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

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Desvenlafaxine Succinate

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.