Safety, Efficacy and Tolerability of Vilazodone in Patients With Generalized Anxiety Disorder

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone relative to placebo in the treatment of generalized anxiety disorder (GAD).

Timeline

Start

2013-01-31

Primary completion

2014-01-29

Completion

2014-01-29

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Vilazadone; p = 0.0438; Least Squares Mean Difference -1.50 (95% CI -2.96 to -0.04); MMRM NCT01766401 ↗

paper The least squares mean difference in change from baseline to week 8 in the Hamilton Rating Scale for Anxiety total score was statistically significant for vilazodone versus placebo [-1.50 (-2.96, -0.04), P=0.0438]. PMID 26291335 ↗

Publications

• Khan A, Durgam S, Tang X, Ruth A, Mathews M, Gommoll CP. Post Hoc Analyses of Anxiety Measures in Adult Patients With Generalized Anxiety Disorder Treated With Vilazodone. Prim Care Companion CNS Disord. 2016 Apr 28;18(2):10.4088/PCC.15m01904. doi: 10.4088/PCC.15m01904. eCollection 2016.
• Gommoll C, Forero G, Mathews M, Nunez R, Tang X, Durgam S, Sambunaris A. Vilazodone in patients with generalized anxiety disorder: a double-blind, randomized, placebo-controlled, flexible-dose study. Int Clin Psychopharmacol. 2015 Nov;30(6):297-306. doi: 10.1097/YIC.0000000000000096.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vilazodone	Small molecule	20 mg	Oral
Subject	Vilazodone	Small molecule	40 mg	Oral

Indications