A Phase II study of a histamine H3 receptor antagonist GSK239512 for cognitive impairment in stable schizophrenia subjects on antipsychotic therapy

LF Jarskog; MT Lowy; RA Grove; RSE Keefe; JP Horrigan; MP Ball; A Breier; RW Buchanan; CS Carter; JG Csernansky; DC Goff; MF Green; JT Kantrowitz; MS Keshavan; M Laurelle; JA Lieberman; SR Marder; P Maruff; RP McMahon; LJ Seidman; MA Peykamian

Journal article

A Phase II study of a histamine H3 receptor antagonist GSK239512 for cognitive impairment in stable schizophrenia subjects on antipsychotic therapy

LF Jarskog, MT Lowy, RA Grove, RSE Keefe, JP Horrigan, MP Ball, A Breier, RW Buchanan, CS Carter, JG Csernansky, DC Goff, MF Green, JT Kantrowitz, MS Keshavan, M Laurelle, JA Lieberman, SR Marder, P Maruff, RP McMahon, LJ Seidman Show all

Schizophrenia Research | Published : 2015

DOI: 10.1016/j.schres.2015.01.041

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 7weeks (4weeks 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 w..

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University of Melbourne Researchers

Paul Maruff Author

Grants

Awarded by National Institutes of Health

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.