Welcome and state of ISCTM

A.G. Awad, President ISCTM

Organizational Structure and Functioning of Society

O. Ray

Topic I: Difficulties in Establishing Long-Term Efficacy for Psychotropic Drugs: Common Methodological Isues

To assure themselves that medications are effective in the long-term treatment of psychiatric disorders, clinicians desire evidence that medications maintain effects that have been established during acute treatment for exacerbations of an underlying major psychiatric disorder. To demonstrate efficacy in long-term treatment, the design currently preferred by some regulators is that patients be stabilized for 6 months on study medication and then randomized to placebo or active treatment. Relapse prevention paradigms address whether the time to relapse is delayed should that medication be discontinued. This session will examine the questions being addressed and the most effective ways to answer them.

R. Anand
M. Rapaport

Introduction

R. Anand

Clinical Requirements, Current Practice

M. Rapaport

Industry Perspective: Goals and Hurdles

G. Gharabawi

Industry Perspective: Goals and Hurdles

L. Alphs

Audience Discussion

Basis for Current Regulatory Requirements: Need for Change?

C. Sampaio

Panel Discussion: Directions for the Future

M. Thase
R. Bullock

TOPIC 2: DATA BLITZ(during dinner)

Attendees are encouraged to present during this session. Interesting issues, new methodological approaches, new ways of interpreting data, and new trial designs should be presented. Each presentation will be limited to a maximum of 4 minutes and 4 slides and will be followed by 5 minutes audience discussion.

TOPIC 3: Impact of Attrition on Outcome - Methodological and Statistical Approaches

Attrition from clinical trials often affects interpretation of safety and efficacy results. This session will present various techniques of dealing with missing data (e.g. Hot Deck Imputation, Carried forward methods, mixed model approaches, and multiple imputation) and the use of retrieved dropouts. Issues to consider when determining a reasonable approach to deal with missing data and strengths and weakness of analyses that use imputations and alternative paradigms to address these issues will be discussed.

Introduction

C. Chuang-Stein

Lecture: Impact Of Attrition On Outcome - Methodological And Statistical Approaches

A. Leon

TOPIC 4: Long-Term Treatment Trials in MCI/ AD

Developing medications for MCI presents a number of clinical and regulatory challenges. Prevention or delaying the transition from prediagnostic dementia states to fully expressed disease would be a boon to millions of persons. However, performing clinical trials in patients with MCI present many challenges, including diagnostic accuracy, establishing clinically valid endpoints, developing clinically feasible and ethically justifiable study designs that would also meet regulatory needs.

Moderator:
M. Farlow

Introduction

R. Anand

The Case for MCI

M. Farlow

Critical Review of Results from MCI Studies

L. Schneider

MCI Conundrums: A Regulator’s Perspective

S. Ferris

Audience Discussion

MCI: A Critique of the Concept and Proposed Methodologies

R. Krishnan

Panel Discussion and Summary

R. Bullock
C. Sampaio

TOPIC 5: Publication of Study Results - Positive. Negative. Or Failed: Damned if You Do and Damned if You Can't

R. Baldessarini

Industry Perspective: Where We Are Now and How We Got Here?

R. Mahmoud

Industry Perspective: A view to the future

Roundtable: Perspective from Invited Journalists and Editors See Selected Slides to the Right

A. Pande

J. Coyle
D. Jeste
H. Nasrallah
B. R. Olsen
A. Picard
P. Neighmond

TOPIC 1: Difficulties in Establising Long-Term Efficacy for Psychotropic Drugs: Common Issues: Position Paper

M. Rapaport

TOPIC 6: Use of Biological Markers as Endpoints in Clinical Trials of Psychiatric and Neurological Indications

Moderators:
R. Krishnan
S. Potkin

Introduction

R. Krishnan

Use of FDG PET as an Outcome Variable In Schizophrenia Trials

S. Potkin

Measures Of Neuronal Activity In Psychiatric Disease

P. Renshaw

Measures Of Neuronal Activity In Psychiatric Disease

P. Renshaw

Audience Discussion

Structural Neuroimaging as an Outcome Variable in MCI and AD Clinical Trials

M. Weiner

Role of PET Imaging in Different Phases Of Drug Development: Account of a Substance P Antagonist

S. Reines

Panel Discussion

C. Sampaio
P. Renshaw
M. Weiner
P.J. Snyder

TOPIC 4: Plenary Session; Long-Term Treatment Trials in MCI/AD: Position Paper

M. Farlow

Adjournment