Get 20M+ Full-Text Papers For Less Than $1.50/day. Start a 14-Day Trial for You and Your Team.

Learn More →

The Social Brain, Stress, and Psychopathology

The Social Brain, Stress, and Psychopathology Opinion Editorial these domains are prominent with NMDA-channel blockade. recent negative studies to determine whether the failure to rep- As a phase 2 exploratory study, these results are quite licate can be understood by aspects of study design or imple- encouraging and consistent with a priori hypotheses. mentation or by participant heterogeneity. It is clear that ad- And now the bad news. On January 21, 2014, Roche an- vances in basic neuroscience and drug development must be nounced that 2 phase 3 trials of bitopertin for negative symp- matched by improved clinical trial methods including identi- toms failed to achieve primary end points. Once again, we are fication of biomarkers to reduce the problem of patient hetero- faced with the dilemma of an initial rigorous trial providing geneity. Otherwise, promising new agents associated with support for a compound that is well grounded in preclinical moderate therapeutic effects may be abandoned despite the and clinical studies, followed by a failure to replicate. We must potential for large and consistent effects if a personalized medi- wait until more information is available about the more cine approach can be achieved. ARTICLE INFORMATION negative symptoms of schizophrenia: 6. Weiser M, Heresco-Levy U, Davidson http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Psychiatry American Medical Association

The Social Brain, Stress, and Psychopathology

JAMA Psychiatry , Volume 71 (6) – Jun 1, 2014

Loading next page...
 
/lp/american-medical-association/the-social-brain-stress-and-psychopathology-J4xQNDSCpV
Publisher
American Medical Association
Copyright
Copyright 2014 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
2168-622X
eISSN
2168-6238
DOI
10.1001/jamapsychiatry.2014.288
pmid
24740473
Publisher site
See Article on Publisher Site

Abstract

Opinion Editorial these domains are prominent with NMDA-channel blockade. recent negative studies to determine whether the failure to rep- As a phase 2 exploratory study, these results are quite licate can be understood by aspects of study design or imple- encouraging and consistent with a priori hypotheses. mentation or by participant heterogeneity. It is clear that ad- And now the bad news. On January 21, 2014, Roche an- vances in basic neuroscience and drug development must be nounced that 2 phase 3 trials of bitopertin for negative symp- matched by improved clinical trial methods including identi- toms failed to achieve primary end points. Once again, we are fication of biomarkers to reduce the problem of patient hetero- faced with the dilemma of an initial rigorous trial providing geneity. Otherwise, promising new agents associated with support for a compound that is well grounded in preclinical moderate therapeutic effects may be abandoned despite the and clinical studies, followed by a failure to replicate. We must potential for large and consistent effects if a personalized medi- wait until more information is available about the more cine approach can be achieved. ARTICLE INFORMATION negative symptoms of schizophrenia: 6. Weiser M, Heresco-Levy U, Davidson

Journal

JAMA PsychiatryAmerican Medical Association

Published: Jun 1, 2014

References