This study focuses on people with Major Depressive Disorder (MDD), a serious mental health condition characterized by persistent feelings of sadness and loss of interest in daily activities. The research evaluates a new medication called NBI-1065845 when used together with existing antidepressant treatments in adults who have not responded well enough to current antidepressant medications alone.
The purpose of this research is to assess how safe and well-tolerated NBI-1065845 is when taken as an additional treatment alongside regular antidepressant medication. The study medication comes in the form of oral tablets that participants take along with their current antidepressant treatment.
This is a long-term study that lasts for approximately 52 weeks (one year). During this time, all participants receive the study medication NBI-1065845 while continuing their current antidepressant treatment at the same dose they were taking before joining the study. The study team monitors participants’ health and any side effects that may occur throughout the treatment period.
1Initial screening and eligibility confirmation
Your diagnosis of Major Depressive Disorder (MDD) will be confirmed
A medical assessment will verify that you have been taking oral antidepressants for at least 8 weeks
Your MADRS score (a depression severity scale) will be checked to ensure it is 18 or higher
2Starting the medication
You will receive the study medication NBI-1065845 in tablet form to take by mouth
You will continue taking your current antidepressant medication at the same dose throughout the study
The study medication will be taken as an additional treatment alongside your regular antidepressant
3Long-term treatment period
The treatment period will last for 52 weeks (one year)
Regular medical check-ups will monitor your health and any side effects
Your current antidepressant medication will remain unchanged during this period
4Safety monitoring
Any side effects or health changes will be recorded throughout the 52-week period
Regular assessments will track your response to the medication
Medical staff will monitor your overall health and well-being during the study
5Study completion
The study will conclude after 52 weeks of treatment
A final medical assessment will be conducted
Your participation will end after completing all required evaluations
Who Can Join the Study?
You must have been diagnosed with recurrent Major Depressive Disorder (MDD) that is moderate or severe, or have persistent depressive disorder (long-lasting depression)
Your current depression treatment with oral antidepressants has not worked well enough to improve your symptoms
You must have been taking oral antidepressant medications for at least 8 weeks and be willing to continue taking the same medication at the same dose throughout the study
Your depression severity score on the MADRS (Montgomery-Åsberg Depression Rating Scale – a tool that measures depression symptoms) must be 18 or higher when you are first evaluated
You must be able and willing to follow all study procedures and restrictions that the study doctor explains to you
You can be either male or female
You must be an adult (age 18-64)
Who Cannot Join the Study?
Current diagnosis of bipolar disorder (a mental health condition that causes extreme mood swings)
History of psychotic disorders (conditions that affect how your brain processes information)
Current substance use disorder within the past 6 months (problems with alcohol or drug use)
Significant risk of self-harm or suicide
Unstable medical conditions that could affect your safety during the study
Taking medications that could interact with the study drug
Pregnant or breastfeeding women
Previous participation in a clinical trial within the past 30 days
Known allergies or sensitivity to similar medications
Severe liver or kidney problems
History of seizures or epilepsy
Uncontrolled high blood pressure
Any condition that could interfere with the absorption of oral medication
Current use of certain antidepressant medications that cannot be safely stopped
Unable to follow study procedures or attend required visits
NBI-1065845 is an investigational medication being studied as an add-on treatment for major depressive disorder (MDD). It is being tested in combination with patients’ existing antidepressant medications to potentially improve treatment outcomes for depression. This is a long-term study focusing on understanding how safe the medication is and how well patients tolerate it when used over an extended period.
Major Depressive Disorder – A mental health condition characterized by persistent feelings of sadness, loss of interest in activities, and decreased energy that lasts for at least two weeks. The condition affects how a person thinks, feels, and manages daily activities, often causing changes in sleep, appetite, and concentration. People with this disorder may experience feelings of worthlessness, difficulty making decisions, and reduced physical activity. The condition can develop gradually and may be triggered by life events or occur without an obvious cause. It affects emotional and physical well-being, influencing both personal and professional aspects of life. The disorder can vary in intensity from mild to severe, with symptoms fluctuating over time.
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