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Synergy in Action

2005 Inaugural Meeting

22 – 24 February, 2005   //   Montreal, Canada

Day 1 (22 February 2005)

Related Publications:  
AC Leon, CH Mallinckrodt, C Chuang-Stein, DG Archibald, GE Archer, K Chartier
Randomized Controlled Clinical Trials:  Methodological Issues in Psychopharmacology
Biological Psychiatry, 2006; 59:1001-1005. PMID: 16503329
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 Issues – 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.  

Day 2 (23 February 2005)

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 pre-diagnostic 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
Roundtable: Perspective from Invited Journalists and Editors  
TOPIC 1: Difficulties in Establishing Long-Term Efficacy for Psychotropic Drugs: Common Issues: Position Paper M. Rapaport

Day 3 (24 February 2005)

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