A Study to Test NBI-1065845 in Adults with Major Depressive Disorder
This study will test a new investigational drug called NBI-1065845 to see if it helps improve symptoms of depression when taken with your current antidepressants. The study team will compare this drug with a placebo, a treatment with no medicine.
Why this Research Matters
Many adults who take antidepressants still have symptoms of depression. We want to find out if adding NBI-1065845 to current antidepressant treatment can help people feel better and see how well the body can handle taking the study drug.
What to Expect
If you join this study, you will first go through tests to see if you are eligible. This screening period will last up to four weeks. The study team will look over your medical and mental health history, check your vital signs, and do tests such as blood and urine samples, pregnancy testing (if applicable), and an ECG to check your heart. You will also have short interviews about your depression symptoms and current antidepressant treatment. After the screening period, you will begin the 8-week treatment period. You will keep taking your current antidepressant while also taking the assigned study drug, either NBI-1065845 or a placebo tablet daily. A placebo looks like the study drug but contains no active ingredients. Which tablet you get will be decided at random, like flipping a coin. This study is double-blind, which means neither you nor the study doctor will know which tablet you get. During the treatment period, the study team will check your health and how you are feeling. The study team will check your vital signs, and do tests such as blood and urine samples, and ask about your mood and daily life. You will also have brief interviews and fill out questionnaires to help track any changes in your depression symptoms over time. After you complete the 8-week treatment period, you may be invited to join a longer follow-up study afterward.
Study Duration
This study will last up to 14 weeks. You will have up to 8 total visits.
Who can Participate
You may be able to join if you:
- Are 18 years or older
- Have been diagnosed with depression (Major Depressive Disorder)
- Have ongoing symptoms even though you are taking antidepressant medication
- Have been on a steady does of your antidepressant for at least 8 weeks before screening
- Are not pregnant and agree to use bith control during the study
- Are willing to attend study visits (in person and vitural)
- Agree to dollow study instructions and take assign study drug
Study ID
Protocol Number: 25-0594
Compensation Information
Meet the Team
Principal Investigator