drugset / Trial / NCT01844115
Safety, Efficacy and Tolerability of Vilazodone in (GAD) Generalized Anxiety Disorder
RandomizedParallel-groupTriple-blindTreatment
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
- 2013-04-30
- Primary completion
- 2014-03-31
- Completion
- 2014-03-31
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs Vilazodone; p = 0.0048; Least Squares Mean Difference -2.20 (95% CI -3.72 to -0.68); MMRM NCT01844115 ↗
paper statistically significant for vilazodone versus placebo on the HARS (-2.20 PMID 27232052 ↗
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.
- Durgam S, Gommoll C, Forero G, Nunez R, Tang X, Mathews M, Sheehan DV. Efficacy and Safety of Vilazodone in Patients With Generalized Anxiety Disorder: A Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Trial. J Clin Psychiatry. 2016 Dec;77(12):1687-1694. doi: 10.4088/JCP.15m09885.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vilazodone | Small molecule | 20 mg | Oral |
| Subject | Vilazodone | Small molecule | 40 mg | Oral |