Study Evaluating Desvenlafaxine Sustained-Release (DVS-SR) in Adult Outpatients With Major Depressive Disorder

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00277823

Collaborator

(none)

480

Enrollment

Locations

Duration (Months)

19.2

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS-SR versus subjects receiving placebo.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: DVS-SR 50 mg Drug: DVS-SR 100 mg Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Fixed Doses (50 mg, 100 mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder

Study Start Date :

Feb 1, 2006

Actual Study Completion Date :

Jan 1, 2007

Outcome Measures

Primary Outcome Measures

The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS SR versus subjects receiving placebo. []

Secondary Outcome Measures

Additional objectives include testing both general and functional quality-of-life outcomes and satisfaction with therapy reported by the subject. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical diagnosis of major depressive disorder
Must be able to swallow tablets
Must be at least 18 years of age.

Exclusion Criteria:

Clinical diagnosis of other psychiatric disorders
Significant risk of suicide
Unstable medical conditions.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Beverly Hills	California	United States	90210
2	Northridge	California	United States	91324
3	Farmington	Connecticut	United States	06030
4	Washington	District of Columbia	United States	20037
5	Miami	Florida	United States	33173
6	St. Petersburg	Florida	United States	33702
7	Marietta	Georgia	United States	30060
8	Smyrna	Georgia	United States	30080
9	Libertyville	Illinois	United States	60048
10	New Orleans	Louisiana	United States	70115
11	Farmington Hills	Michigan	United States	48336
12	Clementon	New Jersey	United States	08021
13	Moorestown	New Jersey	United States	08057
14	New York	New York	United States	10021
15	New York	New York	United States	10024
16	Dayton	Ohio	United States	45408
17	Toledo	Ohio	United States	43623
18	Oklahoma City	Oklahoma	United States	73103
19	Portland	Oregon	United States	97210
20	Philadelphia	Pennsylvania	United States
21	Charleston	South Carolina	United States	29407
22	Columbia	South Carolina	United States	29201
23	Salt Lake City	Utah	United States	84107
24	Seattle	Washington	United States
25	Brown Deer	Wisconsin	United States	53223