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Trial record 65 of 89 for:    DESVENLAFAXINE

Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD

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: NCT00445679
Recruitment Status : Completed
First Posted : March 9, 2007
Results First Posted : November 4, 2013
Last Update Posted : November 4, 2013
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE March 6, 2007
First Posted Date  ICMJE March 9, 2007
Results First Submitted Date  ICMJE February 26, 2010
Results First Posted Date  ICMJE November 4, 2013
Last Update Posted Date November 4, 2013
Study Start Date  ICMJE July 2007
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2013)
Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17) [ Time Frame: 8 weeks ]
HAM-D17 is 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 8, 2007)
The primary efficacy outcome measure will be the mean total score of the 17-item Hamilton Depression Scale (HAM-D17).
Change History Complete list of historical versions of study NCT00445679 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2013)
  • Clinical Global Impressions Scale-Improvement (CGI-I) Scores [ Time Frame: 8 weeks ]
    CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the subject's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).
  • Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores [ Time Frame: 8 weeks ]
    CGI-S is a global rating scale that measures the severity of a subject's disease. Using a 7-point scale, the clinician rates the severity of the patient's mental illness at the time of the assessment, relative to the clinician's experience with subjects who have the same diagnosis (1= normal, not at all ill; 7= among the most extremely ill).
  • Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline [ Time Frame: Baseline and 8 weeks ]
    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).
  • Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline [ Time Frame: 8 weeks ]
    The VAS-PI is a self-rated visual analog scale for the assessment of pain. Scores on the VAS-PI range from 0 (no pain) to 10 (worst possible pain). A decrease in VAS-PI overall scores indicates a subject's assessment of an improvement in pain.
  • Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline [ Time Frame: 8 weeks ]
    HAM-D6: standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 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). Total score ranges from 0 to 22; higher score indicates more depression.
  • Covi Anxiety Scale Score Mean Change From Baseline [ Time Frame: 8 weeks ]
    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, 5 = Very much. Total score ranges from 3 to 15; higher score indicates more anxiety.
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 Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD
Official Title  ICMJE A Multicenter, Randomized, Double-blind, Paroxetine-referenced, Parallel-group Study to Evaluate the Safety, Efficacy, and Tolerability of 3 Fixed Doses (50mg, 100mg, AND 200mg) of Desvenlafaxine Succinate Sustained-release Tablets in Adult Outpatients With Major Depressive Disorder
Brief Summary This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate sustained release (DVS SR) in subjects with major depressive disorder.
Detailed Description The primary objective of this study is to investigate the efficacy, safety and tolerability of desvenlafaxine succinate sustained release (DVS SR) in Chinese, Taiwanese, South Korean, and Indian subjects with major depressive disorder (MDD) receiving daily doses of 50 mg, 100 mg, or 200 mg. The secondary objective is to obtain additional information regarding the efficacy of DVS SR in subjects with MDD receiving daily doses of 50 mg, 100 mg, or 200 mg. Additional objectives include obtaining general and functional quality of life outcome data.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Major
Intervention  ICMJE
  • Drug: DVS SR
    Arm 1: 50mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 2: 100mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 3: 200mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper
  • Drug: Paroxetine
    20 mg Paroxetine capsule, QD, 8 weeks treatment with 2 week taper
Study Arms  ICMJE
  • Experimental: A
    DVS SR 50mg/day
    Intervention: Drug: DVS SR
  • Experimental: B
    DVS SR 100mg/day
    Intervention: Drug: DVS SR
  • Experimental: C
    DVS SR 200mg/day
    Intervention: Drug: DVS SR
  • Active Comparator: D
    Paroxetine 20mg/day
    Intervention: Drug: Paroxetine
Publications * Not Provided

*   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: October 8, 2013)
807
Original Enrollment  ICMJE
 (submitted: March 8, 2007)
915
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Primary Inclusion Criteria:

  1. Outpatient men and women at least 18 years of age.
  2. Have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV), single or recurrent episode, without psychotic features.
  3. Have a HAM D17 total score ≥20 at the screening and baseline (study day 1) visit.

Primary Exclusion Criteria:

  1. Treatment with DVS SR at any time in the past.
  2. 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.
  3. 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.
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 China,   India,   Korea, Republic of,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00445679
Other Study ID Numbers  ICMJE 3151A1-336
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For China: medinfo@wyeth.com
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date October 2013

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