Skip Navigation



Schizophrenia Bulletin Advance Access published online on August 3, 2005
Schizophrenia Bulletin, doi:10.1093/schbul/sbi039
This Article
Right arrow Full Text (Rapid PDF)
Right arrow All Versions of this Article:
32/2/220    most recent
sbi039v1
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrowRequest Permissions
Google Scholar
Right arrow Articles by Laughren, T.
Right arrow Articles by Levin, R.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Laughren, T.
Right arrow Articles by Levin, R.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

Published by Oxford University Press 2005.

Article

Food and Drug Administration Perspective on Negative Symptoms in Schizophrenia as a Target for a Drug Treatment Claim

Thomas Laughren 1* and Robert Levin 2
1 Food and Drug Administration, DNDP (HFD-120), 5600 Fishers Lane, Rockville, MD 20853
2 Food and Drug Administration

* To whom correspondence should be addressed.
Thomas Laughren, E-mail: laughren{at}cder.fda.gov


  Abstract

Negative symptoms of schizophrenia are not adequately addressed by available treatments for schizophrenia. Thus, it is reasonable to consider them as a target for a drug claim. This article describes the thought process that the Food and Drug Administration (FDA) will undertake in considering negative symptoms of schizophrenia as a novel and distinct drug target. Beyond this basic question, this article identifies a number of design issues that the FDA needs to consider regarding how best to conduct studies to support claims for this target. These design issues include (1) what population to study, (2) what phase of illness to target, (3) whether to focus on the negative symptom domain overall or on some specific aspect of negative symptoms, (4) the role of functional measures in negative symptom trials, and (5) optimal designs for targeting drugs for add-on therapy or broad-spectrum agents.

Keywords: schizophrenia; negative symptoms; drug development.
Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?


This article has been cited by other articles:


Home page
 Schizophr BullHome page
M. Moscarelli
Passive and Active Schizophrenia: Toward a New Descriptive Micropsychopathology
Schizophr Bull, November 1, 2009; 35(6): 1183 - 1196.
[Abstract] [Full Text] [PDF]

Home page
 Schizophr BullHome page
A. M. Kring and E. K. Moran
Emotional Response Deficits in Schizophrenia: Insights From Affective Science
Schizophr Bull, September 1, 2008; 34(5): 819 - 834.
[Abstract] [Full Text] [PDF]

Home page
 Schizophr BullHome page
G. Foussias and G. Remington
Negative Symptoms in Schizophrenia: Avolition and Occam's Razor
Schizophr Bull, July 21, 2008; (2008) sbn094v1.
[Abstract] [Full Text] [PDF]

Home page
 Br. J. PsychiatryHome page
S. RUHRMANN, A. BECHDOLF, K.-U. KUHN, M. WAGNER, F. SCHULTZE-LUTTER, B. JANSSEN, K. MAURER, H. HAFNER, W. GAEBEL, H.-J. MOLLER, et al.
Acute effects of treatment for prodromal symptoms for people putatively in a late initial prodromal state of psychosis
The British Journal of Psychiatry, December 1, 2007; 191(51): s88 - s95.
[Abstract] [Full Text] [PDF]

Home page
 Schizophr BullHome page
R. W. Buchanan
Persistent Negative Symptoms in Schizophrenia: An Overview
Schizophr Bull, July 1, 2007; 33(4): 1013 - 1022.
[Abstract] [Full Text] [PDF]

Home page
 Schizophr BullHome page
A. S. Bellack, M. F. Green, J. A. Cook, W. Fenton, P. D. Harvey, R. K. Heaton, T. Laughren, A. C. Leon, D. J. Mayo, D. L. Patrick, et al.
Assessment of Community Functioning in People With Schizophrenia and Other Severe Mental Illnesses: A White Paper Based on an NIMH-Sponsored Workshop
Schizophr Bull, May 1, 2007; 33(3): 805 - 822.
[Abstract] [Full Text] [PDF]


Disclaimer: Please note that abstracts for content published before 1996 were created through digital scanning and may therefore not exactly replicate the text of the original print issues. All efforts have been made to ensure accuracy, but the Publisher will not be held responsible for any remaining inaccuracies. If you require any further clarification, please contact our Customer Services Department.