Are you currently struggling with depression?

Ketamine is approved by the U.S. Food and Drug Administration (FDA) to be used with other drugs for anesthesia and as a pain reliever during procedures.  However, ketamine is not approved by the FDA to treat depression.  Brexpiprazole (Rexulti) is approved by the U.S. Food and Drug Administration (FDA) as an add-on treatment to an antidepressant medication to treat adults with major depressive disorder (MDD).

What is a clinical study?

• A clinical study is a scientific study on how a new or existing medicine, product, procedure or treatment works in people.
• Through clinical studies, doctors can find new and better ways to prevent, detect, diagnose, control and treat illnesses.
• All clinical studies are carefully monitored and regulated to ensure participant well-being.
• Participating in a clinical study is completely voluntary and will not affect the normal standard of care you receive.

What is the study about?

We are doing this research study to find out if brexpiprazole in combination with intranasal ketamine is effective in treating Major Depressive Disorder (MDD) in adult patients with MDD who have not responded to treatment with antidepressants alone.  We also want to find out if brexpiprazole in combination with intranasal ketamine is safe for people who are already taking a drug treatment for MDD.

Ketamine is approved by the U.S. Food and Drug Administration (FDA) to be used with other drugs for anesthesia and as a pain reliever during procedures.  However, ketamine is not approved by the FDA to treat depression. Brexpiprazole (Rexulti) is approved by the U.S. Food and Drug Administration (FDA) as an add-on treatment to an antidepressant medication to treat adults with major depressive disorder (MDD).

This research study will compare (brexpiprazole (pill) + intranasal ketamine) to (placebo pill + intranasal ketamine).  A placebo is a treatment that appears identical to the drug but that contains no drug with known antidepressant activity.  During this study, in addition to intranasal ketamine, you may get placebo (pretend treatment) instead of brexpiprazole.  Placebos are used in research studies to see if the results are due to the study drug or other reasons.

How long will I take part in this research study?

This study has an initial screening period, which will range from a minimum of 7 days to a maximum 28 days. The purpose is to ensure that only appropriate patients are entered into the study. If you are found eligible, you will be enrolled into the study and it will take you approximately 4 weeks to complete this research study.  During this time, we will ask you to make 12 study visits to research center.

What will happen during this study?

Before you can participate in this study, you will be screened for eligibility. If you are eligible, and you agree to participate, you will be randomly assigned (like flipping a coin) to receive injections of either the investigational drug or the placebo. You have a 50% chance of receiving the investigational drug and a 50% chance of receiving the placebo.

During your clinic visits for the study, doctors and the study staff will also conduct various tests and assessments to evaluate your health and progress. Some of these tests and assessments include, but are not limited to:

• Vital signs measurements
• Physical exams
• Blood and urine sample collections
• ECG (electrocardiogram) This test checks the electrical activity of your heart.  We will place several small, sticky pads on your chest, arms, and legs.  Each pad has a wire attached.  The wires connect to a machine that makes a recording of your heart rhythm.  This painless test takes about 15 minutes.
• Reviews of medication you are taking
• Reviews of any side effects

If you join the study, you can stop taking part at any time. If you choose to leave the study, doctors and the study staff will ask you to undergo some tests and assessments so they can evaluate your safety.

What are the risks and benefits related to this study?

You may or may not benefit from taking part to the study.  It is possible that your depression symptoms will improve while you are taking part in the study. The study may also benefit other people with MDD by furthering our understanding of the antidepressant effectiveness and safety of ketamine.

The study staff will provide you with a complete list of known side effects related to this product.

Because research studies can affect the health and safety of participants, you will be closely monitored during this study. Researchers designed a protocol for this study, which explains all of the study procedures in complete detail. An independent review board responsible for participant safety reviewed and approved this protocol and requires that it be followed exactly.

What if I have questions?

The study staff is always available to answer any questions or concerns you may have about the study or the investigational drug.