This study is looking at Major Depressive Disorder, which is a mental health condition that causes persistent feelings of sadness and loss of interest in activities. The study will test a medication called azetukalner, which is also known as XPF-010. Some participants will receive azetukalner while others will receive placebo. The purpose of the study is to see if azetukalner works effectively in treating moderate-to-severe Major Depressive Disorder.
Participants will take either azetukalner capsules or placebo capsules by mouth once daily for a period of time. The dose of azetukalner that will be used is 20 milligrams per day. The study will measure changes in depression symptoms over several weeks, with particular attention to how participants feel after six weeks of treatment. The study will also look at changes in the ability to feel pleasure and overall improvement in the severity of depression symptoms.
This is a randomized, double-blind, placebo-controlled study, which means that participants will be assigned by chance to receive either the active medication or placebo, and neither the participants nor the doctors will know which treatment is being given until the study is completed. The treatment period will last up to 18 months. Participants may also continue taking their regular antidepressant medication during the study.
Czechia 
Finland 
Germany 
Poland 
Romania 
Slovakia 
Spain 
