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

Wyeth

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Desvenlafaxine Succinate Sustained-Release 10mg; Drug: Desvenlafaxine Succinate Sustained-Release 50 mg; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00863798

3151A1-3362

B2061005

3151A1-3362-US

Details and patient eligibility

About

The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of desvenlafaxine succinate sustained release (10 and 50 mg/day) in adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.

Enrollment: 682 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive symptoms for at least 30 days prior to screening).
• Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of >= 20.
• Clinical Global Impressions Scale-Severity (CGI-S) score of >= 4.

Exclusion criteria

• Clinical instability (25% or greater increase/decrease in HAM-D 17 total score from screening to baseline).
• Significant risk of suicide as assessed by clinician judgment, HAM-D 17 and Columbia Suicide-Severity Rating Scale scores Other eligibility criteria also apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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682 participants in 3 patient groups, including a placebo group

Desvenlafaxine succinate sustained release 10 mg

Experimental group

Treatment:

Drug: Desvenlafaxine Succinate Sustained-Release 10mg

Desvenlafaxine succinate sustained release 50 mg

Experimental group

Treatment:

Drug: Desvenlafaxine Succinate Sustained-Release 50 mg

Placebo

Placebo Comparator group

Treatment:

Drug: placebo