This study looks at how safe and effective brenipatide is for adults with Major Depressive Disorder (MDD). MDD is a condition causing long-lasting sadness and loss of interest. Brenipatide is given along with standard care, compared to a placebo (a fake treatment). The aim is to see if it delays the return of MDD symptoms.
The study includes four parts:
- A screening period lasting about 1 month.
- A treatment period, possibly followed by a post-treatment period, lasting at least 12 months.
- A follow-up period lasting about 2 months.
Participants must have MDD, be on stable medication, and be able to follow study rules, like self-injecting treatment and keeping diaries. They cannot have certain disorders like schizophrenia or diabetes, or be actively suicidal. The study requires attending visits and completing questionnaires.
- Study lasts at least 15 months in total.
- Participants must self-inject the treatment and keep diaries.
- People with certain conditions or who are suicidal cannot join.
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