NCT00551109

SA4503 8-Week Study in Major Depressive Disorder (MDD)

A Phase II, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Safety and Efficacy of Treatment With SA4503, Once Daily for 8 Weeks, in Subjects With Major Depressive Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: M's Science Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy of SA4503 compared to placebo in the treatment of subjects with major depressive disorder (MDD). Secondary, to evaluate the safety of SA4503 compared to placebo in subjects with MDD.

Detailed description

Further study details as provided by M's Science Corporation:

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	placebo	placebo, oral administration, once daily for 8 weeks
DRUG	SA4503 Low	Low dose, oral administration, once daily for 8 weeks
DRUG	SA4503 High	High dose, oral administration, once daily for 8 weeks

Timeline

• Start date: 2007-11-01
• Completion: 2008-09-01
• First posted: 2007-10-30
• Last updated: 2008-12-18

Locations

5 sites across 1 country: Finland