MedTrace Logo

Study Evaluating Desvenlafaxine Succinate Sustained Release In Adults With Major Depressive Disorder

NCT00863798 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 682

Last updated 2011-05-06

Study results available
· View outcomes & findings →

Summary

The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of desvenlafaxine succinate sustained release (10 and 50 mg/day) in 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 10mg

10 mg tablet, once daily dosing for 8 weeks

DRUG

Desvenlafaxine Succinate Sustained-Release 50 mg

50 mg tablet, once daily dosing for 8 weeks

DRUG

placebo

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Wyeth is now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

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
2009-04-30
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States

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 NCT00863798 on ClinicalTrials.gov