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Synergy in Action

NIMH/ISCTM Satellite Meeting

23 – 24 February, 2006   //   -

Satellite Meeting on the NIMH Initiative Regarding Treatment Development for Negative Symptoms

Day 1 (23 February 2006)

Welcome G Awad
Objectives of Meeting and Outline of Prior Work on NIMH Initiative
This presentation will provide a brief background on the NIMH initiative regarding treatment development for negative symptoms, its conceptual objectives and implementation to date.
W Fenton
Defining Negative Symptoms
This presentation will provide a working definition for negative symptoms, their differential diagnosis, and will outline confounding issues such as their relationship to cognitive and depressive symptoms. In addition, the presentation will address the question “Why have negative symptoms become the new focus for treatment target?” This will include an understanding of clinically meaningful improvements in negative symptoms and what would constitute a meaningful step forward in treatment effect (i.e. effect size).
S Marder
Open Discussion S. Leucht & R. Anand
Epidemiology and Long-Term Course of Negative Symptoms
This presentation will provide an epidemiological survey of the prevalence and incidence of negative symptoms in the schizophrenic population. The impact of these symptoms on quality of life and outcome will be discussed. In so doing, target populations for negative symptom treatments will be identified and trial design issues that arise from the long-term course of negative symptoms will be presented.
D Miller
Open Discussion  
Overview of Scales to Assess Negative Symptoms
In this presentation negative symptom scales that are in common use will be reviewed. Data supporting their strengths as well as their weaknesses will be discussed.
B Kirkpatrick
Open Discussion  
Subdomains of Negative Symptoms
This presentation will provide the evidence for the existence for negative symptom subdomains. The source of this evidence, its strength and its significance will be discussed. In particular the theoretical and clinical importance of these subdomains for prognosis and treatment of negative symptoms will be considered.
J Blanchard
Open Discussion  
The Neurobiology of Negative Symptom
The most prevalent neuroanatomical models of faulty circuitry in patients with predominantly negative symptoms involve consideration of dorsal-ventral prefrontal system dysfunction, monoamine dysregulation especially in the dopaminergic and serotonergic pathways, and a focus on imbalance in the input-output functions of supragranular and infragranular layers of prefrontal and temporal cortices. Another set of faulty prefrontal system throughput, especially in negative symptom patients, may also be inferred from the circuitry which factors in glutaminergic (and noradrenergic) inputs to layers III and IV may be result in reduced and asymmetric drive in competing cortico-subcortical loops of prefrontal systems.
J Fallon
Open Discussion  
Negative Symptoms as a Clinical Target: European Regulatory Perspective
In this session a representative from the European regulatory authority will present a European perspective on the regulatory issues that must be addressed to obtain an indication for the treatment of negative symptoms. Commentary will be provided on the regulatory position on some of the issues raised during this meeting.
C Sampaio
Open Discussion  

Day 2 (24 February 2006)

Process for Developing NIMH Scale for Negative Symptoms
This presentation will briefly summarize the objectives and process that has occurred to date for developing the NIMH Scale for Negative Symptoms.
B Kirkpatrick
A New Assessment for the Measurement of Expressivity in Schizophrenia
This presentation will briefly summarize the objectives and process that has occurred to date during the development of the expressivity items for the NIMH Scale for Negative Symptoms. Specific items selected for inclusion and their operational use will be described. Issues of reliability, validity, sensitivity to change, cultural sensitivity and facility for training will be discussed.
R Gur
Open Discussion  
A New Assessment for the Measurement of Anhedonia/Asociality in Schizophrenia
This presentation will briefly summarize the objectives and process that has occurred to date during the development of the anhedonia/asociality items for the NIMH Scale for Negative Symptoms. Specific items selected for inclusion and their operational use will be described. Issues of reliability, validity, sensitivity to change, cultural sensitivity and facility for training will be discussed.
A Kring
Open Discussion  
Design Of Clinical Trials For Negative Symptoms: A clinical/academic perspective
This presentation will provide a clinical view on the objectives of clinical trials for treatment of negative symptoms and translation of these objectives to an operative trial. This will include identifying the issues relevant for broad spectrum and adjunctive treatment and concerns about pseudospecificity.
R Buchanan
Design Of Clinical Trials For Negative Symptoms: A clinical/academic perspective
This presentation will provide a clinical view on the objectives of clinical trials for treatment of negative symptoms and translation of these objectives to an operative trial. This will include identifying the issues relevant for broad spectrum and adjunctive treatment and concerns about pseudospecificity.
L Alphs/
G Gharabawi
Open Discussion  
Identification and Management of Statistical Issues in Negative Symptom Trials
This presentation will address statistical issues that must be managed when designing, conducting and analyzing clinical trials of negative symptoms of schizophrenia. Issues of effects of attrition will be discussed, as will analytic paradigms and generalizability of results. In addition, issues related to long-term effects and maintenance of effect will be considered.
C Chuang-Stein
Open Discussion  
Negative Symptoms as a Clinical Target: US FDA perspective
In this session a representative from the FDA will present a US perspective on the regulatory issues that must be addressed to obtain an indication for the treatment of negative symptoms. Commentary will be provided on the regulatory position on some of the issues raised during this meeting.
T Laughren
Summary of Meeting
In this summary session key outcomes of the meeting will be provided and next steps and directions for the future identified.
R Anand
Adjourn G Awad / S Marder