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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

Tracking Information
First Submitted Date  ICMJE March 17, 2009
First Posted Date  ICMJE March 18, 2009
Results First Submitted Date  ICMJE March 8, 2011
Results First Posted Date  ICMJE May 6, 2011
Last Update Posted Date May 6, 2011
Study Start Date  ICMJE April 2009
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 17, 2009)
Change from baseline to the end of the double-blind phase on the Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score. [ Time Frame: Approximately 10 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 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. 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.
  • 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: March 17, 2009)
CGI- Severity rating. Total scores of MADRS, HAM-D 6-item, WHO-5, and Sheehan Disability Scale (total and subcomponent scores). Response rate to therapy, adverse events, and changes in sexual functioning. HAM-D17 remission rate. [ Time Frame: Approximately 10 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: April 7, 2011)
  • Population Pharmacokinetics for Desvenlafaxine Plasma Concentrations [ Time Frame: Week 2, 4 and 8 (or ET) ]
    Relationship of demographic variables (age, gender, food, race, creatinine, aspartate aminotransaminase, alanine transaminase, bilirubin and concomitant medications) were examined by fitting measured DVS plasma concentrations to a 1 compartment model with first order absorption. Demographic variables were examined for clearance (CL/F), volume of distribution (V/F), Steady Area under Curve (AUC) using nonlinear mixed effects modeling. Final parameter estimates for demographic factors effecting CL/F, V/F and AUC were determined.
  • Change From Baseline in SDS at FOT Evaluation (Week 8 or ET) [ Time Frame: Baseline and Week 8 (or ET) ]
    SDS: a self-administered tools that measures functional impairment in 3 domains: Work/School, Social Life, and Family Life/Home Responsibilities. The participant rates the extent to which each of these domains is impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired, 10=extremely impaired) for a total maximum score of 30.
  • Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET) [ Time Frame: Baseline and Week 8 (or ET) ]
    WHO-5 evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0= worst possible quality of life; 25=best possible quality of life).
  • Percentage of Participants With Sexual Dysfunction at FOT Evaluation (Week 8 or ET) [ Time Frame: Week 8 (or ET) ]
    ASEX scale includes 5 questions that evaluate sexual function exclusively during the week prior to completion in the following areas: libido, excitability and ability to reach orgasm. Sexual dysfunction=an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items. Participants who have had no sexual activity during the prior week were instructed to not complete questions 3 through 5.
  • Number of Participants With Categorical Scores on the C-SSRS at FOT Evaluation (Week 8 or ET) [ Time Frame: Week 8 (or ET) ]
    C-SSRS mapped into C-CASA(1-7) to assess whether participant:completed suicide(1),suicide attempt(2)(response of "Yes" on "Actual Attempt"),preparatory acts toward imminent suicidal behavior (3)("Yes" on "Preparatory Acts or Behavior"),suicidal ideation (4)("Yes" on "Wish to be dead","Non-Specific Active Suicidal Thoughts","Active Suicidal Ideation with methods without Intent to Act or Some Intent to Act,without Specific Plan or with Specific Plan and Intent),any suicidal behavior or ideation,self-injurious behaviour(7)("Yes" on "Has subject engaged in Non-suicidal Self-Injurious Behavior").
  • Discontinuation-Emergent Signs and Symptoms (DESS) [ Time Frame: Week 8 to 10 (or ET) ]
    DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms that appeared during tapering of the test article. A higher score indicates more symptoms.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Desvenlafaxine Succinate Sustained Release In Adults With 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 (10 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 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.
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 10mg
    10 mg tablet, once daily dosing for 8 weeks
  • Drug: Desvenlafaxine Succinate Sustained-Release 50 mg
    50 mg tablet, once daily dosing for 8 weeks
  • 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.
Study Arms  ICMJE
  • Experimental: Desvenlafaxine succinate sustained release 10 mg
    Intervention: Drug: Desvenlafaxine Succinate Sustained-Release 10mg
  • Experimental: Desvenlafaxine succinate sustained release 50 mg
    Intervention: Drug: Desvenlafaxine Succinate Sustained-Release 50 mg
  • 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)
682
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2009)
678
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 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 judgment, 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00863798
Other Study ID Numbers  ICMJE 3151A1-3362
B2061005
3151A1-3362-US
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, Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date April 2011

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