About the AMPA Program

The AMPA Program consists of 5 clinical research studies testing an investigational drug to see if it is safe and whether it improves symptoms of MDD when taken with your current antidepressant medication(s). Participants will join based on their location and certain eligibility criteria.

About the Investigational Drug

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

A placebo (which looks like the investigational drug but contains no active ingredients) will be used to provide researchers with a baseline that they can compare to the investigational drug. 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 placebo or the investigational drug. Participants who receive the placebo will get the same care as participants who receive the investigational drug.

Who Can Participate?

Regardless of whether you are assigned the investigational drug or placebo, you will continue to take your current antidepressant medication(s) throughout study participation. To participate in 1 of these studies, 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

Additional requirements apply, which the study team will discuss with you.

Am I eligible?

The following overviews contain more information specific to each study in the AMPA Program.

AMPA NOVA-1 StudyAMPA NOVA-2 StudyAMPA NOVA-3 Study

About the AMPA-Nova Studies

These studies are researching an investigational drug to see if it is safe and whether it improves symptoms of MDD when taken alongside current antidepressant medication(s).

What to Expect

Each study is testing the same investigational drug using the same approach. The study you enter will depend on the location of study sites. Participation in 1 of these studies will last up to 14 weeks and have up to 8 visits.

  • Screening period28 days1 visit

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

  • Treatment period8 weeks6 visits

    You will continue to take your current antidepressant medication(s). You will also be randomly assigned (like flipping a coin) to receive either the investigational drug or a placebo. The study team will monitor your health while you are taking your assigned study treatment.

  • Follow-up period2 weeks1 visit

    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.

  • Long-term open-label study (AMPA-Vega 2)3 years42 visits

    If eligible, you may have the option to join an open-label study after the treatment period is complete. In the open-label study, there is no placebo, so all participants will receive the investigational drug. Your health will continue to be followed closely by the study team. Participation will last about 3 years.

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

AMPA VEGA-1 Study

About the AMPA-Vega 1 Study

This study is researching an investigational drug to see if it may delay relapse of MDD symptoms when taken alongside current antidepressant medication(s).

What to Expect

Participation in this study is variable in length. It is expected to last approximately 10 months and will be at least 5 months. Your participation 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 period28 days1 visit

    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 study by reading and signing the informed consent form.

  • Open-label treatment period16 weeks10 visits

    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 periodExpected to be at least 4 weeks, with a potential to be up to 24 months (monthly visits)

    • After the first 4 weekly visits, all subsequent visits are monthly.
    • 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 period2 weeks1 visit

    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.

  • Long-term open-label study (AMPA-Vega 2)Up to 3 years42 visits

    If eligible, you may have the option to join an open-label study after the maintenance period is complete. In the open-label study, there is no placebo, so all participants will receive the investigational drug. Your health will continue to be followed closely by the study team. Participation will last about 3 years.

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

AMPA VEGA-2 Study

About the AMPA-Vega 2 Study

This study is researching an investigational drug to see if it is safe and whether it improves symptoms of MDD when taken alongside current antidepressant medication(s) over a long period of time.

What to Expect

Participation in this study will last about 3 years.

  • Screening period28 days1 visit

    • 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 a study by reading and signing the informed consent form.
    • If you are joining this study after participating in the AMPA-Nova studies or the AMPA-Vega 1 Study, the screening visit is not required.

  • Treatment period1 year14 visits

    • 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.
    • There is no placebo in this study. All participants will receive the investigational drug.

  • Open-label extension period2 years26 visits

    You will continue taking the investigational drug and being monitored by the study team. Some of the visits during this period may be done virtually.

  • Follow-up period2 weeks1 visit

    After you stop taking the investigational drug, you will attend a final visit so that the study team can check on your health.

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