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Trial record 97 of 1316 for:    "Depressive Disorder" [DISEASE] AND Rating AND Major Depressive Disorder AND weeks

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
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: desvenlafaxine succinate sustained-release
Drug: placebo
Enrollment 439
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Desvenlafaxine Succinate Placebo
Hide Arm/Group Description Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks Matching placebo tablets once daily for 10 weeks
Period Title: Overall Study
Started 218 221
Treated 217 217
Completed 185 178
Not Completed 33 43
Reason Not Completed
Adverse Event             12             5
Lack of Efficacy             3             11
Lost to Follow-up             5             9
Physician Decision             0             3
Protocol Violation             1             0
Withdrawal by Subject             8             7
Discontinuation of study by sponsor             0             1
Other             3             3
Randomized, not treated             1             4
Arm/Group Title Desvenlafaxine Succinate Placebo Total
Hide Arm/Group Description Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks Matching placebo tablets once daily for 10 weeks Total of all reporting groups
Overall Number of Baseline Participants 217 217 434
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 217 participants 217 participants 434 participants
53.1  (6.85) 52.8  (6.58) 53.0  (6.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 217 participants 217 participants 434 participants
Female
217
 100.0%
217
 100.0%
434
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) Population: randomized participants who had a baseline HAM-D17 score, took at least 1 dose of investigational product, and had at least 1 postbaseline HAM-D17 evaluation. Last Observation Carried Forward (LOCF).
Arm/Group Title Desvenlafaxine Succinate Placebo
Hide Arm/Group Description:
Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
Matching placebo tablets once daily for 10 weeks
Overall Number of Participants Analyzed 216 216
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 22.8  (3.29) 22.4  (3.51)
Change at Week 8 -9.7  (6.54) -7.4  (6.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate, Placebo
Comments Null hypothesis: no difference between treatment groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF
Arm/Group Title Desvenlafaxine Succinate Placebo
Hide Arm/Group Description:
Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
Matching placebo tablets once daily for 10 weeks
Overall Number of Participants Analyzed 216 216
Measure Type: Number
Unit of Measure: participants
Very Much Improved 51 39
Much Improved 67 37
Minimally Improved 53 62
No Change 37 69
Minimally Worse 6 6
Much Worse 2 3
Very Much Worse 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments CGI-I analyzed as a categorical variable by Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores, controlling for the effect of region; p-value obtained from the alternative hypothesis of Row Mean Score Differences.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF
Arm/Group Title Desvenlafaxine Succinate Placebo
Hide Arm/Group Description:
Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
Matching placebo tablets once daily for 10 weeks
Overall Number of Participants Analyzed 216 216
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 4.4  (0.60) 4.3  (0.53)
Change at Week 8 -1.5  (1.20) -1.1  (1.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Desvenlafaxine Succinate Placebo
Hide Arm/Group Description:
Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
Matching placebo tablets once daily for 10 weeks
Overall Number of Participants Analyzed 216 216
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 31.0  (3.76) 30.6  (3.83)
Change at Week 8 -14.8  (9.09) -11.6  (9.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Quick Inventory of Depressive Symptoms, 16 Question Self-report (QIDS-SR)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF
Arm/Group Title Desvenlafaxine Succinate Placebo
Hide Arm/Group Description:
Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
Matching placebo tablets once daily for 10 weeks
Overall Number of Participants Analyzed 216 216
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 15.1  (3.22) 14.8  (3.60)
Change at Week 8 -5.9  (4.93) -5.2  (4.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.158
Comments Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.
Method ANCOVA
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF
Arm/Group Title Desvenlafaxine Succinate Placebo
Hide Arm/Group Description:
Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
Matching placebo tablets once daily for 10 weeks
Overall Number of Participants Analyzed 216 216
Mean (Standard Deviation)
Unit of Measure: cm
Baseline 4.0  (2.90) 4.0  (2.98)
Change at Week 8 -1.5  (2.69) -0.8  (2.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Desvenlafaxine Succinate Placebo
Hide Arm/Group Description Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks Matching placebo tablets once daily for 10 weeks
All-Cause Mortality
Desvenlafaxine Succinate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Desvenlafaxine Succinate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/217 (0.92%)   2/217 (0.92%) 
General disorders     
Non-Cardiac Chest Pain * 1  1/217 (0.46%)  0/217 (0.00%) 
Injury, poisoning and procedural complications     
Head Injury * 1  0/217 (0.00%)  1/217 (0.46%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Leukaemia * 1  0/217 (0.00%)  1/217 (0.46%) 
Nervous system disorders     
Cerebrovascular Accident * 1  1/217 (0.46%)  0/217 (0.00%) 
Subarachnoid Haemorrhage * 1  1/217 (0.46%)  0/217 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory Failure * 1  1/217 (0.46%)  0/217 (0.00%) 
Vascular disorders     
Aneurysm Ruptured * 1  1/217 (0.46%)  0/217 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA, version 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Desvenlafaxine Succinate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   100/217 (46.08%)   90/217 (41.47%) 
Gastrointestinal disorders     
Constipation * 1  17/217 (7.83%)  9/217 (4.15%) 
Diarrhoea * 1  13/217 (5.99%)  12/217 (5.53%) 
Dry Mouth * 1  14/217 (6.45%)  17/217 (7.83%) 
Nausea * 1  24/217 (11.06%)  16/217 (7.37%) 
Infections and infestations     
Nasopharyngitis * 1  15/217 (6.91%)  12/217 (5.53%) 
Upper Respiratory Tract Infection * 1  17/217 (7.83%)  19/217 (8.76%) 
Nervous system disorders     
Dizziness * 1  14/217 (6.45%)  10/217 (4.61%) 
Headache * 1  33/217 (15.21%)  25/217 (11.52%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA, version 14.0
Baseline characteristics are available for all treated participants (434) and not all randomized participants (439).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01121484     History of Changes
Other Study ID Numbers: 3151A1-3364
B2061029
First Submitted: May 3, 2010
First Posted: May 12, 2010
Results First Submitted: February 16, 2012
Results First Posted: March 30, 2012
Last Update Posted: April 4, 2012