Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Resilient Pharmaceuticals
This non-interventional study will serve as the long-term follow-up (LTFU) protocol for MDMA-assisted therapy clinical trials and will measure persistence of effectiveness using the CAPS-5 as a measure of PTSD symptom severity. The primary objective of this study is to evaluate the long-term effectiveness of MDMA-assisted therapy for treatment of PTSD as measured by the change in CAPS-5 Total Severity Score (actual or imputed) from the main study Baseline and Study Termination to LTFU IR Assessments (Visit 1). Additionally, this study will gather data to support health economics and cost effectiveness analyses of this treatment. Participants who have received at least one dose of Investigational Medicinal Product (IMP) in the main study will be eligible to participate in this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Enrolled in a MAPS-sponsored study of MDMA-assisted therapy for the treatment of PTSD
2. Have received Investigational Medicinal Product (IMP) in at least one Experimental Session in the main study
3. Agree to be contacted by study team at least six months after the last Experimental Session in the main study to schedule and participate in LTFU visits
You may not be if
1. Are not able to give adequate informed consent
2. Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with participation
