AMPA-VEGA 1 Study

The AMPA-VEGA 1 Study is part of the AMPA Program and is researching an investigational drug to see if it may delay relapse of MDD symptoms when taken alongside current antidepressant medications.

Study Schedule

Participation in this study is variable in length. It is expected to last at least 5 months and may exceed 24 months. Participants can anticipate monthly visits, with a few weekly visits. The number of visits is related to the length of time you are in the study.

Screening: 28 days (1 visit)
Treatment: 16 weeks (10 visits)
Maintenance: Varies based on the length of time you are in the study
Follow-Up: 2 weeks (1 visit)
Open-Label Study: Up to 3 years (42 visits)

Screening period - A study doctor will evaluate you to see if this study is a good match. You will first need to give your consent, or permission, to join this clinical research study by reading and signing the informed consent form.

Open-label treatment period - You will continue to take your current antidepressant medication(s) and begin taking the investigational drug. The study team will monitor your health at regular visits. Some of these visits may be done virtually.

Double-blind maintenance period - You will have a 50/50 chance to either continue taking the investigational drug or switch to a placebo. Regardless of what study treatment you are assigned, you will continue to attend visits and be monitored by the study team. Some of these visits may be done virtually.

A placebo is a substance that looks like the investigational drug but contains no medicine.
You will be in the double-blind maintenance period until a relapse of your MDD symptoms occurs, the study ends, or you voluntarily withdraw.

Follow-up period - The purpose of this period is to check on your health after stopping the assigned study treatment. If you join the long-term open-label study, this follow-up period is not required.

Optional long-term open-label study - You may have the option to join a 3-year open-label study, during which you will continue to take your current antidepressant medication(s) and receive the investigational drug for an extended period of time. If you were assigned to the placebo previously, you will be switched over to the investigational drug.

Regardless of whether you are assigned to receive the investigational drug or placebo, you will continue to take your current antidepressant medication(s) throughout study participation.

Who Can Participate?

To participate in this study, you must:

Be at least 18 years old
Have a primary diagnosis of MDD
Be currently receiving at least 1 antidepressant medication
Have had inadequate response to up to 5 oral antidepressant medications
Not be pregnant, breastfeeding, or planning to become pregnant during the study

There are additional eligibility criteria and study requirements, which the study team will discuss with you.

What to Expect

Participants in this study will:

Receive the investigational drug (NBl-1065845) for 16 weeks
Continue taking their current antidepressant while also taking the assigned study treatment daily
Be assigned at random to either continue receiving the investigational drug (NBl-1065845) or begin receiving the placebo (the assigned study treatment)
Receive support from their study doctor and site staff, who will check on their health while they are in the study
Receive the assigned study treatment and study-related procedures at no cost
Have the option to be enrolled in other studies with NBl-1065845 upon their completion of this study
Be reimbursed for applicable travel costs and inconveniences while in the study, depending on their region

About the Investigational Drug (NBI-1065845)

The investigational drug being evaluated in this study is an oral tablet that will be taken once daily.

A placebo will be used to provide researchers with a baseline that they can compare the investigational drug to. To keep the research results as accurate as possible, participants, study doctors, and the study research teams will not know if you are receiving the investigational drug or placebo. Participants who receive the placebo will get the same care as participants who receive the investigational drug.

What You Should Know About Clinical Research Studies

Clinical research studies aim to answer specific questions about how investigational drugs work in the volunteers who take them.
You should feel fully informed about what to expect from your participation in a clinical research study.

Researchers use studies to:

Learn about the safety and effects of investigational medicines
Help find potential new ways of using certain approved medications
Answer specific health questions

Participation in any clinical research study is completely voluntary, and you may withdraw from the study at any time for any reason. Before volunteering for a clinical research study, it is important to weigh the potential risks and benefits of participation, which the study team will inform you of, as well as possible side effects. To make an informed decision, gather as much information as possible and talk to your healthcare providers about any questions you may have.

Regulations and policies have been developed to help protect the rights, safety, and well-being of people who take part in clinical research studies and to help ensure that these studies are conducted according to strict scientific and ethical principles. Before a clinical research study can begin, an institutional review board (IRB) or ethics committee (EC) must review and approve the research study.

This program is committed to supporting diversity, equity, and inclusion in clinical research. It is important that studies include participants from many backgrounds in order to accurately reflect the patients that the research serves.

To inquire about participation, please email the Yale Depression Research Program at ydrp@yale.edu or call us at (475)306-4188