MDD POC Study GSK372475 Subjects Depressive Disease

Summary

To evaluate the efficacy, safety and tolerability of GSK372475 compared with placebo in the treatment of outpatients subjects with major depressive disorder to exhibit decreased pleasure, interest and energy.

Timeline

Start

2006-12-19

Primary completion

2008-06-01

Completion

2008-10-15

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Placebo vs GSK372475; p = 0.485; Mean Difference (Final Values) -0.78 (90% CI -2.60 to 1.05); Mixed Model Repeated Measures (MMRM) NCT00420641 ↗

registry analysis (superiority or other test); Placebo vs GSK372475; p = 0.252; Mean Difference (Final Values) -0.53 (90% CI -1.28 to 0.23); MMRM NCT00420641 ↗

registry analysis (superiority or other test); Placebo vs GSK372475; p = 0.279; Mean Difference (Final Values) -1.66 (90% CI -4.19 to 0.87); MMRM NCT00420641 ↗

Publications

• Background Learned S, Graff O, Roychowdhury S, Moate R, Krishnan KR, Archer G, Modell JG, Alexander R, Zamuner S, Lavergne A, Evoniuk G, Ratti E. Efficacy, safety, and tolerability of a triple reuptake inhibitor GSK372475 in the treatment of patients with major depressive disorder: two randomized, placebo- and active-controlled clinical trials. J Psychopharmacol. 2012 May;26(5):653-62. doi: 10.1177/0269881111424931. Epub 2011 Nov 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	NS2359	Small molecule	1 mg	—
Subject	NS2359	Small molecule	1.5 mg	—
Subject	Paroxetine	Small molecule	20 mg	—
Subject	Paroxetine	Small molecule	30 mg	—

Indications