Posters - NCDEU: An Annual Meeting Sponsored by ASCP

Thursday, May 31, 2012
8:30 am – 10:00 am Regulatory Plenary - New FDA and EMA Initiatives
(continued) in Depression and Schizophrenia
Frank Lloyd Wright Salon E-F
8:50 am – 9:10 am FDA Review of Maintenance Trials for Major
Depressive Disorder: A 25-Year Perspective
Silvana Borges, M.D., Food & Drug Administration
US Food and Drug Administration (FDA) approves
antidepressants for marketing based on shortterm
clinical trials. The maintenance effectiveness
of antidepressants is also of considerable interest.
We have compiled efficacy data from a total of 14
antidepressant maintenance trials with a randomized
withdrawal design submitted to FDA since the
approval of the first second-generation antidepressant
in 1987. In these trials, responders to active drug
during an open‑label phase were randomized to
active drug or placebo, and observed for relapse over
a period of 6-12 months. Subjects on active drug had
significantly lower relapse rates than those on placebo
in every study. We will discuss the characteristics of
open-label and double-blind phases, relapse rates
in drug and placebo arms, and time-course of the
treatment effect.
9:10 am – 9:40 am FDA Initiative to Establish Data Standards in
Schizophrenia Drug Development
Phillip Kronstein, M.D., Food & Drug Administration
9:40 am – 10:00 am Discussion
This presentation will give a brief overview of the
FDA initiative to develop and implement standards
to represent study data submitted in support
of regulatory applications, including the latest
information and resources for sponsors. Our recent
experience in developing data standards specific to
schizophrenia drug programs will then be discussed.
10:00 am – 10:30 am Coffee Break
Frank Lloyd Wright Ballroom Foyer
56