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The efficacy profile of vilazodone, a novel antidepressant for the treatment of major depressive disorder.
Curr Med Res Opin 2012; 28(1):27-39CM

Abstract

OBJECTIVE

Vilazodone is a novel serotonin reuptake inhibitor and serotonin 1A receptor partial agonist approved for the treatment of major depressive disorder (MDD). This evaluation presents side-by-side efficacy data from two randomized, double-blind, placebo-controlled, short-term 8-week trials (referred to as randomized controlled trial [RCT]-1 [N = 410] and RCT-2 [N = 481]); efficacy data for demographic and clinical subgroups (derived from pooled RCT data); and effectiveness data from a 52-week, open-label, long-term study (N = 616). The objective is to summarize the efficacy profile of vilazodone at its approved dose of 40 mg/day.

METHODS

The main assessment in individual pivotal trials and pooled subgroup analyses was the change from baseline to end of treatment (EOT, 8 weeks) in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. Mixed-effects repeated-measures analyses were conducted in the placebo-controlled trials. Effectiveness analyses in the long-term study included mean MADRS score change over time.

RESULTS

Vilazodone-treated patients in both short-term studies showed greater improvement from baseline to EOT in mean MADRS scores than placebo-treated patients (least-squares mean [LSM] treatment difference: -3.2 [p = 0.001], RCT-1; -2.5 [p = 0.009], RCT-2). Clinical Global Impressions-Improvement mean scores at EOT reflected greater improvement with vilazodone compared with placebo in both studies (LSM treatment difference: -0.4 [p = 0.001], RCT-1; -0.3 [p = 0.004], RCT-2). MADRS response rates were significantly greater among patients receiving vilazodone versus those receiving placebo (RCT-1: 40.4% versus 28.1%, respectively [p = 0.007]; RCT-2: 43.7% versus 30.3%, respectively [p = 0.002]). The greater efficacy of vilazodone versus placebo was consistent for the majority of demographic and MDD characteristic subgroups. In the long-term study, the mean MADRS score improved from 29.9 (baseline) to 11.4 (week 8), 8.2 (week 24), and 7.1 (week 52).

CONCLUSION

Vilazodone 40 mg/day resulted in clinically meaningful, statistically significant improvement in MDD symptoms in two placebo-controlled, 8-week studies. Findings are supported by subgroup analysis and open-label, long-term effectiveness data.

TRIAL REGISTRATION

Randomized controlled trial 1: ClinicalTrials.gov identifier: NCT00285376, http://ClinicalTrials.gov/ct2/show/NCT00285376 ; randomized controlled trial 2: ClinicalTrials.gov identifier: NCT00683592, http://ClinicalTrials.gov/ct2/show/NCT00683592 ; open-label, long-term study: ClinicalTrials.gov identifier: NCT00644358, http://ClinicalTrials.gov/ct2/show/NCT00644358 .

Authors+Show Affiliations

Dogwood Pharmaceuticals, New Haven, CT 06511, USA. carol.reed@snet.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Evaluation Studies
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22106941

Citation

Reed, Carol R., et al. "The Efficacy Profile of Vilazodone, a Novel Antidepressant for the Treatment of Major Depressive Disorder." Current Medical Research and Opinion, vol. 28, no. 1, 2012, pp. 27-39.
Reed CR, Kajdasz DK, Whalen H, et al. The efficacy profile of vilazodone, a novel antidepressant for the treatment of major depressive disorder. Curr Med Res Opin. 2012;28(1):27-39.
Reed, C. R., Kajdasz, D. K., Whalen, H., Athanasiou, M. C., Gallipoli, S., & Thase, M. E. (2012). The efficacy profile of vilazodone, a novel antidepressant for the treatment of major depressive disorder. Current Medical Research and Opinion, 28(1), pp. 27-39. doi:10.1185/03007995.2011.628303.
Reed CR, et al. The Efficacy Profile of Vilazodone, a Novel Antidepressant for the Treatment of Major Depressive Disorder. Curr Med Res Opin. 2012;28(1):27-39. PubMed PMID: 22106941.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The efficacy profile of vilazodone, a novel antidepressant for the treatment of major depressive disorder. AU - Reed,Carol R, AU - Kajdasz,Daniel K, AU - Whalen,Heidi, AU - Athanasiou,Maria C, AU - Gallipoli,Susan, AU - Thase,Michael E, Y1 - 2011/11/23/ PY - 2011/11/24/entrez PY - 2011/11/24/pubmed PY - 2012/5/18/medline SP - 27 EP - 39 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 28 IS - 1 N2 - OBJECTIVE: Vilazodone is a novel serotonin reuptake inhibitor and serotonin 1A receptor partial agonist approved for the treatment of major depressive disorder (MDD). This evaluation presents side-by-side efficacy data from two randomized, double-blind, placebo-controlled, short-term 8-week trials (referred to as randomized controlled trial [RCT]-1 [N = 410] and RCT-2 [N = 481]); efficacy data for demographic and clinical subgroups (derived from pooled RCT data); and effectiveness data from a 52-week, open-label, long-term study (N = 616). The objective is to summarize the efficacy profile of vilazodone at its approved dose of 40 mg/day. METHODS: The main assessment in individual pivotal trials and pooled subgroup analyses was the change from baseline to end of treatment (EOT, 8 weeks) in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. Mixed-effects repeated-measures analyses were conducted in the placebo-controlled trials. Effectiveness analyses in the long-term study included mean MADRS score change over time. RESULTS: Vilazodone-treated patients in both short-term studies showed greater improvement from baseline to EOT in mean MADRS scores than placebo-treated patients (least-squares mean [LSM] treatment difference: -3.2 [p = 0.001], RCT-1; -2.5 [p = 0.009], RCT-2). Clinical Global Impressions-Improvement mean scores at EOT reflected greater improvement with vilazodone compared with placebo in both studies (LSM treatment difference: -0.4 [p = 0.001], RCT-1; -0.3 [p = 0.004], RCT-2). MADRS response rates were significantly greater among patients receiving vilazodone versus those receiving placebo (RCT-1: 40.4% versus 28.1%, respectively [p = 0.007]; RCT-2: 43.7% versus 30.3%, respectively [p = 0.002]). The greater efficacy of vilazodone versus placebo was consistent for the majority of demographic and MDD characteristic subgroups. In the long-term study, the mean MADRS score improved from 29.9 (baseline) to 11.4 (week 8), 8.2 (week 24), and 7.1 (week 52). CONCLUSION: Vilazodone 40 mg/day resulted in clinically meaningful, statistically significant improvement in MDD symptoms in two placebo-controlled, 8-week studies. Findings are supported by subgroup analysis and open-label, long-term effectiveness data. TRIAL REGISTRATION: Randomized controlled trial 1: ClinicalTrials.gov identifier: NCT00285376, http://ClinicalTrials.gov/ct2/show/NCT00285376 ; randomized controlled trial 2: ClinicalTrials.gov identifier: NCT00683592, http://ClinicalTrials.gov/ct2/show/NCT00683592 ; open-label, long-term study: ClinicalTrials.gov identifier: NCT00644358, http://ClinicalTrials.gov/ct2/show/NCT00644358 . SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/22106941/The_efficacy_profile_of_vilazodone_a_novel_antidepressant_for_the_treatment_of_major_depressive_disorder_ L2 - http://www.tandfonline.com/doi/full/10.1185/03007995.2011.628303 DB - PRIME DP - Unbound Medicine ER -