NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

To be able to take part in this study, you would generally need to have been diagnosed with ongoing or returning major depression that is moderate or severe. Importantly, your current antidepressant medication shouldn't have fully helped your depression symptoms, even after you've been taking it consistently for at least eight weeks. You must be willing to continue taking your current antidepressant at the same dose throughout the study.

There are also reasons why you might not be able to join. For example, if you've had other serious mental health conditions that needed treatment in the last year, or if your doctor believes there's an immediate risk to your safety or the safety of others. Also, if your depression symptoms previously didn't get better after a specific type of treatment called electroconvulsive therapy (ECT) during your current depressive episode, you would not be able to take part. The study is open to both men and women aged 18 and over.

If you decide to take part in this study, you would continue to take your current antidepressant medication as prescribed. In addition, you would receive either the new study medication called NBI-1065845 or a placebo (a dummy pill, which contains no active medicine). Neither you nor your study doctor would know which one you are receiving – this is called a 'blinded' study and it helps ensure the results are fair.

You would have regular appointments at the clinic, which would involve check-ups with the study team, answering questions about your feelings, and likely filling out questionnaires about your symptoms. These visits help the doctors monitor your health and how you're feeling throughout the study. The total duration of your participation in the study, including follow-up periods, would be explained to you in detail.