Journal article

A Phase II study of a histamine H-3 receptor antagonist GSK239512 for cognitive impairment in stable schizophrenia subjects on antipsychotic therapy

L Fredrik Jarskog, Martin T Lowy, Richard A Grove, Richard SE Keefe, Joseph P Horrigan, M Patricia Ball, Alan Breier, Robert W Buchanan, Cameron S Carter, John G Csernansky, Donald C Goff, Michael F Green, Joshua T Kantrowitz, Matcheri S Keshavan, Marc Laurelle, Jeffrey A Lieberman, Stephen R Marder, Paul Maruff, Robert P McMahon, Larry J Seidman Show all

Schizophrenia Research | ELSEVIER SCIENCE BV | Published : 2015

Abstract

This Phase II exploratory study assessed GSK239512, a brain penetrant histamine H₃ receptor antagonist, versus placebo on cognitive impairment in 50 stable outpatients with schizophrenia. Subjects were randomized to placebo or GSK239512 for 7 weeks (4 weeks titration). GSK239512 was associated with a small positive effect size (ES) on the CogState Schizophrenia Battery (CSSB) Composite Score (ES=0.29, CI=-0.40, 0.99) relative to placebo (primary endpoint). GSK239512's ES on CSSB domains were generally positive or neutral except Processing Speed, which favored placebo (ES=-0.46). Effects on the MATRICS Consensus Cognitive Battery were mostly neutral or favored placebo. GSK239512 was generally..

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Funding Acknowledgements

Research was funded by GlaxoSmithKline. Results submitted in collaboration with the Treatment and Evaluation Network for Trials in Schizophrenia (TENETS) group. The sponsor and authors of this paper would like to thank the patients and investigators who made this research possible, including study investigators Mohommad Bari, Christopher Benbow, Alan Breier, Robert W. Buchanan, Carter S. Cameron, Stephen Glass, Armen Goenjian, Morris Goldman, L. Fredrik Jarskog, Joshua Kantrowitz, Matcheri S. Keshavan, Jeffrey A. Leiberman, Stephen R. Marder, Joseph McEvoy, and Nirav Patel. Grant numbers for author Richard Keefe, NIH # 1R21-MH101685-01A1, NIH # 1R21-MH101685-02, Brain Plasticity/NIH: # RC3-MH090833-01 Singapore National Medical Research Council # NMRC/TCR/003/2008 Research Foundation for Mental Hygiene: PO #96074.