A Phase III Prospective Active and Placebo-Controlled Randomized Trial of Vilazodone in the Treatment of Major Depressive Disorder

Abstract

BackgroundDepression is a leading cause of psychiatric morbidity in the modern world, and the introduction of selective serotonin reuptake inhibitors (SSRIs) is a revolution in the treatment of depression. Vilazodone, a novel SSRI and 5-HT1A partial agonist, received FDA approval in 2011 to treat the major depressive disorder (MDD) in adults. This study conducted in India aimed to evaluate the efficacy and safety of vilazodone when compared to escitalopram or placebo in patients with MDD. MethodsThis was a prospective, multicentre, randomized, comparative study of 375 participants over eight weeks of treatment with either vilazodone (10-40mg/day) or escitalopram (10-40 mg/day) or placebo in adult patients with MDD. Primary efficacy was assessed using the Hamilton Rating Scale for Depression (HAM-D-17); secondary efficacy was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) score and Hamilton Anxiety Scale (HAM-A) score. Safety parameters included adverse events (AEs), clinical laboratory results, vital signs, electrocardiogram ( ECG), and Columbia-Suicide Severity Rating Scale (C-SSRS). ResultsMean change in the HAM-D-17 total score from baseline to week 8 for vilazodone, escitalopram, and placebo-treated patients in intent-to-treat (ITT) population was:

An Open-Label Rater-Blinded Randomized Trial of Vilazodone versus Escitalopram in Major Depression

“…8 In an indirect comparison of vilazodone with several antidepressants, including escitalopram, all the studied antidepressants studied demonstrated similar efficacy 17 ; similar results were noted by investigators who compared vilazodone and escitalopram using a noninferiority design. 18 We did not find evidence for the early-onset hypothesis action of vilazodone. By directly stimulating the 5HT1A autoreceptors in the central nervous system in addition to augmenting synaptic serotonin (5HT) through Serotonin Reuptake Transporter inhibition, vilazodone, theoretically, may have a more rapid onset or more pronounced therapeutic action compared to conventional antidepressants.…”

“…8 In an indirect comparison of vilazodone with several antidepressants, including escitalopram, all the studied antidepressants studied demonstrated similar efficacy 17 ; similar results were noted by investigators who compared vilazodone and escitalopram using a noninferiority design. 18 …”

“…Items are scored on a 3-point or 5-point Likert scale, with total scores ranging from 0-52. The following cutoffs have been proposed for stratifying clinical severity: mild depression (8)(9)(10)(11)(12)(13)(14)(15)(16), moderate depression (17)(18)(19)(20)(21)(22)(23), and severe depression (≥24). 12 • Montgomery-Asberg Depression Rating Scale (MADRS) (secondary outcome): 13 This is a popular 10-item, observer-rated measure to assess the intensity of depressive symptoms.…”

Quality of Life and Medication Adherence in Patients With Major Depressive Disorder: An Interim Analysis of a Randomized Study

“…However, vortioxetine modulates serotonin receptors and impedes serotonin transport. With these pluses, we discovered that the vortioxetine group's corresponding drops in HDRS and MADRS scores were more pronounced than in the other two groups [20]. In light of these contrasting data, vortioxetine monotherapy might be considered as a prospective treatment option for MDD.…”

An Interim Analysis of a Randomized, Open-Label Study of Vilazodone, Escitalopram, or Vortioxetine for Major Depressive Disorder

“…The patients' scrupulous adherence to the treatment they received was the most fundamental challenge to the study's feasibility. Recent scientific studies [14][15][16][17][18][19] and meta-analyses [20,21] support the above drugs from their perspectives.…”