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

NCT00798707 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 709

Last updated 2011-06-10

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Desvenlafaxine Succinate Sustained-Release (DVS SR)

25 mg tablet, once daily dosing for 8 weeks

DRUG

Desvenlafaxine Succinate Sustained-Release (DVS SR)

50 mg tablet, once daily dosing for 8 weeks

DRUG

placebo

Matching placebo tablets (25 or 50 mg). Daily dosing for 10 +/- 4 days during a placebo lead-in period, and then 8 weeks during the double-blind period.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States
  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00798707 on ClinicalTrials.gov