At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Brenipatide (drug), Placebo (drug)
- How long the study runs
- Study runs about 24 months (dates as stated)
- About the drug or intervention
- Brenipatide — drug: Administered SC · Placebo — drug: Administered SC
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 75 Years
- Who
- All
- Number of participants
- 1,000
- Started
- 2026-02-09
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for depressive disorder, major
- • Phase3 - 1,000 participants
- • 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
Who can take part?
- • Ages 18 Years to 75 Years
- • Diagnosed with depressive disorder, major
Where?
- • Edinburgh - Edinburgh Royal Infirmary
- • Exeter - Devon Partnership Trust
- • Glasgow - Queen Elizabeth University Hospital
- • London - The Maudsley Hospital
- • +6 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 75 Years
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ study visits, and are willing and able to follow study procedures as required, such as
- ✓ questionnaires
What the study is looking for
- ✓Meet the diagnostic criteria for major depressive disorder
- ✓Are on a stable the usual treatment medication for major depressive disorder
- ✓Are reliable and willing to make themselves available for the duration of the study and attend required study...
- ✓self-inject study intervention
- ✓store and use the provided blinded study intervention, as directed
Who cannot take part
- ✗Have a lifetime history or current diagnosis of the following:
- ✗schizophrenia or other psychotic disorder
- ✗bipolar disorder
- ✗borderline personality disorder, or
- ✗any eating disorder.
See the full criteria
Where Is This Study? (10 UK sites)
Edinburgh Royal Infirmary
Edinburgh EH16 4SA, United Kingdom
Devon Partnership Trust
Exeter EX2 5AF, United Kingdom
Queen Elizabeth University Hospital
Glasgow G51 4TF, United Kingdom
The Maudsley Hospital
London SE5 8AZ, United Kingdom
Clerkenwell Health - London - Welbeck Street
London W1G 8DR, United Kingdom
Queen's Medical Centre, Nottingham University Hospitals
Nottingham NG7 2UH, United Kingdom
Warneford Hospital
Oxford OX3 7JX, United Kingdom
St Bartholomew's Medical Centre
Oxford OX4 1XB, United Kingdom
Atlantic Medical
Penzance TR18 3DX, United Kingdom
Woodstock Bower Surgery
Rotherham S61 1AH, United Kingdom
How to Get in Touch
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Sponsor contactCONTACT
Physicians interested in becoming principal investigators please contact
Sponsor contactCONTACT
