Implementation considerations for multisite clinical trials with cognitive neuroscience tasks.

Multisite clinical trials aimed at cognitive enhancement across various neuropsychiatric conditions have employed standard neuropsychological tests as outcome measures. While these tests have enjoyed wide clinical use and have proven reliable and predictive of functional disability, a number of implementation challenges have arisen when these tests are used in clinical trials. These issues are likely to be magnified in future studies when cognitive neuroscience (CN) procedures are explored in these trials, because in their current forms CN procedures are less standardized and more difficult to teach and monitor. For multisite trials, we anticipate that the most challenging issues will include assuring tester competence, monitoring tester performance, specific challenges with complex assessment methods, and having resources available for adequate monitoring of data quality. Suggestions for overcoming these implementation challenges are offered.

[1]  M. Davidson,et al.  Cognitive impairment as a target for pharmacological treatment in schizophrenia , 1995, Schizophrenia Research.

[2]  Philip D. Harvey,et al.  The Brief Assessment of Cognition in Schizophrenia: reliability, sensitivity, and comparison with a standard neurocognitive battery , 2004, Schizophrenia Research.

[3]  Barbara A. Cornblatt,et al.  The continuous performance test, identical pairs version: II. Contrasting attentional profiles in schizophrenic and depressed patients , 1989, Psychiatry Research.

[4]  J. Gold,et al.  Overlooking the obvious: a meta-analytic comparison of digit symbol coding tasks and other cognitive measures in schizophrenia. , 2007, Archives of general psychiatry.

[5]  Philip D. Harvey,et al.  Effects of rivastigmine on cognitive function in patients with traumatic brain injury , 2006, Neurology.

[6]  J. Lieberman,et al.  The effects of atypical antipsychotic drugs on neurocognitive impairment in schizophrenia: a review and meta-analysis. , 1999, Schizophrenia bulletin.

[7]  Philip D. Harvey,et al.  Treatment of cognitive impairment in early psychosis: a comparison of risperidone and haloperidol in a large long-term trial. , 2005, The American journal of psychiatry.

[8]  K. Davis,et al.  Assessing changes in Alzheimer's disease: Memory and language. , 1986 .

[9]  J. Lieberman,et al.  Efficiency of the CATIE and BACS neuropsychological batteries in assessing cognitive effects of antipsychotic treatments in schizophrenia , 2008, Journal of the International Neuropsychological Society.

[10]  J. Lieberman,et al.  Comparative effect of atypical and conventional antipsychotic drugs on neurocognition in first-episode psychosis: a randomized, double-blind trial of olanzapine versus low doses of haloperidol. , 2004, The American journal of psychiatry.

[11]  Michael F. Green,et al.  NIMH-MATRICS survey on assessment of neurocognition in schizophrenia , 2004, Schizophrenia Research.

[12]  Philip D. Harvey,et al.  Studies of cognitive change in patients with schizophrenia following novel antipsychotic treatment. , 2001, The American journal of psychiatry.

[13]  R. Gur,et al.  A comparison of cognitive structure in schizophrenia patients and healthy controls using confirmatory factor analysis , 2006, Schizophrenia Research.

[14]  Michael F. Green,et al.  Baseline Neurocognitive Deficits in the CATIE Schizophrenia Trial , 2006, Neuropsychopharmacology.

[15]  K. Davis,et al.  Handbook for clinical memory assessment of older adults , 1986 .

[16]  References , 1971 .