- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00863798
Study Evaluating Desvenlafaxine Succinate Sustained Release In Adults With Major Depressive Disorder
April 7, 2011 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
682
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35216
- Pfizer Investigational Site
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California
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Encino, California, United States, 91316
- Pfizer Investigational Site
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Newport Beach, California, United States, 92660
- Pfizer Investigational Site
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Redlands, California, United States, 92374
- Pfizer Investigational Site
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Upland, California, United States, 91786
- Pfizer Investigational Site
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Colorado
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Aurora, Colorado, United States, 80045
- Pfizer Investigational Site
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Denver, Colorado, United States, 80204
- Pfizer Investigational Site
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Connecticut
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Cromwell, Connecticut, United States, 06416
- Pfizer Investigational Site
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Florida
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Maitland, Florida, United States, 32751
- Pfizer Investigational Site
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North Miami, Florida, United States, 33161
- Pfizer Investigational Site
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South Miami, Florida, United States, 33143
- Pfizer Investigational Site
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Indiana
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Indianapolis, Indiana, United States, 46260
- Pfizer Investigational Site
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Missouri
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St. Louis, Missouri, United States, 63139
- Pfizer Investigational Site
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New York
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New York, New York, United States, 10128
- Pfizer Investigational Site
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Staten Island, New York, United States, 10312
- Pfizer Investigational Site
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Ohio
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Toledo, Ohio, United States, 43623
- Pfizer Investigational Site
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Oregon
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Eugene, Oregon, United States, 97401
- Pfizer Investigational Site
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Portland, Oregon, United States, 97210
- Pfizer Investigational Site
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Salem, Oregon, United States, 97301
- Pfizer Investigational Site
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Pennsylvania
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Media, Pennsylvania, United States, 19063
- Pfizer Investigational Site
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Virginia
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Herndon, Virginia, United States, 20170
- Pfizer Investigational Site
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Midlothian, Virginia, United States, 23112
- Pfizer Investigational Site
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Wisconsin
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Middleton, Wisconsin, United States, 53562
- Pfizer Investigational Site
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Waukesha, Wisconsin, United States, 53188
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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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.
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Experimental: Desvenlafaxine succinate sustained release 50 mg
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50 mg tablet, once daily dosing for 8 weeks
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Experimental: Desvenlafaxine succinate sustained release 10 mg
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10 mg tablet, once daily dosing for 8 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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.
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Baseline and Week 8 (or ET)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)
Time Frame: Week 8 (or ET)
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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.
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Week 8 (or ET)
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Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)
Time Frame: Baseline and Week 8 (or ET)
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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).
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Baseline and Week 8 (or ET)
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Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)
Time Frame: Week 8 (or ET)
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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.
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Week 8 (or ET)
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Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)
Time Frame: Week 8 (or ET)
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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.
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Week 8 (or ET)
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Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)
Time Frame: Week 8 (or ET)
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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).
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Week 8 (or ET)
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Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)
Time Frame: Week 8 (or ET)
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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.
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Week 8 (or ET)
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Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET)
Time Frame: Baseline and Week 8 (or ET )
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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.
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Baseline and Week 8 (or ET )
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Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)
Time Frame: Baseline and Week 8 (or ET )
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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.
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Baseline and Week 8 (or ET )
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Population Pharmacokinetics for Desvenlafaxine Plasma Concentrations
Time Frame: Week 2, 4 and 8 (or ET)
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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.
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Week 2, 4 and 8 (or ET)
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Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET)
Time Frame: Baseline and Week 8 (or ET)
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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).
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Baseline and Week 8 (or ET)
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Number of Participants With Categorical Scores on the C-SSRS at FOT Evaluation (Week 8 or ET)
Time Frame: Week 8 (or ET)
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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").
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Week 8 (or ET)
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Change From Baseline in SDS at FOT Evaluation (Week 8 or ET)
Time Frame: Baseline and Week 8 (or ET)
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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.
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Baseline and Week 8 (or ET)
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Percentage of Participants With Sexual Dysfunction at FOT Evaluation (Week 8 or ET)
Time Frame: Week 8 (or ET)
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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.
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Week 8 (or ET)
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Discontinuation-Emergent Signs and Symptoms (DESS)
Time Frame: Week 8 to 10 (or ET)
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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.
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Week 8 to 10 (or ET)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
March 17, 2009
First Submitted That Met QC Criteria
March 17, 2009
First Posted (Estimate)
March 18, 2009
Study Record Updates
Last Update Posted (Estimate)
May 6, 2011
Last Update Submitted That Met QC Criteria
April 7, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Mood Disorders
- Depression
- Depressive Disorder
- Disease
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Serotonin and Noradrenaline Reuptake Inhibitors
- Desvenlafaxine Succinate
Other Study ID Numbers
- 3151A1-3362
- B2061005
- 3151A1-3362-US
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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