What to Expect

Participation in the AMPLIFY clinical trial is available only through one of our clinical trial sites, where licensed healthcare professionals are trained on the study protocol and study support staff will work with you to ensure you have the right information to make a decision about whether you would like to participate. The process for enrolling in a study follows strict guidelines from the FDA to ensure that patient safety and data are protected throughout the study and beyond.

Upon establishing contact with an eligible clinical trial site, a key initial step in the process is called Informed Consent, whereby trial participants are given a detailed packet of information (the Informed Consent Form or ICF) about the trial so that they can decide whether to participate. Trial site personnel will thoroughly review the ICF with potential participants so that they understand the trial design, the requirements of participants, and possible risks and benefits. If at this point you have decided to continue with participating in our trial, you will be asked to sign the ICF and enter a screening period designed to better understand your health status.

The screening process for AMPLIFY may take up to 5 weeks and will include questionnaires, medical assessments, and laboratory tests to determine if you are eligible for the study.

If eligibility criteria are met and you wish to continue with the study, here’s what to expect:

  • You will receive at random either the study medication (ABX-002) or placebo.
  • The treatment course in AMPLIFY is 6 weeks, during which you will take the study medication daily on top of your background SSRI or SNRI.
  • At various times during the study, you will be required to have either in-person or virtual visits with study healthcare providers and support staff. During each visit, you may be asked to complete surveys and medical assessments.
  • All study-related medical care, laboratory tests, and monitoring will be provided at no cost.
  • Upon completion of the treatment phase of the study, there will be a two-week follow-up period.
  • As a reminder, participation in any clinical trial is entirely voluntary and you may withdraw at any time.