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A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder

RecruitingPhase 3Ages 18 Years - 75 YearsAllEli Lilly and Company
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Meet the diagnostic criteria for major depressive disorder * Are on 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 spectrum 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
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What it tests

  • Brenipatide
  • Placebo
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Where

170 sites
University of Alabama at Birmingham - School of Medicine
Birmingham, United States
NoesisPharma, LLC
Phoenix, United States
Irvine Clinical Research
Irvine, United States
Healthy Brain Clinic
Long Beach, United States
Oakland Clinical
Oakland, United States
Concierge Clinical Trials
Valley Village, United States
JEM Research Institute
Atlantis, United States
Bradenton Research Center, Inc.
Bradenton, United States

โ€ฆand 162 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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