drugset / Trial / NCT00733980

A Study of the Effects of a New Antidepressant Treatment (GSK561679) in Females With Major Depressive Disorder

NCT00733980 ↗

Phase 2 Completed 150 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindTreatment

Summary

This six-week study will evaluate the efficacy, safety and tolerability of GSK561679 compared to placebo in female subjects with major depressive disorder

Timeline

Start
2008-10-02
Primary completion
2010-06-18
Completion
2010-06-18

Outcome

Missed primary endpoint

registry analysis (superiority or other test); GSK561679 vs Placebo; p = 0.703; Mean Difference (Net) 0.2479 (80% CI -0.5887 to 1.0846); Mixed-Model Repeated-Measure analysis NCT00733980 ↗

release “no benefit of GSK561679 compared with placebo on both the Bech Melancholia and HAMD-17 endpoints” gcs-web.com ↗

Publications

  • Background GSK has concluded that it is not feasible to publish this study in a peer-reviewed scientific journal because the nature of the study is unlikely to be of interest to a journal. GSK is providing the attached study results summary with a conclusion.

Drugs

EvaluationDrugModalityDoseRoute
Subject VERUCERFONT Small molecule 350 mg —