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

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

Journal: Schizophrenia Research

DOI: 10.1016/j.schres.2015.01.041.

Year Published: 2015

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 well tolerated with an adverse event profile consistent with the known class pharmacology. There
was no evidence of overall beneficial effects of GSK239512 for CIAS in this population.

Copyright © 2015 Elsevier B.V. All rights reserved.