan Hospital - Beijing, China
- Hospital das Clínicas da UFMG - Belo Horizonte, Brazil
- FutureMeds GmbH - Berlin, Germany
- Podlaskie Centrum Psychogeriatrii - Bialystok, Poland
- Neurozentrum Bielefeld - Bielefeld, Germany
- MentalMEDIC - Bielsko-Biala, Poland
- Heritage Medical Research Clinic - Calgary, Canada
- NeuroCentrix - Carlton, Australia
- The Second People's Hospital of Hunan Province - Changsha, China
- Attikon General University Hospital - Chaïdári, Greece
- Pharmakologisches Studienzentrum Chemnitz - Chemnitz, Germany
- The Fourth People's Hospital of Chengdu - Chengdu, China
- Scientia Investigacion Clinica S.C. - Chihuahua City, Mexico
- Uematsu Mental Clinic - Chikugo, Japan
- Jimbocho Mental Clinic - Chiyoda City, Japan
Showing 60 of 179 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →