Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder (DVS 3364)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01121484
|Study Director:||Pfizer CT.gov Call Center||Pfizer|