Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder (DVS 3364)
|ClinicalTrials.gov Identifier: NCT01121484|
Recruitment Status : Completed
First Posted : May 12, 2010
Results First Posted : March 30, 2012
Last Update Posted : April 4, 2012
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: desvenlafaxine succinate sustained-release Drug: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||439 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Parallel-Group, Randomized, 10-Week, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of 50 mg Of DVS SR In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
|Experimental: desvenlafaxine succinate sustained-release||
Drug: desvenlafaxine succinate sustained-release
50-mg DVS SR tablets taken orally once daily.
Other Name: Pristiq
|Placebo Comparator: Placebo||
Placebo tablets taken orally once daily.
- Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8 [ Time Frame: Baseline, 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.
- Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) [ Time Frame: Week 8 ]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.
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Week 8 [ Time Frame: Baseline, 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.
- Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 8 [ Time Frame: Baseline, 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.
- Change From Baseline in Quick Inventory of Depressive Symptoms, 16 Question Self-report (QIDS-SR) [ Time Frame: Baseline, Week 8 ]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.
- Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Week 8 [ Time Frame: Baseline, 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01121484
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|