NCT01138007

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

Study AK1113351, a Fixed Dose Study of 323U66 SR in the Treatment of Major Depressive Disorder (MDD) - a Multi-center, Placebo-controlled, Randomized, Double-blind, Parallel-comparison Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 572 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	323U66 SR 150 mg tablet	323U66 SR 150 mg tablet is orally administered once in the morning and/or once in the evening during the teatment phase.
DRUG	323U66 SR 150 mg placebo tablet	323U66 SR 150 mg placebo tablet is orally administered once in the evening and/or once in the morning during the teatment phase.

Timeline

• Start date: 2010-06-17
• Primary completion: 2012-08-01
• Completion: 2012-08-07
• First posted: 2010-06-07
• Last updated: 2018-08-10
• Results posted: 2013-05-06

Locations

59 sites across 2 countries: Japan, South Korea