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Study Evaluating Desvenlafaxine Succinate Sustained Release In Adults With Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Desvenlafaxine Succinate Sustained-Release 10mg
Desvenlafaxine Succinate Sustained-Release 50 mg
placebo
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Desvenlafaxine succinate sustained release 10 mg

Desvenlafaxine succinate sustained release 50 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in HAM-D17 Total Score at Final On-therapy (FOT) Evaluation (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.

Secondary Outcome Measures

Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (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)
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)
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)
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)
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)
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)
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)
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.

Full Information

First Posted
March 17, 2009
Last Updated
April 7, 2011
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00863798
Brief Title
Study Evaluating Desvenlafaxine Succinate Sustained Release In Adults With Major Depressive Disorder
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
682 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Desvenlafaxine succinate sustained release 10 mg
Arm Type
Experimental
Arm Title
Desvenlafaxine succinate sustained release 50 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Desvenlafaxine Succinate Sustained-Release 10mg
Intervention Description
10 mg tablet, once daily dosing for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Desvenlafaxine Succinate Sustained-Release 50 mg
Intervention Description
50 mg tablet, once daily dosing for 8 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in HAM-D17 Total Score at Final On-therapy (FOT) Evaluation (Week 8 or ET)
Description
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.
Time Frame
Baseline and Week 8 (or ET)
Secondary Outcome Measure Information:
Title
Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)
Description
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.
Time Frame
Week 8 (or ET)
Title
Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET)
Description
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.
Time Frame
Baseline and Week 8 (or ET )
Title
Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)
Description
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).
Time Frame
Baseline and Week 8 (or ET)
Title
Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)
Description
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.
Time Frame
Baseline and Week 8 (or ET )
Title
Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)
Description
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.
Time Frame
Week 8 (or ET)
Title
Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)
Description
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.
Time Frame
Week 8 (or ET)
Title
Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)
Description
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).
Time Frame
Week 8 (or ET)
Title
Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)
Description
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.
Time Frame
Week 8 (or ET)
Other Pre-specified Outcome Measures:
Title
Population Pharmacokinetics for Desvenlafaxine Plasma Concentrations
Description
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.
Time Frame
Week 2, 4 and 8 (or ET)
Title
Change From Baseline in SDS at FOT Evaluation (Week 8 or ET)
Description
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.
Time Frame
Baseline and Week 8 (or ET)
Title
Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET)
Description
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).
Time Frame
Baseline and Week 8 (or ET)
Title
Percentage of Participants With Sexual Dysfunction at FOT Evaluation (Week 8 or ET)
Description
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.
Time Frame
Week 8 (or ET)
Title
Number of Participants With Categorical Scores on the C-SSRS at FOT Evaluation (Week 8 or ET)
Description
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").
Time Frame
Week 8 (or ET)
Title
Discontinuation-Emergent Signs and Symptoms (DESS)
Description
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.
Time Frame
Week 8 to 10 (or ET)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Pfizer Investigational Site
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Pfizer Investigational Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Pfizer Investigational Site
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Pfizer Investigational Site
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Pfizer Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Pfizer Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Pfizer Investigational Site
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Pfizer Investigational Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Pfizer Investigational Site
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Pfizer Investigational Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Pfizer Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63139
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Pfizer Investigational Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Pfizer Investigational Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Pfizer Investigational Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Pfizer Investigational Site
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Pfizer Investigational Site
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Pfizer Investigational Site
City
Herndon
State/Province
Virginia
ZIP/Postal Code
20170
Country
United States
Facility Name
Pfizer Investigational Site
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23112
Country
United States
Facility Name
Pfizer Investigational Site
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
Facility Name
Pfizer Investigational Site
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34183490
Citation
Zilcha-Mano S, Wang X, Wajsbrot DB, Boucher M, Fine SA, Rutherford BR. Trajectories of Function and Symptom Change in Desvenlafaxine Clinical Trials: Toward Personalized Treatment for Depression. J Clin Psychopharmacol. 2021 Sep-Oct 01;41(5):579-584. doi: 10.1097/JCP.0000000000001435.
Results Reference
derived
PubMed Identifier
29140227
Citation
Soares CN, Zhang M, Boucher M. Categorical improvement in functional impairment in depressed patients treated with desvenlafaxine. CNS Spectr. 2019 Jun;24(3):322-332. doi: 10.1017/S1092852917000633. Epub 2017 Nov 15.
Results Reference
derived
PubMed Identifier
26709542
Citation
McIntyre RS, Fayyad R, Mackell JA, Boucher M. Effect of metabolic syndrome and thyroid hormone on efficacy of desvenlafaxine 50 and 100 mg/d in major depressive disorder. Curr Med Res Opin. 2016;32(3):587-99. doi: 10.1185/03007995.2015.1136603. Epub 2016 Jan 13.
Results Reference
derived
PubMed Identifier
26644956
Citation
McIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. A Post Hoc Analysis of the Effect of Weight on Efficacy in Depressed Patients Treated With Desvenlafaxine 50 mg/d and 100 mg/d. Prim Care Companion CNS Disord. 2015 Jun 4;17(3):10.4088/PCC.14m01741. doi: 10.4088/PCC.14m01741. eCollection 2015.
Results Reference
derived
PubMed Identifier
25758058
Citation
Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26.
Results Reference
derived
PubMed Identifier
24571916
Citation
Soares CN, Endicott J, Boucher M, Fayyad RS, Guico-Pabia CJ. Predictors of functional response and remission with desvenlafaxine 50 mg/d in patients with major depressive disorder. CNS Spectr. 2014 Dec;19(6):519-27. doi: 10.1017/S1092852914000066. Epub 2014 Feb 26.
Results Reference
derived
PubMed Identifier
23517291
Citation
Liebowitz MR, Tourian KA, Hwang E, Mele L; Study 3362 Investigators. A double-blind, randomized, placebo-controlled study assessing the efficacy and tolerability of desvenlafaxine 10 and 50 mg/day in adult outpatients with major depressive disorder. BMC Psychiatry. 2013 Mar 22;13:94. doi: 10.1186/1471-244X-13-94.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3151A1-3362&StudyName=Study%20Evaluating%20Desvenlafaxine%20Succinate%20Sustained%20Release%20In%20Adults%20With%20Major%20Depressive%20Disorder
Description
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Study Evaluating Desvenlafaxine Succinate Sustained Release In Adults With Major Depressive Disorder

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