Skip to main content
OpenTrials
Completed

NCT Number: NCT00300378

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depressive Disorder, Major Behavior Behavioral Symptoms Depression Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rijeka, Croatia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

desvenlafaxine 50 mg

Drug

desvenlafaxine 100 mg

Drug

Primary outcomes

  1. 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 outcomes

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

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2007
First posted
Mar 8, 2006
Registry last updated
Dec 5, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.