A Multicenter, Randomized, Double-blind, Paroxetine-referenced, Parallel-group Study to Evaluate the Safety, Efficacy, and Tolerability of 3 Fixed Doses (50mg, 100mg, AND 200mg) of Desvenlafaxine Succinate Sustained-release Tablets in Adult Outpatients With Major Depressive Disorder
Overview
- Phase
- Phase 3
- Intervention
- DVS SR
- Conditions
- Depressive Disorder, Major
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Enrollment
- 807
- Primary Endpoint
- Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate sustained release (DVS SR) in subjects with major depressive disorder.
Detailed Description
The primary objective of this study is to investigate the efficacy, safety and tolerability of desvenlafaxine succinate sustained release (DVS SR) in Chinese, Taiwanese, South Korean, and Indian subjects with major depressive disorder (MDD) receiving daily doses of 50 mg, 100 mg, or 200 mg. The secondary objective is to obtain additional information regarding the efficacy of DVS SR in subjects with MDD receiving daily doses of 50 mg, 100 mg, or 200 mg. Additional objectives include obtaining general and functional quality of life outcome data.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Outpatient men and women at least 18 years of age.
- •Have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV), single or recurrent episode, without psychotic features.
- •Have a HAM D17 total score ≥20 at the screening and baseline (study day 1) visit.
Exclusion Criteria
- •Treatment with DVS SR at any time in the past.
- •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.
Arms & Interventions
A
DVS SR 50mg/day
Intervention: DVS SR
B
DVS SR 100mg/day
Intervention: DVS SR
C
DVS SR 200mg/day
Intervention: DVS SR
D
Paroxetine 20mg/day
Intervention: Paroxetine
Outcomes
Primary Outcomes
Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17)
Time Frame: 8 weeks
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.
Secondary Outcomes
- Clinical Global Impressions Scale-Improvement (CGI-I) Scores(8 weeks)
- Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores(8 weeks)
- Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline(Baseline and 8 weeks)
- Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline(8 weeks)
- Covi Anxiety Scale Score Mean Change From Baseline(8 weeks)
- Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline(8 weeks)