Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder

Pfizer

Status and phase: Completed; Phase 3

Conditions: Depressive Disorder, Major

Treatments: Drug: Placebo; Drug: Duloxetine 60 mg/day; Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00384033

3151A1-335

Details and patient eligibility

About

The primary purpose of this study is to evaluate the efficacy and safety of two doses of DVS SR (50 and 100 mg/day) in the treatment of adults with Major Depressive Disorder.

Enrollment: 638 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A primary diagnosis of Major Depressive Disorder, single or recurrent episode, without psychotic features.
• Depressive symptoms for at least 30 days before the screening visit.
• Outpatient men and women at least 18 years of age.

Exclusion criteria

• Significant risk of suicide based on clinical judgment, including common suicidal thoughts and suicide having been considered as a possible solution even without specific plans or intent.
• Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation.
• 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; b) current (within 12 months before baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder; c) presence (within 12 months before baseline) of a clinically important personality disorder as assessed during the psychiatric assessments.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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638 participants in 4 patient groups, including a placebo group

Desvenlafaxine succinate sustained-release 50 mg

Experimental group

Treatment:

Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)

Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)

Desvenlafaxine succinate sustained-release 100 mg

Experimental group

Treatment:

Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)

Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Duloxetine 60mg

Other group

Description:

Active control to assess assay sensitivity

Treatment:

Drug: Duloxetine 60 mg/day