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

Primary Purpose

Depressive Disorder, Major

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
desvenlafaxine succinate sustained release
Genotyping
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 Depressive Disorder, Major focused on measuring Major Depressive Disorder

Eligibility Criteria

19 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    1

    2

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Hamilton Depression Scale (HAM-D) at 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.

    Secondary Outcome Measures

    Change From Baseline in Sheehan Disability Scale (SDS) Total Score at 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
    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
    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
    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
    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
    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
    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.

    Full Information

    First Posted
    January 14, 2009
    Last Updated
    March 4, 2011
    Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00824291
    Brief Title
    Study Evaluating Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder
    Official Title
    A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study To Evaluate Functional Outcome In Outpatients With Major Depressive Disorder Treated With Desvenlafaxine Succinare Sustained Release
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2009 (undefined)
    Primary Completion Date
    October 2009 (Actual)
    Study Completion Date
    November 2009 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depressive Disorder, Major
    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
    437 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Placebo Comparator
    Arm Title
    2
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    desvenlafaxine succinate sustained release
    Other Intervention Name(s)
    Pristiq
    Intervention Description
    50 mg/day oral tablet for 12 weeks
    Intervention Type
    Genetic
    Intervention Name(s)
    Genotyping
    Intervention Description
    CYP2D6 genotyping at randomization
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12
    Description
    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.
    Time Frame
    At Baseline and Week 12.
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 12
    Description
    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.
    Time Frame
    At Baseline and Week 12.
    Title
    Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12
    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. Change = score at observation minus score at baseline.
    Time Frame
    At Baseline and Week 12.
    Title
    Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12
    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. Change: score at observation minus score at baseline.
    Time Frame
    At Baseline and Week 12.
    Title
    Change From Baseline on Work and Activities Item of HAM-D17 at Week 12
    Description
    The Work and Activities Item of the HAM-D17 is item 7 of HAM-D17. Scoring range from 0 to 4.
    Time Frame
    At Baseline and Week 12.
    Title
    Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 12
    Description
    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
    At Baseline and Week 12.
    Title
    Change From Baseline on Worry Anxiety Tension Scale (WATS) at Week 12
    Description
    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.
    Time Frame
    At Baseline and Week 12.
    Title
    Change From Baseline on Stress and Social Support Scales at Week 12
    Description
    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.
    Time Frame
    At Baseline and Week 12.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    74 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    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
    27009044
    Citation
    Reddy S, Fayyad R, Edgar CJ, Guico-Pabia CJ, Wesnes K. The effect of desvenlafaxine on cognitive functioning in employed outpatients with major depressive disorder: a substudy of a randomized, double-blind, placebo-controlled trial. J Psychopharmacol. 2016 Jun;30(6):559-67. doi: 10.1177/0269881116631649. Epub 2016 Mar 23.
    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
    25012446
    Citation
    Endicott J, Lam RW, Hsu MA, Fayyad R, Boucher M, Guico-Pabia CJ. Improvements in quality of life with desvenlafaxine 50mg/d vs placebo in employed adults with major depressive disorder. J Affect Disord. 2014 Sep;166:307-14. doi: 10.1016/j.jad.2014.05.011. Epub 2014 May 21.
    Results Reference
    derived
    PubMed Identifier
    24583567
    Citation
    Lam RW, Endicott J, Hsu MA, Fayyad R, Guico-Pabia C, Boucher M. Predictors of functional improvement in employed adults with major depressive disorder treated with desvenlafaxine. Int Clin Psychopharmacol. 2014 Sep;29(5):239-51. doi: 10.1097/YIC.0000000000000031.
    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
    Links:
    URL
    https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3151A1-4415&StudyName=Study%20Evaluating%20Desvenlafaxine%20Succinate%20Sustained%20Release%20In%20Outpatients%20With%20Major%20Depressive%20Disorder
    Description
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