ProbarE AB är ett företag som bedriver kliniska läkemedelsprövningar. En livsviktig forskning, där din insats kan ge både dig själv och andra ett friskare liv.

Tired of hiding your depression?

Interested?

To learn more about this study, contact:
Ewa Karlsson, phone 0732-300 450 or email ewa.karlsson@probare.se

The AMPA-VEGA 2 STUDY is part of the AMPA PROGRAM. The study is investigating an investigational medication to determine whether it is safe and whether it reduces symptoms of major depressive disorder when taken together with one or more standard antidepressant medications over a longer period of time.

If your current antidepressant medication(s) do not provide sufficient relief from the symptoms of your major depressive disorder (MDD), you may be suitable for the AMPA-VEGA 2 STUDY. This study is evaluating an investigational medication to determine whether it is safe and whether it helps reduce symptoms of MDD when taken in combination with your current antidepressant medication(s).

Study Schedule

Participation in this study will last approximately 3 years and includes 42 study visits.

Screening – 28 days (1 visit)
A study doctor will evaluate you to determine whether this study is suitable for you. To join this clinical research study, you must first provide your consent by reading and signing an informed consent form.

Treatment – 1 year (14 visits)
You will continue taking your current antidepressant medication(s) and begin taking the investigational medication. Study staff will monitor your health at regular visits.

This study does not use a placebo (which looks like the investigational medication but contains no active ingredient). All participants will receive the investigational medication.

Extension – 2 years (26 visits)
You will continue taking the investigational medication, and study staff will continue to monitor you. Some visits during this period may be conducted remotely.

Follow-up – 2 weeks (1 visit)
After you stop taking the investigational medication, you will attend a final visit so that the study staff can check your health.

You will continue taking your current antidepressant medication(s) throughout the entire study.

About the Investigational Medication (NBI-1065845)

The investigational medication being evaluated in this study is a tablet taken orally once daily.

Who Can Participate

To participate in this study, you must:

  • Be at least 18 years old.
  • Have a primary diagnosis of major depressive disorder.
  • Currently be taking at least one antidepressant medication.
  • Have had an inadequate response to up to five different oral antidepressant medications.
  • Not be pregnant, breastfeeding, or planning to become pregnant during the study.

What You Can Expect

Participants in this study will:

  • Receive the investigational medication and study-related assessments at no cost.
  • Be reimbursed for applicable travel expenses and inconvenience related to study participation, depending on their region.
  • Receive support from their study doctor and clinic staff, who will monitor their health during the study.

There are additional eligibility criteria and study-related requirements that the study staff will discuss with you.

What You Should Know About Clinical Research Studies

Clinical research studies aim to answer specific questions about how investigational medications work in the volunteers who take them. These studies are part of the process toward approval of new medications.

You should feel fully informed about what to expect from participating in a clinical research study.

Researchers use studies to:

  • Learn more about the safety and effects of investigational medications.
  • Help find new ways to use certain approved medications.
  • Answer specific health-related questions.

Participation in a clinical research study is completely voluntary, and you may withdraw from the study at any time, for any reason. Before volunteering, it is important to consider the potential risks and benefits of participation, which the study staff will explain to you, along with possible side effects. To make an informed decision, you should gather as much information as possible and discuss any questions you have with your healthcare providers.

Regulations and policies are in place to help protect the rights, safety, and well-being of people who participate in clinical studies and to ensure that studies are conducted according to strict scientific and ethical principles. Before a clinical research study can begin, an institutional review board or ethics committee must review and approve the study.

This program is committed to supporting diversity, equity, and inclusion in clinical research. It is important that studies include participants from a wide range of backgrounds to accurately reflect the people the research is intended to benefit.

Interested?

To learn more about this study, contact:
Ewa Karlsson, phone 0732-300 450 or email ewa.karlsson@probare.se