A Study of Brenipatide in Adult Participants With Major Depressive Disorder (NCT07412756)
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (12 items).
Location: Accellacare - Moorpark — Moorpark, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (179 Sites)
- Accellacare - Moorpark — Moorpark, California
- ATP Clinical Research — Orange, California
- Yale University School of Medicine — New Haven, Connecticut
- Encore Medical Research — Hollywood, Florida
- K2 Medical Research - Maitland — Maitland, Florida
- Life Medical Research Group Corp — Miami Gardens, Florida
- Floridian Clinical Research, LLC — Miami Lakes, Florida
- CLA Research — Naples, Florida
- Optimal Research Sites — Orange City, Florida
- Charter Research - Orlando — Orlando, Florida
- K2 Medical Research - Tampa — Tampa, Florida
- CenExel iResearch, LLC — Decatur, Georgia
- Indiana University Health Neuroscience Center — Indianapolis, Indiana
- Cedar Valley Medical Specialists — Waterloo, Iowa
- Pharmasite Research, Inc. — Baltimore, Maryland
- Adams Clinical Boston — Boston, Massachusetts
- K2 Medical Research - Foxborough — Foxborough, Massachusetts
- Adams Clinical Watertown — Watertown, Massachusetts
- Arcturus Healthcare , PLC, Troy Internal Medicine Research Division — Troy, Michigan
- Arch Clinical Trials — St Louis, Missouri
- Vector Clinical Trials — Las Vegas, Nevada
- Adams Clinical Harlem — New York, New York
- Summit Headlands — Portland, Oregon
- Suburban Research Associates — Media, Pennsylvania
- Penn Medicine: University of Pennsylvania Health System — Philadelphia, Pennsylvania
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.