The purpose of this study is to evaluate the sensitivity of the THINC-it tool, in measuring
change in cognitive deficits in individuals with MDD after receiving vortioxetine.
Vortioxetine is used in this study as an antidepressant to improve mood, cognition and
quality of life. "Cognition" refers to intellectual functions such as thinking,
understanding, learning and remembering. Vortioxetine is approved by Health Canada for the
treatment of MDD. In addition, vortioxetine has been reported to have a beneficial effect on
cognitive areas such as executive function, attention/speed of processing, and memory, that
are commonly affected negatively by MDD. Vortioxetine is recognized by Health Authorities in
the EU and many other countries as having a benefit on cognitive dysfunction (loss of
intellectual functions) in patients with MDD.Cognitive dysfunction is a highly persistent,
pervasive and progressive abnormality in young adults (i.e., 18-65 years) with MDD.
It has also been shown that among adults with MDD who are gainfully employed, measures of
cognition are a greater determinant of overall workplace performance than is total depression
symptom severity. Several lines of evidence indicate that cognitive deficits that persist
between episodes of depression are critical determinants of functional recovery in the
workplace. The functional implications associated with cognitive impairment provide the
impetus for systematic evaluation, measurement and assessment of the domains of cognition
expected to be impaired in this patient population.
To date, no measurement tool has been sufficiently validated and/or determined to be
sensitive to the cognitive deficits in younger adults with MDD. Major limitations of
available comprehensive psychometric tools include relative lack of availability, cost, lack
of access to most healthcare providers, and above all else, the lengthy time to administer.
Moreover, the need for a psychometrist to interpret the results adds to the complexity and
the costliness of such an endeavor.
It is imperative that any tool recommended for clinical utility be aligned with the busy
nature of a high-volume clinical practice. The ideal gold standard tool for assessing the
presence of cognitive dysfunction in MDD in the clinical environment should include, but not
be limited to, features such as good conceptual coverage of cognitive domains affected in
MDD, good sensitivity and reliability, and it should be relatively uninfluenced by culture
effects and practice effects. The tool would also need to be brief, easy to administer and
interpret, and complement busy clinical practice.
It is anticipated that the THINC-it tool will be free of charge and downloadable from the
THINC-it website for use in the primary care and specialty setting. The THINC-it tool will be
accessible via computers/tablets, will take 20 minutes to self-administer in a clinical
setting, and the performance results will be immediately available.