Table 1.
Study Designs and Demographic Information
| Trial | Duration (weeks) | Key inclusion criteria | Randomized treatment groups | Primary endpoint | Key baseline demographics |
|---|---|---|---|---|---|
| Mahableshwarkar et al., 2015 | 8 | • Aged 18–65 years • Recurrent MDD according to DSM IV-TR criteria • Current MDE ≥3 months’ duration • MADRS total score ≥26 • Subjective report of cognitive dysfunction (e.g. difficulty with concentrating, thinking, learning/remembering new things) at baseline |
• Vortioxetine 10– 20mg/day* (n = 198) • Duloxetine 60mg/day (n = 210) • Placebo (n = 194) |
Change from baseline in DSST performance score |
• 66.0% female • Mean age: 45.3 years • Median length of current MDE: 156 days • Mean MADRS score: 31.6 |
| McIntyre et al., 2014 | 8 | • Aged 18–65 years • Recurrent MDD according to DSM IV-TR criteria • Current MDE ≥3 months’ duration • MADRS total score ≥26 |
• Vortioxetine 10mg/ day (n = 195) • Vortioxetine 20mg/ day (n = 207) • Placebo (n = 196) |
Composite cognition score comprising DSST† and RAVLT |
• 65.8% female • Mean age: 45.7 years • Median length of current MDE: 133 days • Mean MADRS score: 31.6 |
| Katona et al., 2012 | 8 | • Aged ≥65 years • Recurrent MDD according to DSM IV-TR criteria • Current MDE ≥4 weeks’ duration • MADRS total score ≥26 |
• Vortioxetine 5mg/day (n = 156) • Duloxetine 60mg/day (n = 151) • Placebo (n = 145) |
Change from baseline in HAM-D24 total score (Cognitive effects were measured using RAVLT and DSST) |
• 65.5% female • Mean age: 70.6 years • Median length of current MDE: 154 days • Mean MADRS score: 30.5 |
*Patients assigned to vortioxetine received 10mg/day on days 1–7 of the double-blind treatment period, with the option to increase to 20mg/day at the end of week 1 based on investigator judgment. For the remaining 7 weeks, the dose of vortioxetine was flexible at 10 or 20mg/day based on investigator judgment.
†DSST was a key secondary endpoint (multiplicity controlled) and was therefore subject to significance testing.
DSM-IV-TR, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision; DSST, Digit Symbol Substitution Test; HAM-D24, 24-item Hamilton Depression Scale; MADRS, Montgomery-Åsberg Depression Rating Scale; MDD, major depressive disorder; MDE, major depressive episode; RAVLT, Rey Auditory Verbal Learning Test.