A Fixed Dose Study of 323U66 SR in the Treatment of Major Depressive Disorder (MDD)

Summary

This is a multi-center, placebo-controlled, randomized, double-blind, parallel-comparison study to confirm the efficacy of 323U66 Sustained Release (SR) orally administered to patients with MDD (Major Depressive Disorder) at doses level of 150 mg/day and 300 mg/day for 8 weeks based on the decrease in MADRS (Montgomery-Asberg Depression Rating Scale) total score, and to evaluate the safety based on adverse events, clinical laboratory tests and vital signs.

Timeline

Start

2010-06-17

Primary completion

2012-08-01

Completion

2012-08-07

Outcome

Missed primary endpoint

registry Placebo vs 323U66 SR 150 mg; p = 0.853; Least Squared Mean Difference -0.5 (95% CI -2.7 to 1.7) NCT01138007 ↗

Drugs

Indications