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

Wyeth

Status and phase

Completed

Phase 3

Conditions

Depressive Disorder, Major

Treatments

Drug: desvenlafaxine succinate sustained release

Genetic: Genotyping

Study type

Interventional

Funder types

Industry

Identifiers

NCT00824291

3151A1-4415

B2061006

Details and patient eligibility

About

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.

Enrollment

437 patients

Sex

All

Ages

19 to 74 years old

Volunteers

No Healthy Volunteers

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.