Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) in the Treatment of Major Depressive Disorder

Pfizer

Status and phase

Completed

Phase 3

Conditions

Major Depressive Disorder

Treatments

Drug: placebo

Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00798707

3151A1-3359-WW

B2061003

3151A1-3359

Details and patient eligibility

About

The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of DVS SR (25 and 50 mg/day) in the treatment of adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.

Enrollment

709 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive symptoms for at least 30 days prior to screening)
Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of >= 20
Clinical Global Impressions Scale-Severity (CGI-S) score of >= 4

Exclusion criteria

Clinical instability - 25% or greater increase/decrease in HAM-D 17 total score from screening to baseline
Significant risk of suicide as assessed by clinician judgement, HAM-D 17 and Columbia Suicide-Severity Rating Scale scores Other eligibility criteria also apply