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Study Evaluating the Efficacy and Safety of Desvenlafaxine Tablets in Adult Outpatients With Major Depressive Disorder

Primary Purpose

Depressive Disorder, Major

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

desvenlafaxine 50 mg

desvenlafaxine 100 mg

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Depression, Adult, Outpatients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: A primary diagnosis of MDD Depressive symptoms for at least 30 days before the screening visit. Exclusion Criteria: Treatment with DVS SR at any time in the past. Known hypersensitivity to venlafaxine Significant risk of suicide based on clinical judgment

Sites / Locations

Outcomes

Primary Outcome Measures

The primary efficacy variable will be the change from baseline on the 17-item of the Hamilton Depression rating scale (HAM-D17 score) at the final on therapy evaluation

Secondary Outcome Measures

The Global Clinical Improvement will be the key secondary efficacy variable.

Full Information

NCT ID

NCT00300378

First Posted

March 7, 2006

Last Updated

December 3, 2007

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00300378

Brief Title

Study Evaluating the Efficacy and Safety of Desvenlafaxine Tablets in Adult Outpatients With Major Depressive Disorder

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (50 mg, 100 mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

Brief Summary

The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS SR versus placebo in subjects with Major Depressive Disorder. Additional objectives include testing both general and functional quality-of-life outcomes and satisfaction with therapy reported by the subject.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorder, Major

Keywords

Depression, Adult, Outpatients

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

480 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

desvenlafaxine 50 mg

Intervention Type

Drug

Intervention Name(s)

desvenlafaxine 100 mg

Primary Outcome Measure Information:

Title

The primary efficacy variable will be the change from baseline on the 17-item of the Hamilton Depression rating scale (HAM-D17 score) at the final on therapy evaluation

Secondary Outcome Measure Information:

Title

The Global Clinical Improvement will be the key secondary efficacy variable.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: