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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

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.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR) Drug: Placebo Drug: Duloxetine 60 mg/day Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 638 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Desvenlafaxine succinate sustained-release 50 mg Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
50 mg tablet, once daily dosing for 8 weeks

Experimental: Desvenlafaxine succinate sustained-release 100 mg Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
100 mg tablet, once daily dosing for 8 weeks

Placebo Comparator: Placebo Drug: Placebo
Matching placebo tablets and capsules, once daily dosing for 8 weeks

Duloxetine 60mg
Active control to assess assay sensitivity
Drug: Duloxetine 60 mg/day
60 mg capsule, once daily dosing for 8 weeks




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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).

  6. 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).

  7. 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.

  8. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384033


Locations
United States, California
Pfizer Investigational Site
Beverly Hills, California, United States, 90210
Pfizer Investigational Site
Burbank, California, United States, 91506
Pfizer Investigational Site
Encino, California, United States, 91316
Pfizer Investigational Site
Los Alamitos, California, United States, 90720
Pfizer Investigational Site
Newport Beach, California, United States, 92660
Pfizer Investigational Site
Northridge, California, United States, 91324
Pfizer Investigational Site
Orange, California, United States, 92868
Pfizer Investigational Site
Pasadena, California, United States, 91105
Pfizer Investigational Site
Upland, California, United States, 91786
United States, Florida
Pfizer Investigational Site
South Miami, Florida, United States, 33143
Pfizer Investigational Site
St. Petersburg, Florida, United States, 33702
United States, Illinois
Pfizer Investigational Site
Edwardsville, Illinois, United States, 62025
United States, Michigan
Pfizer Investigational Site
Farmington Hills, Michigan, United States, 48336
Pfizer Investigational Site
Flint, Michigan, United States, 48507
Pfizer Investigational Site
Okemos, Michigan, United States, 48864
United States, New Jersey
Pfizer Investigational Site
Clementon, New Jersey, United States, 08021
United States, Ohio
Pfizer Investigational Site
Dayton, Ohio, United States, 45408
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19149
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84107
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98104
United States, Wisconsin
Pfizer Investigational Site
Brown Deer, Wisconsin, United States, 53223
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00384033     History of Changes
Other Study ID Numbers: 3151A1-335
First Posted: October 4, 2006    Key Record Dates
Results First Posted: March 15, 2012
Last Update Posted: March 15, 2012
Last Verified: February 2012

Keywords provided by Pfizer:
MDD
Major Depressive Disorder
Depression

Additional relevant MeSH terms:
Depressive Disorder, Major
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Depressive Disorder
Depression
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Duloxetine Hydrochloride
Desvenlafaxine Succinate
Serotonin and Noradrenaline Reuptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents