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RecruitingPhase 3

A Study of Brenipatide 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 1)

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, a condition that causes depression. It tests whether brenipatide added to usual care is safe and helps delay the return of depression symptoms. It compares brenipatide with a placebo, a treatment with no active drug, added to 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 four periods as follows: a screening period that will last approximately 1 month, a treatment period with a potential post treatment period that combined will last a minimum of 12 months, and the follow up period that will last approximately 2 months.

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 a stable dose of your usual medicine for depression.
  • Be willing and able to stay in the study, attend required visits, and follow study steps.
  • Be able to give yourself study injections and store and use the study treatment as directed.
  • Be able to keep electronic or paper study diaries and answer required questionnaires.

Who can't join

  • Have ever had schizophrenia or another psychotic disorder, which can affect what you believe or sense is real.
  • Have ever had bipolar disorder, which causes major shifts in mood and energy.
  • Have ever had borderline personality disorder, which affects emotions and relationships.
  • Have ever had an eating disorder.
  • Have type 1 diabetes, or have had ketoacidosis (dangerous acid buildup in the blood) or a hyperosmolar state or coma (serious problems linked to very high blood sugar).
  • Have had a moderate or severe drug or alcohol use disorder within 180 days before screening.
  • Are actively suicidal or judged to be at high risk for suicide.
  • Received active treatment in another study, or do not know if you did, too close to screening. The required gap is 90 days or five half-lives of that treatment, whichever is longer. A half-life is the time it takes for half the treatment to leave the body.

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 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

Study sites (32)

CA

CT

FL

GA

IA

IN

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

MO

NV

NY

OR

PA

SD

TX

UT

VA

WA