The study evaluated the long-term safety of Desvenlafaxine Succinate (DVS) Slow Release (SR) during open-label treatment in adult outpatients who had a primary diagnosis of major depressive disorder (MDD). The study also evaluated the long-term response of subjects receiving DVS SR for clinical global evaluation, functionality, general well-being, pain, and absence of depressive symptoms (remission).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,403
Tablet were taken at a daily dose of 200 to 400 mg/day for a duration up to 10 months
Number (%) of Subjects Reporting Adverse Events during Treatment
Time frame: 10 months
Number (%) of Subjects With Changes in Vital Signs (Blood Pressure, Pulse Rate, Weight) of Potential Clinical Importance
Time frame: 10 months
Number (%) of Subjects With Laboratory Test Results (Hematology, Blood Chemistry, Lipid Profile, Urinalysis) of Potential Clinical Importance
Time frame: 10 months
Number (%) of Subjects With Electrocardiogram Results (Heart Rate, QTc interval) of Potential Clinical Importance
Time frame: 10 months
Change in Hamilton Depression Rating scale - 17 items version - (HAM-D17) mean score from baseline
Time frame: 10 months
Change in Montgomery Asberg Depression Rating Scale (MADRS)mean score from baseline
Time frame: 10 months
Change in Clinical Global Improvement Scale-Severity (CGI-S)mean score from baseline
Time frame: 10 months
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