Effect of Vortioxetine, Paroxetine, and Placebo on Sexual Functioning in Healthy Volunteers

Summary

The purpose of this study is to evaluate the effect of vortioxetine (10 and 20 mg, once daily) versus paroxetine (20 mg, once daily) on sexual functioning in healthy participants after 5 weeks of double-blind treatment.

Timeline

Start

2016-11-21

Primary completion

2017-05-31

Completion

2017-06-09

Outcome

Mixed primary results

registry LEAST_SQUARES_MEAN Paroxetine 20 mg: Change from Baseline at Week 5: -3.56 (Standard Error 0.758) score on a scale NCT02932904 ↗

registry LEAST_SQUARES_MEAN Vortioxetine 10 mg: Change from Baseline at Week 5: -0.82 (Standard Error 0.752) score on a scale NCT02932904 ↗

registry analysis (superiority test); Paroxetine 20 mg vs Vortioxetine 10 mg; p = 0.009; Least square (LS) Mean Difference 2.74 (95% CI 0.69 to 4.78); ANCOVA with LOCF; NCT02932904 ↗

registry analysis (superiority test); Paroxetine 20 mg vs Vortioxetine 20 mg; p = 0.303; LS Mean Difference 1.05 (95% CI -0.95 to 3.05); ANCOVA with LOCF; NCT02932904 ↗

registry analysis (superiority test); Paroxetine 20 mg vs Vortioxetine 10 mg; p = 0.002; LS Mean Difference 3.38 (95% CI 1.25 to 5.51); ANCOVA with LOCF; NCT02932904 ↗

registry analysis (superiority test); Paroxetine 20 mg vs Vortioxetine 20 mg; p = 0.129; LS Mean Difference 1.63 (95% CI -0.47 to 3.73); ANCOVA with LOCF; NCT02932904 ↗

registry analysis (superiority test); Paroxetine 20 mg vs Vortioxetine 10 mg; p <0.001; LS Mean Difference 4.31 (95% CI 2.19 to 6.43); ANCOVA with LOCF; NCT02932904 ↗

registry analysis (superiority test); Paroxetine 20 mg vs Vortioxetine 20 mg; p = 0.005; LS Mean Difference 3.06 (95% CI 0.95 to 5.17); ANCOVA with LOCF; NCT02932904 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Paroxetine	Small molecule	20 mg	Oral
Subject	Vortioxetine	Unknown	10 mg	Oral
Subject	Vortioxetine	Unknown	20 mg	Oral

Indications

No indication recorded.