Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder

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

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.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR); Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR); Drug: Placebo; Drug: Duloxetine 60 mg/day

• Study Type: Interventional
• Enrollment (Actual): 638
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • 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
      • Pfizer Investigational Site
  • Florida
    • South Miami, Florida, United States, 33143
      • Pfizer Investigational Site
    • St. Petersburg, Florida, United States, 33702
      • Pfizer Investigational Site
  • Illinois
    • Edwardsville, Illinois, United States, 62025
      • Pfizer Investigational Site
  • Michigan
    • Farmington Hills, Michigan, United States, 48336
      • Pfizer Investigational Site
    • Flint, Michigan, United States, 48507
      • Pfizer Investigational Site
    • Okemos, Michigan, United States, 48864
      • Pfizer Investigational Site
  • New Jersey
    • Clementon, New Jersey, United States, 08021
      • Pfizer Investigational Site
  • Ohio
    • Dayton, Ohio, United States, 45408
      • Pfizer Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97210
      • Pfizer Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19149
      • Pfizer Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Pfizer Investigational Site
  • Washington
    • Seattle, Washington, United States, 98104
      • Pfizer Investigational Site
  • Wisconsin
    • Brown Deer, Wisconsin, United States, 53223
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matching placebo tablets and capsules, once daily dosing for 8 weeks
Experimental: Desvenlafaxine succinate sustained-release 50 mg	Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR); 50 mg tablet, once daily dosing for 8 weeks; Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR); 100 mg tablet, once daily dosing for 8 weeks
Experimental: Desvenlafaxine succinate sustained-release 100 mg	Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR); 50 mg tablet, once daily dosing for 8 weeks; Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR); 100 mg tablet, once daily dosing for 8 weeks
Other: Duloxetine 60mg; Active control to assess assay sensitivity	Drug: Duloxetine 60 mg/day; 60 mg capsule, once daily dosing for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation	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.	Baseline and Week 8 or FOT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation	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.	Week 8 or FOT
Change From Baseline in Mean CGI-S Score at Week 8 or FOT Evaluation	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.	Baseline and Week 8 or FOT
Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or FOT Evaluation	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).	Baseline and Week 8 or FOT
Change From Baseline in the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation	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.	Baseline and Week 8 or FOT
Change From Baseline in HAM-D6 Total Score at Week 8 or FOT Evaluation	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).	Baseline and Week 8 or FOT
Change From Baseline in the HAM-D Energy Subscale Score at Week 8 or FOT Evaluation	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).	Baseline and Week 8 or FOT
Change From Baseline in Covi Anxiety Scale at Week 8 or FOT Evaluation	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.	Baseline and Week 8 or FOT
Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation	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.	Baseline and Week 8 or FOT

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

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.
• Tourian KA, Padmanabhan SK, Groark J, Brisard C, Farrington D. Desvenlafaxine 50 and 100 mg/d in the treatment of major depressive disorder: an 8-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial and a post hoc pooled analysis of three studies. Clin Ther. 2009 Jun;31 Pt 1:1405-23. doi: 10.1016/j.clinthera.2009.07.006.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: October 2, 2006
• First Submitted That Met QC Criteria: October 2, 2006
• First Posted (Estimate): October 4, 2006

Study Record Updates

• Last Update Posted (Estimate): March 15, 2012
• Last Update Submitted That Met QC Criteria: February 9, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Depression; MDD; Major Depressive Disorder
• 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; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Duloxetine Hydrochloride; Desvenlafaxine Succinate
• Other Study ID Numbers: 3151A1-335