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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: NCT00384033
Recruitment Status : Completed
First Posted : October 4, 2006
Results First Posted : March 15, 2012
Last Update Posted : March 15, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE October 2, 2006
First Posted Date  ICMJE October 4, 2006
Results First Submitted Date  ICMJE February 9, 2012
Results First Posted Date  ICMJE March 15, 2012
Last Update Posted Date March 15, 2012
Study Start Date  ICMJE September 2006
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2012)
Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation [ Time Frame: Baseline and Week 8 or FOT ]
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: October 2, 2006)
The primary study objective is to investigate DVS SR at doses of 50 and 100 mg to evaluate efficacy, safety and tolerability at the lower dose range.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2012)
  • Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation [ Time Frame: Week 8 or FOT ]
    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 relative to the baseline assessment. Higher score = more affected.
  • Change From Baseline in Mean CGI-S Score at Week 8 or FOT Evaluation [ Time Frame: Baseline and Week 8 or FOT ]
    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 participants). Higher score = more affected.
  • Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or FOT Evaluation [ Time Frame: Baseline and Week 8 or FOT ]
    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 the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation [ Time Frame: Baseline and Week 8 or FOT ]
    Lassitude item of MADRS represents a difficulty in getting started or slowness in initiating and performing everyday activities. It is rated on a scale of 0-6: 0 = hardly any difficulty in getting started/no sluggishness; 2 = difficulties in starting activities; 4 = difficulties in starting simple routine activities which are carried out with effort; 6 = complete lassitude/unable to do anything without help.
  • Change From Baseline in HAM-D6 Total Score at Week 8 or FOT Evaluation [ Time Frame: Baseline and Week 8 or FOT ]
    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 (0=none and 2=severe) and all others are scored 0-4 (0=none/absent and 4=most severe).
  • Change From Baseline in the HAM-D Energy Subscale Score at Week 8 or FOT Evaluation [ Time Frame: Baseline and Week 8 or FOT ]
    HAM-D energy subscale is a subset of the HAM-D17 that assesses 4 items associated with major depression. The scale uses HAM- D17 items 1, 7, 8 and 14. Item 14 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe).
  • Change From Baseline in Covi Anxiety Scale at Week 8 or FOT Evaluation [ Time Frame: Baseline and Week 8 or FOT ]
    COVI anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, to 5 = Very much. Worst value is 15 and best value is 3.
  • Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation [ Time Frame: Baseline and Week 8 or FOT ]
    VAS-PI scale assesses intensity of back pain, chest pain, arms, legs or joint pain as well as overall pain intensity where 100 mm line (VAS) is marked by participant and intensity of pain ranges from 0 millimetre (mm) = no pain to 100 mm = worst possible pain. There were separate 0 to 100 mm VAS lines for each subcomponent of VAS-PI.
Original Secondary Outcome Measures  ICMJE Not Provided
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, Duloxetine-Referenced, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (50mg, 100mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder
Brief Summary The primary purpose of this study is to evaluate the efficacy and safety of two doses of DVS SR (50 and 100 mg/day) in the treatment of adults with Major Depressive Disorder.
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 (DVS SR)
    50 mg tablet, once daily dosing for 8 weeks
  • Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
    100 mg tablet, once daily dosing for 8 weeks
  • Drug: Placebo
    Matching placebo tablets and capsules, once daily dosing for 8 weeks
  • Drug: Duloxetine 60 mg/day
    60 mg capsule, once daily dosing for 8 weeks
Study Arms  ICMJE
  • Experimental: Desvenlafaxine succinate sustained-release 50 mg
    Intervention: Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
  • Experimental: Desvenlafaxine succinate sustained-release 100 mg
    Intervention: Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Duloxetine 60mg
    Active control to assess assay sensitivity
    Intervention: Drug: Duloxetine 60 mg/day
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: September 6, 2011)
638
Original Enrollment  ICMJE
 (submitted: October 2, 2006)
640
Actual Study Completion Date  ICMJE September 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • A primary diagnosis of Major Depressive Disorder, single or recurrent episode, without psychotic features.
  • Depressive symptoms for at least 30 days before the screening visit.
  • Outpatient men and women at least 18 years of age.

Exclusion Criteria:

  • Significant risk of suicide based on clinical judgment, including common suicidal thoughts and suicide having been considered as a possible solution even without specific plans or intent.
  • Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation.
  • Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder; b) current (within 12 months before baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder; c) presence (within 12 months before baseline) of a clinically important personality disorder as assessed during the psychiatric assessments.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
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 NCT00384033
Other Study ID Numbers  ICMJE 3151A1-335
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2012

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