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RecruitingPhase 3

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

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Major Depressive Disorder (RENEW-MDD- 2)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults with major depressive disorder who take stable depression medicine. It tests whether brenipatide, added to usual care, is safe and helps delay the return of depression symptoms compared with a placebo (a treatment with no active drug) plus usual care.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a diagnosis of major depressive disorder.
  • Be taking stable doses of your usual depression medicine.
  • Be willing and able to attend study visits and follow study steps for the full study.
  • Be able to give yourself injections and store and use the study treatment as directed.
  • Be able to keep electronic and paper study diaries, as needed, and fill out questionnaires.

Who can't join

  • Have ever had schizophrenia or another psychotic disorder (conditions that affect your sense of reality), bipolar disorder (extreme mood changes), borderline personality disorder (trouble managing emotions and relationships), or any eating disorder.
  • Have type 1 diabetes, or have had ketoacidosis (dangerous acid buildup in the blood), a hyperosmolar state (very high blood sugar with severe fluid loss), or coma.
  • Have had a moderate or severe alcohol or drug use disorder within 180 days before screening.
  • Are actively suicidal or judged to be at high risk of suicide.
  • Received active treatment in another study, or do not know whether you did, too close to screening. The waiting time is 90 days or five half-lives of that treatment (five cycles in which its level drops by half), whichever is longer.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (34)

AL

AZ

CA

FL

GA

IL

MA

MD

MI

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division · Troy, MI 48098 · Study contact · 248-312-0025Neil Fraser · Principal investigatorMore trials in Troy

NE

NY

PA

TX

UT

WA