Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00824291
Previous Study | Return to List | Next Study

Study Evaluating Desvenlafaxine Succinate Sustained Release In Outpatients 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: NCT00824291
Recruitment Status : Completed
First Posted : January 16, 2009
Results First Posted : November 25, 2010
Last Update Posted : March 10, 2011
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE January 14, 2009
First Posted Date  ICMJE January 16, 2009
Results First Submitted Date  ICMJE October 26, 2010
Results First Posted Date  ICMJE November 25, 2010
Last Update Posted Date March 10, 2011
Study Start Date  ICMJE February 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2010)
Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12 [ Time Frame: At Baseline and Week 12. ]
HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss). Total score ranges from 0 to 52; higher scores indicate more depression. Change from baseline: mean at observation minus mean at baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2009)
Change in HAM-D17 score from baseline after 12 weeks [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT00824291 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2010)
  • Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 12 [ Time Frame: At Baseline and Week 12. ]
    Participant rated scale was used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Individual item scores range from 0 to 10.
  • Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12 [ Time Frame: At Baseline and Week 12. ]
    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 = score at observation minus score at baseline.
  • Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12 [ Time Frame: At Baseline and Week 12. ]
    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.
  • Change From Baseline on Work and Activities Item of HAM-D17 at Week 12 [ Time Frame: At Baseline and Week 12. ]
    The Work and Activities Item of the HAM-D17 is item 7 of HAM-D17. Scoring range from 0 to 4.
  • Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 12 [ Time Frame: At Baseline and Week 12. ]
    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 on Worry Anxiety Tension Scale (WATS) at Week 12 [ Time Frame: At Baseline and Week 12. ]
    WATS: a self-administered, 3-question rating scale assesses worry, anxiety, and tension. Each item was a visual analog scale on which the participant circles a number from 0 to 10. Higher scores indicated worse function. WATS total score was the sum of the 3 items. If 1 item was missing, the total score would be missing.
  • Change From Baseline on Stress and Social Support Scales at Week 12 [ Time Frame: At Baseline and Week 12. ]
    Stress and Social Support Scales: self-administered rating scale where item 1 is the stress vulnerability scale measuring how much the subject was set back by stressful events on an 11-point scale ranging from 0 (not at all) to 10 (extremely) and item 2 is an 11-point scale ranging from 0 to 100 percent of the amount of support the subject received from relatives and friends.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2009)
To compare DVS SR to placebo on Sheehan Disability Scale. [ Time Frame: 12 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 In Outpatients With Major Depressive Disorder
Official Title  ICMJE A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study To Evaluate Functional Outcome In Outpatients With Major Depressive Disorder Treated With Desvenlafaxine Succinare Sustained Release
Brief Summary This is a multicenter study to assess the health and well-being in subjects who are outpatients with major depressive disorder that take desvenlafaxine succinate sustained release (DVS SR) or placebo for 12 weeks.
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 Depressive Disorder, Major
Intervention  ICMJE
  • Drug: desvenlafaxine succinate sustained release
    50 mg/day oral tablet for 12 weeks
    Other Name: Pristiq
  • Genetic: Genotyping
    CYP2D6 genotyping at randomization
Study Arms  ICMJE
  • Placebo Comparator: 1
    Intervention: Drug: desvenlafaxine succinate sustained release
  • Experimental: 2
    Intervention: Genetic: Genotyping
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: November 30, 2010)
437
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2009)
400
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Outpatient men and women, between the ages of 18 to 75 years, fluent in both written and spoken English.
  • Employed for 20 hours or more for a minimum of 1 month prior to baseline.
  • Primary diagnosis of Major Depressive Disorder with symptoms for at least 30 days prior to baseline.

Exclusion Criteria:

  • Treatment with desvenlafaxine succinate sustained release at any time in the past and/or venlafaxine (Effexor or Effexor XR) 1 year prior to baseline.
  • Treatment-resistant defined as any of the following failed treatments in the past 3 years: 3 or more previous adequate trials of >=2 classes of antidepressant medication, electroconvulsive therapy, or psychotherapy (2 adequate trials).
  • Current (within 12 months prior to the screening visit) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
  • Clinically important abnormalities on physical examination, electrocardiogram (ECG), or laboratory evaluations.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 74 Years   (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 Not Provided
Removed Location Countries Canada,   United States
 
Administrative Information
NCT Number  ICMJE NCT00824291
Other Study ID Numbers  ICMJE 3151A1-4415
B2061006
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 Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date March 2011

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