A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study To Evaluate Functional Outcome In Outpatients With Major Depressive Disorder Treated With Desvenlafaxine Succinare Sustained Release

Wyeth is now a wholly owned subsidiary of Pfizer0 sites437 target enrollmentFebruary 2009

ConditionsDepressive Disorder, Major

Interventionsdesvenlafaxine succinate sustained release Genotyping

Drugsdesvenlafaxine succinate sustained release

Overview

Phase: Phase 3
Intervention: desvenlafaxine succinate sustained release
Conditions: Depressive Disorder, Major
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 437
Primary Endpoint: Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a multicenter study to assess the health and well-being in subjects who are outpatients with major depressive disorder that take desvenlafaxine succinate sustained release (DVS SR) or placebo for 12 weeks.

Registry

clinicaltrials.gov

Start Date

February 2009

End Date

November 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility Criteria

Inclusion Criteria

•Outpatient men and women, between the ages of 18 to 75 years, fluent in both written and spoken English.
•Employed for 20 hours or more for a minimum of 1 month prior to baseline.
•Primary diagnosis of Major Depressive Disorder with symptoms for at least 30 days prior to baseline.

Exclusion Criteria

•Treatment with desvenlafaxine succinate sustained release at any time in the past and/or venlafaxine (Effexor or Effexor XR) 1 year prior to baseline.
•Treatment-resistant defined as any of the following failed treatments in the past 3 years: 3 or more previous adequate trials of \>=2 classes of antidepressant medication, electroconvulsive therapy, or psychotherapy (2 adequate trials).
•Current (within 12 months prior to the screening visit) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
•Clinically important abnormalities on physical examination, electrocardiogram (ECG), or laboratory evaluations.

Arms & Interventions

1

Intervention: desvenlafaxine succinate sustained release

2

Intervention: Genotyping

Outcomes

Primary Outcomes

Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12

Time Frame: At Baseline and Week 12.

HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss). Total score ranges from 0 to 52; higher scores indicate more depression. Change from baseline: mean at observation minus mean at baseline.

Secondary Outcomes

Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 12(At Baseline and Week 12.)
Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12(At Baseline and Week 12.)
Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12(At Baseline and Week 12.)
Change From Baseline on Work and Activities Item of HAM-D17 at Week 12(At Baseline and Week 12.)
Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 12(At Baseline and Week 12.)
Change From Baseline on Worry Anxiety Tension Scale (WATS) at Week 12(At Baseline and Week 12.)
Change From Baseline on Stress and Social Support Scales at Week 12(At Baseline and Week 12.)