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Selection of cognitive tests for trials of therapeutic agents

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    The TMT-B specifically measures processing speed and executive function (e.g., working memory) (McIntyre et al., 2013). Objective measures of cognitive functions in persons with mood disorders do not correlate with subjective measures of cognitive functions (Harrison et al., 2016; McIntyre et al., 2019). It is separately reported that self-reported cognitive deficits, as measured by the PDQ-5-D, are highly associated with psychosocial disability (Knight et al, 2018).

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    However, it is also crucial to ensure that the selected measures are sufficiently sensitive. There has been criticism of studies reporting lack of efficacy, but in which unreliable and insensitive measures were employed [49]. These same criticisms can be applied to cognitive safety studies.

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    Various typologies have been proposed to define and operationalize cognitive constructs. The conventional typology classifies cognitive functions into the subdomains of attention and concentration, processing speed, executive function, and learning and memory (Harrison, Lam, Baune, & McIntyre, 2016). Extent literature views these subdomains as interconnected and dissociable phenomena with unique, but overlapping, neurobiological substrates.

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    The floor and ceiling effects change the internal responsiveness, and the “assay sensitivity” seems to be the same as external responsiveness. A further dimension of test sensitivity has been “assay sensitivity” in which context test selectors have focused on evidence that the chosen measures have proven capable of capturing treatment effects [26]. Examples of positive “assay sensitivity” include the use of the Control Oral Word Association Test in studies of encenicline, the Digit Symbol Substitution Test (DSST) in studies of galantamine [27], and the Neuropsychological Test Battery in studies of AN1792 and donepezil [28,29].

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    Results from a meta-analysis indicate that the magnitude of the deficit in cognitive function in MDD is approximately 0.2–0.7 (Cohens d) commensurate with clinically significant cognitive impairment (Rock et al., 2014). Conventional screening/rating instruments for depressive symptoms [e.g. Patient health questionnaire 9 (PHQ-9)] do not provide sufficient assessment of the cognitive symptoms of depression (Harrison et al., 2016). More specifically, conventional depression methods rely on self-report of cognitive function which is not correlated with objective measures of cognitive function and do not capture the complexity and circumstances of how cognitive function affects patient-reported outcomes (PROs) and individuals with MDD.

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    However, further research using the THINC-it is necessary before we can be certain that the THINC-it is successful in identifying a subpopulation of individuals with MDD that exhibit impairments in cognitive function that, subsequently, experience poorer PROs (Harrison et al., 2016; McIntyre and Lee, 2016; Woo et al., 2016).

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