Brenipatide added to usual care for adults with major depressive disorder
Tests brenipatide, added to usual care, in adults with major depressive disorder.
Plain-language title generated from the registry record
Registry title: A Study of Brenipatide in Adult Participants With Major Depressive Disorder
Key facts
- Where
- Arakawa City, Chikugo, Chiyoda City, Fukuoka, Fukushima, Ginowan, Hiratsuka, Karatsu, Kawasaki, Kōtō City, Kumamoto, Kure, Kurume, Meguro-ku, Nagasaki, Sagamihara, Setagaya City, Shibuya-ku, Shirakawa, Tokyo, Yamagata, Yokohama, and Yokosuka, JapanSee the 26 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07412756, who can take part
Where in Japan
- Abe Clinic - ArakawaArakawa City, JapanTaking people
- Uematsu Mental ClinicChikugo, JapanTaking people
- Jimbocho Mental ClinicChiyoda City, JapanTaking people
- Fukuoka University HospitalFukuoka, JapanTaking people
- Kokorono Clinic HiraoFukuoka, JapanTaking people
- Horikoshi Mental Somatic ClinicFukushima, JapanTaking people
- University of the Ryukyus HospitalGinowan, JapanTaking people
- Fujimidai HospitalHiratsuka, JapanTaking people
- Rainbow and Sea HospitalKaratsu, JapanTaking people
- Kishiro Mental ClinicKawasaki, JapanTaking people
- Monzen-nakacho Mental ClinicKōtō City, JapanTaking people
- Suizenji Life ClinicKumamoto, JapanTaking people
- Yuge HospitalKumamoto, JapanTaking people
- Kure Medical CenterKure, JapanTaking people
- Hirota ClinicKurume, JapanTaking people
- Senzoku Psychosomatic Medicine ClinicMeguro-ku, JapanTaking people
- Arata ClinicNagasaki, JapanTaking people
- Yutaka ClinicSagamihara, JapanTaking people
- Sangenjaya Shinkeika Shinryonaika ClinicSetagaya City, JapanTaking people
- Maynds Tower Mental ClinicShibuya-ku, JapanTaking people
- Nanko Kokorono ClinicShirakawa, JapanTaking people
- Himorogi Psychiatric Institute - Tokyo - IchigayatamachiTokyo, JapanTaking people
- Sakurazaka Clinic SophyAnceTokyo, JapanTaking people
- Yamagata Sakuracho HospitalYamagata, JapanTaking people
- Miki Mental ClinicYokohama, JapanTaking people
- Shioiri Mental ClinicYokosuka, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07412756EU 2025-522308-25-00
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: 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; 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.