Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD)

A Phase IV, Multicenter, Randomized, 8-Week, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy of 2 Fixed Doses (50 and 100 mg/Day) of Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder

A multicenter, 8-week study to evaluate the efficacy of 2 doses (50 and 100 mg/day) of desvenlafaxine succinate sustained-release (DVS SR) versus placebo in adult outpatients with major depressive disorder.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: desvenlafaxine succinate sustained-release 50 mg/day; Drug: desvenlafaxine succinate sustained-release 100 mg/day; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 924
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85020
      • Dedicated Clinical Research
    • Phoenix, Arizona, United States, 85020
      • Deidcated Clinical Research
  • Arkansas
    • Little Rock, Arkansas, United States, 72223
      • Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
  • California
    • Arcadia, California, United States, 91007
      • Pacific Clinical Research Medical Group
    • Beverly Hills, California, United States, 90210
      • Southwestern Research, Incorporated
    • Costa Mesa, California, United States, 92626
      • Clinical Innovations, Inc.
    • Escondido, California, United States, 92027
      • Synergy Clinical Research of Escondido
    • National City, California, United States, 91950
      • Synergy Clinical Research Center
    • Oakland, California, United States, 94612
      • Pacific Research Partners
    • Pasadena, California, United States, 91106
      • Pasadena Research Institute, LLC
    • Riverside, California, United States, 92506
      • Clinical Innovations, Inc.
    • San Diego, California, United States, 92108
      • Affiliated Research Institute
    • San Diego, California, United States, 92121
      • Clinical Innovations, Inc.
    • Sherman Oaks, California, United States, 91403
      • California Neuroscience Research Medical Group, Inc
    • Temecula, California, United States, 92591
      • Viking Clinical Research Center
    • Torrance, California, United States, 90502
      • Collaborative Neuroscience Network, Inc. South Bay
    • Upland, California, United States, 91786
      • Pacific Clinical Research Medical Group
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Clinical Neuroscience Solutions Incorporated
    • Kissimmee, Florida, United States, 34741
      • Accurate Clinical Trials, Inc.
    • Maitland, Florida, United States, 32751
      • Florida Clinical Research Center, LLC
    • St. Petersburg, Florida, United States, 33716
      • Comprehensive NeuroScience, Inc.
    • West Palm Beach, Florida, United States, 33407
      • Janus Center For Psychiatric Research
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Atlanta Center for Medical Research
    • Atlanta, Georgia, United States, 30328
      • Comprehensive Neuroscience, Incorporated
    • Smyrna, Georgia, United States, 30080
      • Carman Research
  • Illinois
    • Joliet, Illinois, United States, 60435
      • Joliet Center for Clinical Research
    • Libertyville, Illinois, United States, 60048
      • Capstone Clinical Research
    • Naperville, Illinois, United States, 60563
      • AMR-Baber Research Inc.
    • Oak Brook, Illinois, United States, 60523
      • American Medical Research, Inc.
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Psychiatric Associates
    • Wichita, Kansas, United States, 67214
      • Via Christi Research
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Pharmasite Research Inc
  • Missouri
    • St. Charles, Missouri, United States, 63301
      • Midwest Research Group
  • Nebraska
    • North Platte, Nebraska, United States, 69101
      • Heartland Pharma Development
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • CRI Worldwide, LLC
  • New York
    • Brooklyn, New York, United States, 11235
      • Social Psychiatry Research Institute
    • Cedarhurst, New York, United States, 11516
      • Neurobehavioral Research, Inc
    • New York, New York, United States, 10021
      • Eastside Comprehensive Medical Center, LLC
    • New York, New York, United States, 10023
      • Medical and Behavioral Health Research Pc
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Odyssey Research
    • Fargo, North Dakota, United States, 58103
      • Prairie St. Johns Clinic - Fargo
    • Fargo, North Dakota, United States, 58104
      • Plains Medical Clinic
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • NorthCoast Clinical Trials Inc.
    • Canton, Ohio, United States, 44718
      • Neuro-Behavioral Clinical Research, Inc.
    • Cincinnati, Ohio, United States, 45215
      • Patient Priority Clinical Sites, LLC
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73116
      • Cutting Edge Research Group
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Research Network (Oregon), Inc.
    • Portland, Oregon, United States, 97210
      • Oregon Center for Clinical Investigations, Inc.
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Lehigh Center for Clinical Research
    • Media, Pennsylvania, United States, 19063
      • Suburban Research Associates
    • Philadelphia, Pennsylvania, United States, 19139
      • CRI Worldwide, LLC
  • Rhode Island
    • Lincoln, Rhode Island, United States, 02865
      • Lincoln Research
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Carolina Clinical Research Services
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Trials
    • Dallas, Texas, United States, 75230
      • KRK Medical Research
    • Dallas, Texas, United States, 75231
      • FutureSearch Trials of Dallas
    • Houston, Texas, United States, 77090
      • Red Oak Psychiatry Associates, PA
  • Utah
    • Murray, Utah, United States, 84123
      • Radiant Research, Inc.
  • Washington
    • Kirkland, Washington, United States, 98033
      • Eastside Therapeutic Resource
    • Seattle, Washington, United States, 98104
      • Summit Research Network (Seattle) Llc

