Topic: issues and questions pertinent to the need for longer term efficacy data for proposed drug treatments for
chronic psychiatric disorders, and issues and questions pertinent to optimal study designs for obtaining valid information about longer-term benefits of drug treatment
Overview of Issues and Questions Thomas Laughren, M.D.
Presentations from Industry
Introductory Remarks and Review of Agenda Mark Ammann, Pharm.D.
Introduction/Overview Frederick Goodwin, M.D.
Rationale for Long-Term Treatment Earl Giller, M.D.
Disease and Compound Specific Approaches Robert A. Leadbetter, M.D.
to the Development of Psychotherapeutic Agents GlaxoSmithKline
Informative Studies of New Therapeutic Agents W. Z. Potter, M.D., Ph.D.
in Major Depression, GAD & Panic Merck Research Laboratories
Key Questions Engendered by Proposal to Joseph Camardo, M.D.
Change Long-Term Efficacy Requirements Wyeth Pharmaceuticals
Issues with Long-Term Trials in Bipolar Disorder Gary Sachs, M.D.
Long-Term Anti-Psychotic Trials: Mihael Polymeropoulos, M.D.
Challenges and Opportunities Vanda Pharmaceuticals
Long-Term Anti-Psychotic Treatment in Nina Schooler, Ph.D.
Schizophrenia: 30 Years of Data and Experience Department of Psychiatry
Some Statistical Issues Regarding the Use of Gene Laska, Ph.D.
Active Versus Placebo Controls in Nathan Kline Institute for Psychiatric Research
Longer-Term Efficacy Trials
Timing and Duration of Relapse Prevention David Michelson, M.D.
Trials in Psychiatric New Drug Development Eli Lilly and Company
Concluding Remarks Frederick Goodwin, M.D.
Open Public Hearing Speakers
George Awad, President ISCTM
Questions to the Committee