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

Depressive Disorder, Major Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00300378
• Other study ID #: 3151A1-333
• Status: Completed
• Phase: Phase 3
• First received: March 7, 2006
• Last updated: December 3, 2007
• Start date: March 2006
• Est. completion date: January 2007

Study information

• Verified date: December 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Ministry of Health and Social CareEstonia: The State Agency of MedicineFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Latvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthPoland: Ministry of HealthRomania: State Institute for Drug ControlSlovakia: State Institute for Drug ControlSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• desvenlafaxine 50 mg

• desvenlafaxine 100 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

Croatia,  Estonia,  Finland,  France,  Latvia,  Lithuania,  Poland,  Romania,  Slovakia,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Global Clinical Improvement will be the key secondary efficacy variable.