Participation Criteria

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:

• Male or female outpatients aged 18 years or older who are fluent in written and spoken English.
• A primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode, without psychotic features.
• A HAM-D17 total score ≥20 at the screening and baseline (study day -1) visits and no more than a 4-point improvement from screening to baseline.

Exclusion Criteria:

• Significant risk of suicide based on clinical judgment.
• 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.
• Current generalized anxiety disorder, panic disorder, or social anxiety disorder.
• History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs.
• Any unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: placebo; 50 mg and 100 mg placebo matching tablets taken orally once daily for 8 weeks; 1 week of placebo taper
EXPERIMENTAL: desvenlafaxine succinate sustained-release 50 mg/day	Drug: desvenlafaxine succinate sustained-release 50 mg/day; 50 mg tablets of DVS SR taken orally once daily for 8 weeks; 1 week of placebo taper; Other Names: Pristiq
EXPERIMENTAL: desvenlafaxine succinate sustained-release 100 mg/day	Drug: desvenlafaxine succinate sustained-release 100 mg/day; 100 mg tablets of DVS SR taken orally once daily for 8 weeks (which includes 1 week of titration at 50 mg/day); 1 week of taper at 50 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8	HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline.	Baseline to Week 8 (final on-therapy)
Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8	HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline	Baseline to Week 8 (final on-therapy)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)	CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = worse outcome.	Baseline to Week 8 (final on-therapy)
Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)	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 = worse state.	Baseline to Week 8 (final on-therapy)
Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score	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 = worse state.	Baseline to Week 8 (final on-therapy)
Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate	HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score.	Baseline to Week 8 (final on-therapy)
Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate	HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score of ≤ 7.	Baseline to week 8 (final on-therapy)
Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score	The ASEX scale has 5 items to assess sexual functioning with a 1-week recall period. The 5 items assess sex drive, ease of arousal, ease of erection/lubrication, ease of orgasm and orgasm satisfaction. Subjects were encouraged to complete all 5 items regardless of sexual activity during the past week. However, all analyses utilized only the data for the visits where the presence of sexual activity was indicated. Each individual score ranged from 1 to 6; the total score (based on the sum of the individual items) ranged from 5 to 30; higher scores indicated worse sexual function.	Baseline to Week 8 (final on-therapy)

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.
• 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.
• 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.
• Clayton AH, Tourian KA, Focht K, Hwang E, Cheng RF, Thase ME. Desvenlafaxine 50 and 100 mg/d versus placebo for the treatment of major depressive disorder: a phase 4, randomized controlled trial. J Clin Psychiatry. 2015 May;76(5):562-9. doi: 10.4088/JCP.13m08978.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): July 1, 2012
• Study Completion (ACTUAL): August 1, 2012

Study Registration Dates

• First Submitted: September 9, 2011
• First Submitted That Met QC Criteria: September 9, 2011
• First Posted (ESTIMATE): September 13, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 20, 2014
• Last Update Submitted That Met QC Criteria: December 17, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; 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: B2061028; 3151A1-4420