AMPA-NOVA 2 Trial for Adults Living With MDD:
Advanced Discovery Research is looking for adults age 18 and above to participate in a clinical research study of an investigational drug. An optional 3-year extension study is also available for qualified participants.
If you are diagnosed with major depressive disorder (MDD), you may qualify to participate in one of our clinical research studies.
All study-related visits, medical evaluation, tests, and study drugs will be provided at no cost. In addition, reimbursement for study-related time and travel may be available.[RH1]For these studies, NBI prefers not to list compensation.
You may qualify if you:
- Are at least 18 years of age
- Have have a primary diagnosis of Major Depressive Disorder (MDD)
- Are receiving at least 1 antidepressant medication
- Have have had inadequate response to up to 5 antidepressant medications
- Are not pregnant, breastfeeding or plannign to become preganant during the study
- Meet additional study criteria
How long will the study last?
The AMPA-NOVA 2 study will last up to14 weeks. Participants will have several visits to the clinic for ongoing evaluation to determine how you are responding during the study.
What can participants in this study expect?
Generally, there will be three study periods. First, there is a screening period, which can last up to 28 days. During the screening period, doctors will assess whether individuals are eligible to participate in the study.
Next is the treatment period, which will be 8 weeks and require 6 visits to the clinic. During this time, participants will receive the investigational drug or a placebo. A placebo is a substance that looks like the investigational drug but has no study drug in it. Participants will be chosen at random (by chance, like flipping a coin) to receive the investigational drug or the placebo.
The final portion of the study is the safety follow-up period, which will usually last about 2 weeks. 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.
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.Provide Your Contact Info: