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

2014-08-27 03:13:09 | BioPortfolio

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Depressive Disorder

Intervention

323U66 SR 150 mg tablet, 323U66 SR 150 mg placebo tablet

Location

GSK Investigational Site
Kumamoto
Japan
861-8002

Status

Not yet recruiting

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:09-0400

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