Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD)

Pfizer

Status and phase

Completed

Phase 4

Conditions

Major Depressive Disorder

Treatments

Drug: desvenlafaxine succinate sustained-release 100 mg/day

Drug: placebo

Drug: desvenlafaxine succinate sustained-release 50 mg/day

Study type

Interventional

Funder types

Industry

Identifiers

NCT01432457

B2061028

3151A1-4420

Details and patient eligibility

About

A multicenter, 8-week study to evaluate the efficacy of 2 doses (50 and 100 mg/day) of desvenlafaxine succinate sustained-release (DVS SR) versus placebo in adult outpatients with major depressive disorder.

Enrollment

924 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female outpatients aged 18 years or older who are fluent in written and spoken English.
A primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode, without psychotic features.
A HAM-D17 total score ≥20 at the screening and baseline (study day -1) visits and no more than a 4-point improvement from screening to baseline.

Exclusion criteria

Significant risk of suicide based on clinical judgment.
Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
Current generalized anxiety disorder, panic disorder, or social anxiety disorder.
History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs.
Any unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.