A 1-Year, Open-Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder

Abstract

Vilazodone, a selective serotonin (5-HT) reuptake inhibitor and 5-HT(1A) receptor partial agonist, was efficacious in two 8-week placebo-controlled studies in adults with major depressive disorder. This open-label, multicenter study assessed the long-term safety of vilazodone. Adult patients with a 17-item Hamilton Rating Scale for Depression score of 18 or greater received vilazodone according to a fixed-titration schedule to reach a dose of 40 mg/d continued up to 1 year. Safety assessments included adverse events (AEs), physical examinations, clinical chemistry, electrocardiograms, and the Changes in Sexual Functioning Questionnaire. Effectiveness was assessed with the Montgomery-Åsberg Depression Rating Scale and Clinical Global Impressions scales. The safety population comprised 599 patients; 254 patients completed 1 year of treatment. The most frequent AEs were diarrhea (35.7%), nausea (31.6%), and headache (20.0%); greater than 90% of these AEs were mild or moderate. Adverse events resulting in discontinuation in more than 1% of patients were nausea (1.3%) and diarrhea (1.2%). There were no clinically important changes in physical examinations, electrocardiograms, or clinical chemistries. Mean weight increased by 1.7 kg (observed cases). Changes in Sexual Functioning Questionnaire mean scores (observed cases) improved throughout treatment for both males and females. Montgomery-Åsberg Depression Rating Scale mean scores were 29.9 at baseline, 11.4 at week 8, and 7.1 at week 52 (observed cases). Vilazodone 40 mg/d for 1 year was safe and well tolerated by adults with major depressive disorder.

Efficacy and Safety of Vilazodone in Major Depressive Disorder

“…1 In the current study, early and statistically significant differences in treating symptoms of depression and associated anxiety were demonstrated for vilazodone versus placebo. Mean weight gain was small and similar for vilazodone and placebo, supporting results observed in the pivotal trials of vilazodone 10,12 ; however, weight gain is often not detected in acute 8-week trials, and longer duration may be necessary to reliably detect changes. In a previous long-term open-label study, 12 mean weight increase was 1.7 kg (3.7 lb) after 52 weeks of vilazodone treatment versus 0.37 kg (0.82 lb) in the current 8-week study.…”

“…Results of previous vilazodone studies that used prospective sexual dysfunction measures have shown that sexual functioning was similar for vilazodone-and placebo-treated patients in spite of prominent baseline sexual dysfunction. [10][11][12]30 Additionally, an 8-week trial may be too short of a time period to accurately assess sexual dysfunction. However, in a long-term 52-week open-label study of vilazodone, reports of sexual dysfunction treatment-emergent adverse events were similar to the 2 phase III 8-week trials.…”

“…[10][11][12] Spontaneous reporting of sexual dysfunction adverse events may underestimate sexual dysfunction, and this study did not include a scale to measure sexual function, so the sexual function results must be interpreted accordingly. Results of previous vilazodone studies that used prospective sexual dysfunction measures have shown that sexual functioning was similar for vilazodone-and placebo-treated patients in spite of prominent baseline sexual dysfunction.…”

“…Safety and tolerability findings were supported in a 1-year, open-label trial of vilazodone 40 mg/d (ClinicalTrials.gov identifier: NCT00644358). 12 Vilazodone was generally well tolerated in all trials; common adverse events, including diarrhea, nausea, and insomnia, were generally transient in nature and mild to moderate in severity. 13 The objective of the current study (ClinicalTrials.gov identifier: NCT01473394) was to further characterize the efficacy, safety, and tolerability of vilazodone 40 mg/d versus placebo for the treatment of MDD; a novel prospectively defined secondary endpoint (MADRS sustained response) was also assessed in this trial to evaluate treatment response that persisted beyond a single time point.…”

Antidepressant-Induced Sexual Side Effects: Incidence, Assessment, Clinical Implications, and Management

“…41 Two placebo-controlled studies and one long-term tolerability and safety trial found no SD associated with this compound. [42][43][44] As in other studies, both the treated and placebo groups experienced increased sexual function with no difference between the groups, suggesting a placebo effect on sexual function.…”