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Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) in the Treatment of Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00798707
Recruitment Status : Completed
First Posted : November 26, 2008
Results First Posted : June 6, 2011
Last Update Posted : June 10, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE November 25, 2008
First Posted Date  ICMJE November 26, 2008
Results First Submitted Date  ICMJE March 7, 2011
Results First Posted Date  ICMJE June 6, 2011
Last Update Posted Date June 10, 2011
Study Start Date  ICMJE December 2008
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2011)
Change From Baseline in HAM-D17 Total Score at the 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 25, 2008)
Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) [ Time Frame: Approximately 10 weeks ]
Change History Complete list of historical versions of study NCT00798707 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2011)
  • 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.
  • 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.
  • 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).
  • 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. 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.
  • 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.
  • 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.
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2008)
Secondary efficacy outcome measures include the CGI-I and S, MADRS and HAM-D 6. Secondary safety outcome measures include AE, suicidality and discontinuation symptom monitoring, physical and vital signs, ECGs, and changes in sexual functioning. [ Time Frame: Approximately 10 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) in the Treatment of Major Depressive Disorder
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (25 and 50 mg/Day) of DVS SR Tablets in Adult Outpatients With Major Depressive Disorder
Brief Summary The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of DVS SR (25 and 50 mg/day) in the treatment of adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
    25 mg tablet, once daily dosing for 8 weeks
  • Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
    50 mg tablet, once daily dosing for 8 weeks
  • Drug: placebo
    Matching placebo tablets (25 or 50 mg). Daily dosing for 10 +/- 4 days during a placebo lead-in period, and then 8 weeks during the double-blind period.
Study Arms  ICMJE
  • Experimental: Desvenlafaxine succinate sustained-release 25 mg
    Intervention: Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
  • Experimental: Desvenlafaxine succinate sustained-release 50 mg
    Intervention: Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2010)
709
Original Estimated Enrollment  ICMJE
 (submitted: November 25, 2008)
678
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 judgement, HAM-D 17 and Columbia Suicide-Severity Rating Scale scores Other eligibility criteria also apply
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00798707
Other Study ID Numbers  ICMJE 3151A1-3359
B2061003
3151A1-3359-WW
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP