Table 4.
Summary of Efficacy Results from Longer-Term Studies of Vilazodone for Major Depression in Adults
| References | Study Design | Treatment Group (n) | Completion Rate | Main Efficacy Results | ||
|---|---|---|---|---|---|---|
| Depressive Symptom Change from Baseline | Response Rate | Remission Rate | ||||
| Robinson et al 201157 | 12-month, single-arm, open-label | Vilazodone 40 mg/day (n=616) | 41% | 2 months: −18.5a 6 months: −21.7a 12 months: −22.8a |
Not reported at any time point | Not reported at any time point |
| Crude relapse ratec | Time to first relapse, HR (95% CI)d | |||||
| Durgam et al 201858 e | 28-week, double-blind relapse prevention trialf | Vilazodone 40 mg/day (n=187) | 65% | +0.6b | 13% | 1.1 (0.6 to 1.9) |
| Vilazodone 20 mg/day (n=185) | 64% | +0.8b | 11% | 0.9 (0.5 to 1.6) | ||
| PLC (n=192) | 71% | +0.5b | 13% | Ref. | ||
Notes: aIndicates the change from baseline in MADRs total scores at each specified time point (2 months, 6 months, or 12 months). bIndicates change from baseline in MADRS total scores at the last non-missing assessment prior to randomization. cRelapse was defined as a MADRS total score of ≥ 18 and satisfying DSM-IV-TR diagnostic criteria for a depressive episode at any visit; MADRS total score of ≥ 18 at any two consecutive study visits; discontinuation of study drug owing to inefficacy (worsening of depression necessitating a switch in medication and a ≥ 2-point increase [worsening] from randomization in CGI-S score); or hospitalization due to worsening depression. dThe primary efficacy endpoint was time to first relapse (in days) during the double-blind relapse-prevention phase of the study. Hazard ratios (with 95% CIs) were reported without mean times to first relapse. eAll data shown in the table are from the double-blind relapse-prevention phase of the study. fThis study was conducted in two phases, beginning with 20 weeks of open treatment with vilazodone 40 mg/day. Patients who achieved positive treatment response during open treatment were randomized to 28 weeks of double-blind treatment with vilazodone 40 mg/day, vilazodone 20 mg/day, or placebo.
Abbreviations: CGI-S, Clinical Global Impression severity sub-scale; DB, double-blind; DSM-IV-TR, Diagnostic and Statistical Manual, 4th Edition, Text Revision; HR (95% CI), hazard ratio with 95% confidence interval; MADRS, Montgomery Asberg Depression Rating Scale; PLC, placebo.