THINC-it Vortioxetine - Sensitivity to Change
Condition: Major Depressive Disorder; Cognitive Change
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Vortioxetine; THINC-it Tool
Intervention type(s): Drug; Other
Intervention description(s): Observing change in cognition using THINC-it tool in patients with MDD.; Digitalized cognitive test application administering the following cognitive test components:
Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) One-back working memory tool Trail Making Test B (TMT-B) Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)
Intervention MeSH terms: Vortioxetine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Determining the effectiveness of a new tool used to detect changes in cognition among individuals with MDD.
Masking: None (Open Label)
Primary purpose: Other