Major Depressive Disorder Clinical Trial
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
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.
Status | Completed |
Enrollment | 682 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Pfizer Investigational Site | Aurora | Colorado |
United States | Pfizer Investigational Site | Birmingham | Alabama |
United States | Pfizer Investigational Site | Cromwell | Connecticut |
United States | Pfizer Investigational Site | Denver | Colorado |
United States | Pfizer Investigational Site | Encino | California |
United States | Pfizer Investigational Site | Eugene | Oregon |
United States | Pfizer Investigational Site | Herndon | Virginia |
United States | Pfizer Investigational Site | Indianapolis | Indiana |
United States | Pfizer Investigational Site | Maitland | Florida |
United States | Pfizer Investigational Site | Media | Pennsylvania |
United States | Pfizer Investigational Site | Middleton | Wisconsin |
United States | Pfizer Investigational Site | Midlothian | Virginia |
United States | Pfizer Investigational Site | New York | New York |
United States | Pfizer Investigational Site | Newport Beach | California |
United States | Pfizer Investigational Site | North Miami | Florida |
United States | Pfizer Investigational Site | Portland | Oregon |
United States | Pfizer Investigational Site | Redlands | California |
United States | Pfizer Investigational Site | Salem | Oregon |
United States | Pfizer Investigational Site | South Miami | Florida |
United States | Pfizer Investigational Site | St. Louis | Missouri |
United States | Pfizer Investigational Site | Staten Island | New York |
United States | Pfizer Investigational Site | Toledo | Ohio |
United States | Pfizer Investigational Site | Upland | California |
United States | Pfizer Investigational Site | Waukesha | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Wyeth is now a wholly owned subsidiary of Pfizer | Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in HAM-D17 Total Score at Final On-therapy (FOT) Evaluation (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. | Baseline and Week 8 (or ET) | No |
Secondary | Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (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. | Week 8 (or ET) | No |
Secondary | Change From Baseline in Mean CGI-S Score at FOT Evaluation (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. | Baseline and Week 8 (or ET ) | No |
Secondary | Change From Baseline in MADRS Total Score at FOT Evaluation (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). | Baseline and Week 8 (or ET) | No |
Secondary | Change From Baseline in HAM-D6 Total Score at FOT Evaluation (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. | Baseline and Week 8 (or ET ) | No |
Secondary | Number of Participants With a Response on the HAM-D17 at FOT Evaluation (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. | Week 8 (or ET) | No |
Secondary | Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (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. | Week 8 (or ET) | No |
Secondary | Number of Participants With a Response on the MADRS Score at FOT Evaluation (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). | Week 8 (or ET) | No |
Secondary | Number of Participants With a Response on the CGI-I Score at FOT Evaluation (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. | Week 8 (or ET) | No |
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