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Discover a New Path to Hope: Join a Study That’s Working to Improve Care for Depression
S
Steve Strakowski
Primary Investigator
Recruiting
18 years - 75 years
All
Phase
N/A
5 participants needed
1 Location
Brief description of study
Take the First Step Toward Feeling Better—Join Our Depression Study Today!
Living with depression can feel heavy, even on your best days. If you’re looking for new options—or simply wondering what else might help—you’re not alone.
This research study is exploring a possible new treatment for major depression, and you may be able to take part. Your experience could help bring new hope to you and others who face depression every day.
We’re looking for people like you to help us learn about brenipatide, a new medicine that might help with major depressive disorder (MDD). In this study, we want to learn more about the safety and effectiveness of brenipatide and if it can help lower your depression symptoms and keep them from coming back.
This study may be a good fit for you if:
- You have been diagnosed with major depressive disorder (MDD).
- You are taking a stable depression medicine.
- You do not have type 1 diabetes, recent substance use problems, or certain other mental health conditions.
- You can attend study visits at the IU Health Neuroscience Center in Indianapolis, IN and follow simple study steps, like giving yourself injections and filling out short logs or questionnaires.
Detailed description of study
As a Participant, Here’s What to Expect:
1. Before You Start (Screening – about 1 month)
First, the study doctor checks if the study is a good fit for you.
This includes:
- Questions about your health and medicines
- Basic checks like blood pressure, weight, and a short physical
- A few blood and urine tests
- An ECG (a simple heart test)
- Some short questionnaires and thinking tests
You will keep taking your regular depression treatment during this time.
2. Treatment Period (At Least 6 Months)
If you qualify, you will join the treatment phase.
During this time:
- You will get either brenipatide or a placebo
- You will give yourself an injection once a week
- You will keep taking your regular depression medication
- You will write down your injections in a simple log
- You will have regular check-ins to check your health, which include: taking your vital signs, blood and urine tests, completing short questionnaires, and receiving an ECG from time to time.
3. After Treatment (Follow-Up – about 8 weeks)
When you finish taking the study drug:
- You will stop the study injections
- The study doctor will check on your health a few more times
- You may have another set of basic tests
You will receive compensation for your participation, as well as the study drug, treatments, and procedures that are directly related to the study at no cost to you. Payment amount will depend upon the study activities you complete. The study staff will explain this further during your Screening visit.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Major Depressive Disorder, MDD
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Age: 18 years - 75 years
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Gender: All
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.
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
- Other medical conditions or comorbidities which, in the opinion of the Investigator, would interfere with safety, study compliance or data interpretation.
Updated on
31 Mar 2026.
Study ID: PSYCH-LILLY-RENEW-MDD-1, 28657
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