Brenipatide added to standard antidepressant treatment for adults with major depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults who meet diagnostic criteria for major depressive disorder and are on a stable standard-of-care medication will receive either brenipatide plus their usual treatment or a matching placebo plus their usual treatment under blinded conditions. Participation begins with a screening period of about one month, followed by a minimum 12-month treatment period and approximately a two-month follow-up. Participants will self-administer the blinded injection, keep electronic and paper diaries as instructed, and complete scheduled questionnaires and clinic visits. The study will collect safety and efficacy data focused on delaying recurrence of major depressive symptoms while monitoring adverse events.

Why it matters

Who can join: the full rules

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's running

• Accellacare - Moorpark
  Moorpark, California, United States Recruiting
• ATP Clinical Research
  Orange, California, United States Recruiting
• Yale University School of Medicine
  New Haven, Connecticut, United States Recruiting
• Encore Medical Research
  Hollywood, Florida, United States Recruiting
• K2 Medical Research - Maitland
  Maitland, Florida, United States Recruiting
• Life Medical Research Group Corp
  Miami Gardens, Florida, United States Recruiting

+130 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Brenipatide added to standard care for adults with major depressive disorder

  This study tests whether brenipatide, given alongside standard care, can help delay the return of depressive symptoms in adults with major depressive disorder.

  Recruiting at 47 sites Phase 3 Eli Lilly and Company · Birmingham, Alabama and 169 other locations · NCT07775300

• Student Precarity and Psychiatry: How Financial Struggles Relate to Depression and Loneliness

  This observational study looks at whether financial hardship and social isolation are linked to depression, suicidal thoughts, and loneliness among French university students.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris, IDF · NCT07618208

• Seltorexant (JNJ-42847922) as monotherapy for adults and older adults with major depressive disorder

  This trial will test whether seltorexant works better than a placebo to reduce depressive symptoms in adults and elderly people with major depressive disorder.

  Recruiting at 53 sites Phase 3 Janssen Research & Development, LLC · Bryant, Arkansas and 52 other locations · NCT07573176

• MOCHA: Inpatient Mental Health Care for High-Risk Pregnancy

  This study tests a collaborative mental health program for pregnant or recently postpartum patients hospitalized for medical problems to see if it can be delivered feasibly and acceptably.

  Recruiting Indiana University · Indianapolis, Indiana · NCT07540585

• Esketamine plus standard care for adolescents with major depressive disorder and acute suicidal thoughts or behavior

  This will test whether adding intranasal esketamine to usual care helps hospitalized adolescents with major depressive disorder and acute suicidal thoughts or behavior feel better faster than a psychoactive placebo plus usual care.

  Recruiting at 49 sites Phase 3 Janssen Research & Development, LLC · Birmingham, Alabama and 48 other locations · NCT07227454

• Everyday movement and subjective energy (MASE Project)

  This project tests whether increasing everyday, non-exercise activity can boost feelings of energy and reduce depressive symptoms in people with major depressive disorder or recent remission.

  Recruiting University of Bern · Bern · NCT07059234

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.