At a glance
ClinicalIndex Comparison Record- ✓Age 18-65 years
- ✓Current major depressive episode (MDE) as part of MDD meeting DSM-5 criteria, confirmed by M.I.N.I 5.0
- ✓MADRS score ≥26 at screening and baseline
- ✓Current MDE duration at least 3 months
- ✕Current alcohol and/or substance use disorder
- ✕Comorbid psychiatric disorder (other than MDD) that is a focus of clinical concern per M.I.N.I 5.0
- ✕Medications approved or off-label for cognitive dysfunction (e.g., psychostimulants)
- ✕Medications for medical conditions affecting cognitive function (e.g., corticosteroids, beta-blockers)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Clinical Trial Evaluating Sensitivity to Change in Cognition Using the THINC-it Following Treatment With Vortioxetine in Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating Vortioxetine and THINC-it Tool for Major Depressive Disorder and Cognitive Change. Completed, enrolled 158 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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)