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Trial record 38 of 89 for:    DESVENLAFAXINE

Study Evaluating Desvenlafaxine Succinate Sustained Release In Adults With Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00863798
Recruitment Status : Completed
First Posted : March 18, 2009
Results First Posted : May 6, 2011
Last Update Posted : May 6, 2011
Sponsor:
Collaborator:
Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of desvenlafaxine succinate sustained release (10 and 50 mg/day) in adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Desvenlafaxine Succinate Sustained-Release 10mg Drug: Desvenlafaxine Succinate Sustained-Release 50 mg Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 682 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Evaluate The Efficacy And Safety Of 2 Fixed Doses (10 And 50 mg/Day) Of DVS SR Tablets In Adult Outpatients With Major Depressive Disorder
Study Start Date : April 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Desvenlafaxine succinate sustained release 10 mg Drug: Desvenlafaxine Succinate Sustained-Release 10mg
10 mg tablet, once daily dosing for 8 weeks

Experimental: Desvenlafaxine succinate sustained release 50 mg Drug: Desvenlafaxine Succinate Sustained-Release 50 mg
50 mg tablet, once daily dosing for 8 weeks

Placebo Comparator: Placebo Drug: placebo
Matching placebo tablets (10 or 50mg). Daily dosing for 10 +/- 4 days during a placebo lead-in period, and then 8 weeks during the double-blind period.




Primary Outcome Measures :
  1. Change From Baseline in HAM-D17 Total Score at Final On-therapy (FOT) Evaluation (Week 8 or ET) [ Time Frame: Baseline and Week 8 (or ET) ]
    HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.


Secondary Outcome Measures :
  1. Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (Week 8 or ET) [ Time Frame: Week 8 (or ET) ]
    CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.

  2. Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET) [ Time Frame: Baseline and Week 8 (or ET ) ]
    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.

  3. Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET) [ Time Frame: Baseline and Week 8 (or ET) ]
    MADRS 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).

  4. Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET) [ Time Frame: Baseline and Week 8 (or ET ) ]
    HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. 0=none/absent and 22=most severe.The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 and all others are scored 0-4.

  5. Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET) [ Time Frame: Week 8 (or ET) ]
    A HAM-D17 responder was defined as a participant with a 50% or greater decrease from baseline in HAM-D17 score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.

  6. Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET) [ Time Frame: Week 8 (or ET) ]
    Remission was defined as a HAM-D17 score of less than or equal to 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.

  7. Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET) [ Time Frame: Week 8 (or ET) ]
    A MADRS responder was defined as a participant with a 50% or greater decrease from baseline in MADRS score. It 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).

  8. Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET) [ Time Frame: Week 8 (or ET) ]
    CGI-I responder was defined as a participant with a score of 1 (very much improved) or 2 (much improved) on the CGI-I. CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive symptoms for at least 30 days prior to screening).
  • Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of >= 20.
  • Clinical Global Impressions Scale-Severity (CGI-S) score of >= 4.

Exclusion Criteria:

  • Clinical instability (25% or greater increase/decrease in HAM-D 17 total score from screening to baseline).
  • Significant risk of suicide as assessed by clinician judgment, HAM-D 17 and Columbia Suicide-Severity Rating Scale scores Other eligibility criteria also apply.

Information from the National Library of Medicine

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): NCT00863798


Locations
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United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35216
United States, California
Pfizer Investigational Site
Encino, California, United States, 91316
Pfizer Investigational Site
Newport Beach, California, United States, 92660
Pfizer Investigational Site
Redlands, California, United States, 92374
Pfizer Investigational Site
Upland, California, United States, 91786
United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80045
Pfizer Investigational Site
Denver, Colorado, United States, 80204
United States, Connecticut
Pfizer Investigational Site
Cromwell, Connecticut, United States, 06416
United States, Florida
Pfizer Investigational Site
Maitland, Florida, United States, 32751
Pfizer Investigational Site
North Miami, Florida, United States, 33161
Pfizer Investigational Site
South Miami, Florida, United States, 33143
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46260
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63139
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10128
Pfizer Investigational Site
Staten Island, New York, United States, 10312
United States, Ohio
Pfizer Investigational Site
Toledo, Ohio, United States, 43623
United States, Oregon
Pfizer Investigational Site
Eugene, Oregon, United States, 97401
Pfizer Investigational Site
Portland, Oregon, United States, 97210
Pfizer Investigational Site
Salem, Oregon, United States, 97301
United States, Pennsylvania
Pfizer Investigational Site
Media, Pennsylvania, United States, 19063
United States, Virginia
Pfizer Investigational Site
Herndon, Virginia, United States, 20170
Pfizer Investigational Site
Midlothian, Virginia, United States, 23112
United States, Wisconsin
Pfizer Investigational Site
Middleton, Wisconsin, United States, 53562
Pfizer Investigational Site
Waukesha, Wisconsin, United States, 53188
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Director, Clinical Trial Disclosure Group, Wyeth
ClinicalTrials.gov Identifier: NCT00863798     History of Changes
Other Study ID Numbers: 3151A1-3362
B2061005
3151A1-3362-US
First Posted: March 18, 2009    Key Record Dates
Results First Posted: May 6, 2011
Last Update Posted: May 6, 2011
Last Verified: April 2011
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Major Depressive Disorder
Additional relevant MeSH terms:
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Desvenlafaxine Succinate
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs