A multicenter, 10-week study to evaluate the efficacy and safety of 50 mg of desvenlafaxine succinate sustained-release formulation (DVS SR) versus placebo in the treatment of peri- and postmenopausal women with major depressive disorder
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
439
50-mg DVS SR tablets taken orally once daily.
Placebo tablets taken orally once daily.
Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8
HAM-D17, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, \& weight loss). Total score ranges from 0 to 52; higher scores indicate more severe depression. Change from baseline: score at observation minus score at baseline.
Time frame: Baseline, Week 8
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
CGI-I: 7-point scale in which the clinician rated how much the participant's condition has changed compared to baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Time frame: Week 8
Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Week 8
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.
Time frame: Baseline, Week 8
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 8
Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Change: score at observation minus score at baseline.
Time frame: Baseline, Week 8
Change From Baseline in Quick Inventory of Depressive Symptoms, 16 Question Self-report (QIDS-SR)
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Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, United States
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
Little Rock, Arkansas, United States
Pacific Clinical Research Medical Group
Arcadia, California, United States
Southwestern Research, Inc.
Beverly Hills, California, United States
Catalina Research Institute LLC
Chino, California, United States
Pacific Clinical Research Medical Group
Orange, California, United States
Pacific Clinical Research Medical Group
Upland, California, United States
Western Affiliated Research Institute
Denver, Colorado, United States
Radiant Research, Inc.
Denver, Colorado, United States
Connecticut Clinical Research
Cromwell, Connecticut, United States
...and 34 more locations
This is a 16-item self reported questionnaire that measures depressive symptoms. Improvement reported as change in depressive score. Score ranges from 0 to 42, with higher numbers indicating more severe symptom reporting. Change: score at observation minus score at baseline.
Time frame: Baseline, Week 8
Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Week 8
10 centimeter (cm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 10 = worst possible pain. Change: score at observation minus score at baseline.
Time frame: Baseline, Week 8