Efficacy of Cognitive Remediation in Patients With Schizophrenia or Schizoaffective Disorder Stabilized on Lurasidone

Summary

The investigators hypothesize that cognitive remediation will be superior to the active control group on the change from baseline to study end point of cognitive remediation phase on both co-primary outcome measures (standardized composite MATRICS score and Cognitive Assessment Interview).

Timeline

Start

2010-07

Primary completion

2013-10

Completion

2013-11

Publications

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• Background Kayser J, Bruder GE, Friedman D, Tenke CE, Amador XF, Clark SC, Malaspina D, Gorman JM. Brain event-related potentials (ERPs) in schizophrenia during a word recognition memory task. Int J Psychophysiol. 1999 Dec;34(3):249-65. doi: 10.1016/s0167-8760(99)00082-3.
• Background Kayser J, Tenke CE. Principal components analysis of Laplacian waveforms as a generic method for identifying ERP generator patterns: I. Evaluation with auditory oddball tasks. Clin Neurophysiol. 2006 Feb;117(2):348-68. doi: 10.1016/j.clinph.2005.08.034. Epub 2005 Dec 13.
• Background Kayser J, Tenke CE. Principal components analysis of Laplacian waveforms as a generic method for identifying ERP generator patterns: II. Adequacy of low-density estimates. Clin Neurophysiol. 2006 Feb;117(2):369-80. doi: 10.1016/j.clinph.2005.08.033. Epub 2005 Dec 13.
• Background Kayser J, Tenke CE, Gates NA, Kroppmann CJ, Gil RB, Bruder GE. ERP/CSD indices of impaired verbal working memory subprocesses in schizophrenia. Psychophysiology. 2006 May;43(3):237-52. doi: 10.1111/j.1469-8986.2006.00398.x.
• Background Kayser J, Tenke CE, Gates NA, Bruder GE. Reference-independent ERP old/new effects of auditory and visual word recognition memory: Joint extraction of stimulus- and response-locked neuronal generator patterns. Psychophysiology. 2007 Nov;44(6):949-67. doi: 10.1111/j.1469-8986.2007.00562.x. Epub 2007 Jul 19.
• Background Sambataro F, Reed JD, Murty VP, Das S, Tan HY, Callicott JH, Weinberger DR, Mattay VS. Catechol-O-methyltransferase valine(158)methionine polymorphism modulates brain networks underlying working memory across adulthood. Biol Psychiatry. 2009 Sep 15;66(6):540-8. doi: 10.1016/j.biopsych.2009.04.014. Epub 2009 Jun 17.
• Background McGurk SR, Twamley EW, Sitzer DI, McHugo GJ, Mueser KT. A meta-analysis of cognitive remediation in schizophrenia. Am J Psychiatry. 2007 Dec;164(12):1791-802. doi: 10.1176/appi.ajp.2007.07060906.
• Background McMahon RP, Arndt S, Conley RR. More powerful two-sample tests for differences in repeated measures of adverse effects in psychiatric trials when only some patients may be at risk. Stat Med. 2005 Jan 15;24(1):11-21. doi: 10.1002/sim.1837.
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• Background Nuechterlein KH, Barch DM, Gold JM, Goldberg TE, Green MF, Heaton RK. Identification of separable cognitive factors in schizophrenia. Schizophr Res. 2004 Dec 15;72(1):29-39. doi: 10.1016/j.schres.2004.09.007.
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• Background Ragland JD, Gur RC, Raz J, Schroeder L, Kohler CG, Smith RJ, Alavi A, Gur RE. Effect of schizophrenia on frontotemporal activity during word encoding and recognition: a PET cerebral blood flow study. Am J Psychiatry. 2001 Jul;158(7):1114-25. doi: 10.1176/appi.ajp.158.7.1114.
• Background Saykin AJ, Gur RC, Gur RE, Mozley PD, Mozley LH, Resnick SM, Kester DB, Stafiniak P. Neuropsychological function in schizophrenia. Selective impairment in memory and learning. Arch Gen Psychiatry. 1991 Jul;48(7):618-24. doi: 10.1001/archpsyc.1991.01810310036007.
• Background Weinberger DR, Egan MF, Bertolino A, Callicott JH, Mattay VS, Lipska BK, Berman KF, Goldberg TE. Prefrontal neurons and the genetics of schizophrenia. Biol Psychiatry. 2001 Dec 1;50(11):825-44. doi: 10.1016/s0006-3223(01)01252-5.
• Background Wexler BE, Stevens AA, Bowers AA, Sernyak MJ, Goldman-Rakic PS. Word and tone working memory deficits in schizophrenia. Arch Gen Psychiatry. 1998 Dec;55(12):1093-6. doi: 10.1001/archpsyc.55.12.1093.
• Background Wykes T, Brammer M, Mellers J, Bray P, Reeder C, Williams C, Corner J. Effects on the brain of a psychological treatment: cognitive remediation therapy: functional magnetic resonance imaging in schizophrenia. Br J Psychiatry. 2002 Aug;181:144-52. doi: 10.1017/s0007125000161872.
• Background Westfall PH. 1997. Multiple testing of general contrasts using logical constraints and correlations, J Am Stat Assoc, 92; 299-306.
• Background Westfall PH, Tobias RD, Rom D, Wolfinger RD, Hochberg Y. Multiple comparisons and multiple tests using the SAS7 system, SAS Institute, Inc., Cary NC, pp. 149-175, 335-343, 1999.
• Background Schafer, JL. Analysis of Incomplete Multivariate Data, New York: Chapman and Hall. 1997
• Background Mattay VS, Goldberg TE, Fera F, Hariri AR, Tessitore A, Egan MF, Kolachana B, Callicott JH, Weinberger DR. Catechol O-methyltransferase val158-met genotype and individual variation in the brain response to amphetamine. Proc Natl Acad Sci U S A. 2003 May 13;100(10):6186-91. doi: 10.1073/pnas.0931309100. Epub 2003 Apr 25.
• Background Little RJA, and Rubin DB. Statistical Analysis with Missing Data, Second Edition, New York: John Wiley & Sons, Inc. 2002.
• Background Cohen JD, Forman SD, Braver TS, Casey BJ, Servan-Schreiber D, Noll DC. Activation of the prefrontal cortex in a nonspatial working memory task with functional MRI. Hum Brain Mapp. 1994;1(4):293-304. doi: 10.1002/hbm.460010407.
• Background Friedman D. ERPs during continuous recognition memory for words. Biol Psychol. 1990 Feb;30(1):61-87. doi: 10.1016/0301-0511(90)90091-a.
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• Background Kayser, J., Tenke, C.E. Consensus on PCA for ERP data, and sensibility of unrestricted solutions. Clinical Neurophysiology, 117(3), 703-707. (2006c).
• Results Kantrowitz JT, Sharif Z, Medalia A, Keefe RS, Harvey P, Bruder G, Barch DM, Choo T, Lee S, Lieberman JA. A Multicenter, Rater-Blinded, Randomized Controlled Study of Auditory Processing-Focused Cognitive Remediation Combined With Open-Label Lurasidone in Patients With Schizophrenia and Schizoaffective Disorder. J Clin Psychiatry. 2016 Jun;77(6):799-806. doi: 10.4088/JCP.15m09998.
• Roberts MT, Lloyd J, Valimaki M, Ho GW, Freemantle M, Bekefi AZ. Video games for people with schizophrenia. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD012844. doi: 10.1002/14651858.CD012844.pub2.

Drugs

Indications