AMPA-VEGA1

Summary

If your current antidepressant medication is not adequately improving symptoms of your Major Depressive Disorder (MDD), you may be eligible for the AMPA Program, which is researching an investigational drug to see if it is safe and whether it improves symptoms of MDD when taken with your current antidepressant medication(s).

After completing a screening period to determine eligibility, participants enter a 16-week open-label treatment phase during which all participants receive the investigational drug and attend regular study visits. Participants who complete this phase then enter a double-blind maintenance period, where they're randomly assigned (50/50) to either continue the investigational drug or switch to placebo while continuing their antidepressant medication(s). 

Study visits occur weekly at first and then monthly, with some visits conducted virtually. Participants remain in the maintenance phase until symptom relapse, study completion, or withdrawal from the study. After stopping study treatment, participants complete a follow-up safety visit unless they choose to enroll in an optional long-term open-label extension study (AMPA-VEGA2), in which all participants receive the investigational drug and are followed by the study team for up to 3 years.

To be included in  AMPA-VEGA1, participants must be / have:  

• A primary diagnosis of Major Depressive Disorder 
• Currently taking at least one (1) antidepressant medication 
• Had an inadequate response to (up to 5) antidepressant medication(s)
• Ability to come on-site for study visits

To be included in  AMPA-VEGA1, participants must not be / have: 

• Pregnant, breastfeeding, or planning on being pregnant during the study 
• Active substance use disorder 
• History of bipolar disorder diagnosis
• History of epilepsy, seizures, or convulsions

Keywords
Depression; Mental health; Mood disorders; Major depressive disorder