Validation of the THINC-IT Tool for Cognitive Dysfunction in Major Depressive Disorder

Clinical trial identifier: NCT02508493

 

http://thinc.progress.im

 

Rationale:          

There is a pressing need for measurement-based care in the safe and effective management of MDD. Currently, there is no validated consensually agreed upon tool to screen for and/or measure dysfunction in cognition in adults with Major Depressive Disorder (MDD). Moreover, there is no clinical metric that is currently available to determine the effect of treatment on the cognitive domain in adults with Major Depressive Disorder – a gold standard does not exist. The THINC tool broadly aims to close the gap by serving as an instrument that is brief, easy to use, freely available, and conceptually valid. 

 

Primary Objective:

  • To validate a tool capable of identifying the presence of cognitive dysfunction in adults with MDD.

 

Secondary Objectives:

  • To determine correlation between self-reported and clinician-administered cognition measures.

  • To determine correlation between self-reported/clinician-administered cognitive measures and cognitive dysfunction

 

No. of centers:

  • 10 centers across Canada

 

Study Design:   

  • This is a cross-sectional validation study comparing 100 individuals with MDD to 100 healthy controls.

  • Non-interventional study

 

Efficacy Measures:         

  • Digit Symbol Substitution Test, Trails Making Test-B, Choice Reaction Time, N-Back, and Perceived Deficits Questionnaire

  • THINC Tool will be validated as a screening tool (not a diagnostic tool)

 

 

REFERENCES:    

  1. McIntyre RS, Cha DS, Soczynska JK, Woldeyohannes HO, Gallaugher LA, Kudlow P, et al. Cognitive deficits and functional outcomes in major depressive disorder: determinants, substrates, and treatment interventions. Depress Anxiety 2013 Mar 6.

  2. McIntyre RS, Lophaven S, Olsen CK. A randomized, double-blind, placebo-controlled study of vortioxetine on cognitive function in depressed adults. Int J Neuropsychopharmacol 2014 Apr 30;1-11.

  3. Jaeger J, Berns S, Uzelac S, Davis-Conway S. Neurocognitive deficits and disability in major depressive disorder. Psychiatry Res 2006 Nov 29;145(1):39-48.

 

Would you like to participate in our validation study?

Find out more at clinicaltrials.gov

 

Feel free to contact us for more information at: 

thinc.research@gmail.com

Download the THINC-IT tool