NCT00584974

A Safety, Efficacy and Tolerability Study of SEP-225289

A Double-Blind, Placebo-Controlled Study Examining The Safety, Efficacy, and Tolerability of SEP-225289 in Subjects With Major Depressive Disorder (Including Atypical and Melancholic Features)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 523 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

To determine the safety, efficacy and tolerability of SEP-225289 in subjects with Major Depressive Disorder

Detailed description

This is a randomized, placebo-controlled, double-dummy, multi-center study of the safety, efficacy and tolerability of SEP-225289 in male and female subjects with MDD. Subjects meeting DSM-IV criteria for Melancholic or Atypical Features specifier are eligible for participation. The study will consist of a screening period, which may last up to 2 weeks, an eight week (56 day) double-blind treatment period, a two week (14 day) wash-out, and a one week (7 day) follow up. Total subject participation will be approximately 91 days (13 weeks). This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	SEP-225289	0.5 mg SEP-225289
DRUG	SEP-225289	2.0 mg SEP-225289
DRUG	Venlafaxine	150 mg Venlafaxine
DRUG	placebo	Placebo

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-01-02
• Last updated: 2012-02-23

Locations

51 sites across 1 country: United States