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
2 other identifiers
interventional
924
1 country
61
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 major-depressive-disorder
Started Oct 2011
Shorter than P25 for phase_4 major-depressive-disorder
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2011
CompletedFirst Posted
Study publicly available on registry
September 13, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
January 20, 2014
CompletedJanuary 20, 2014
December 1, 2013
9 months
September 9, 2011
June 27, 2013
December 17, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)
Baseline to Week 8 (final on-therapy)
Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)
Baseline to Week 8 (final on-therapy)
Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score
Baseline to Week 8 (final on-therapy)
Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate
Baseline to Week 8 (final on-therapy)
Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate
Baseline to week 8 (final on-therapy)
- +1 more secondary outcomes
Study Arms (3)
desvenlafaxine succinate sustained-release 50 mg/day
EXPERIMENTALdesvenlafaxine succinate sustained-release 100 mg/day
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
50 mg tablets of DVS SR taken orally once daily for 8 weeks; 1 week of placebo taper
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
50 mg and 100 mg placebo matching tablets taken orally once daily for 8 weeks; 1 week of placebo taper
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (61)
Dedicated Clinical Research
Phoenix, Arizona, 85020, United States
Deidcated Clinical Research
Phoenix, Arizona, 85020, United States
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
Little Rock, Arkansas, 72223, United States
Pacific Clinical Research Medical Group
Arcadia, California, 91007, United States
Southwestern Research, Incorporated
Beverly Hills, California, 90210, United States
Clinical Innovations, Inc.
Costa Mesa, California, 92626, United States
Synergy Clinical Research of Escondido
Escondido, California, 92027, United States
Synergy Clinical Research Center
National City, California, 91950, United States
Pacific Research Partners
Oakland, California, 94612, United States
Pasadena Research Institute, LLC
Pasadena, California, 91106, United States
Clinical Innovations, Inc.
Riverside, California, 92506, United States
Affiliated Research Institute
San Diego, California, 92108, United States
Clinical Innovations, Inc.
San Diego, California, 92121, United States
California Neuroscience Research Medical Group, Inc
Sherman Oaks, California, 91403, United States
Viking Clinical Research Center
Temecula, California, 92591, United States
Collaborative Neuroscience Network, Inc. South Bay
Torrance, California, 90502, United States
Pacific Clinical Research Medical Group
Upland, California, 91786, United States
Clinical Neuroscience Solutions Incorporated
Jacksonville, Florida, 32216, United States
Accurate Clinical Trials, Inc.
Kissimmee, Florida, 34741, United States
Florida Clinical Research Center, LLC
Maitland, Florida, 32751, United States
Comprehensive NeuroScience, Inc.
St. Petersburg, Florida, 33716, United States
Janus Center for Psychiatric Research
West Palm Beach, Florida, 33407, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30308, United States
Comprehensive NeuroScience, Incorporated
Atlanta, Georgia, 30328, United States
Carman Research
Smyrna, Georgia, 30080, United States
Joliet Center for Clinical Research
Joliet, Illinois, 60435, United States
Capstone Clinical Research
Libertyville, Illinois, 60048, United States
AMR-Baber Research Inc.
Naperville, Illinois, 60563, United States
American Medical Research, Inc.
Oak Brook, Illinois, 60523, United States
Psychiatric Associates
Overland Park, Kansas, 66211, United States
Via Christi Research
Wichita, Kansas, 67214, United States
Pharmasite Research Inc
Baltimore, Maryland, 21208, United States
Midwest Research Group
Saint Charles, Missouri, 63301, United States
Heartland Pharma Development
North Platte, Nebraska, 69101, United States
CRI Worldwide, LLC
Marlton, New Jersey, 08053, United States
Social Psychiatry Research Institute
Brooklyn, New York, 11235, United States
Neurobehavioral Research, Inc
Cedarhurst, New York, 11516, United States
Eastside Comprehensive Medical Center, LLC
New York, New York, 10021, United States
Medical and Behavioral Health Research Pc
New York, New York, 10023, United States
Prairie St. Johns Clinic - Fargo
Fargo, North Dakota, 58103, United States
Odyssey Research
Fargo, North Dakota, 58104, United States
Plains Medical Clinic
Fargo, North Dakota, 58104, United States
NorthCoast Clinical Trials Inc.
Beachwood, Ohio, 44122, United States
Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio, 44718, United States
Patient Priority Clinical Sites, LLC
Cincinnati, Ohio, 45215, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116, United States
Oregon Center for Clinical Investigations, Inc.
Portland, Oregon, 97210, United States
Summit Research Network (Oregon), Inc.
Portland, Oregon, 97210, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
CRI Worldwide, LLC
Philadelphia, Pennsylvania, 19139, United States
Lincoln Research
Lincoln, Rhode Island, 02865, United States
Carolina Clinical Research Services
Columbia, South Carolina, 29201, United States
FutureSearch Trials
Austin, Texas, 78731, United States
KRK Medical Research
Dallas, Texas, 75230, United States
FutureSearch Trials of Dallas
Dallas, Texas, 75231, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090, United States
Radiant Research, Inc.
Murray, Utah, 84123, United States
Eastside Therapeutic Resource
Kirkland, Washington, 98033, United States
Summit Research Network (Seattle) LLC
Seattle, Washington, 98104, United States
Related Publications (4)
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.
PMID: 34183490DERIVEDMcIntyre 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.
PMID: 26709542DERIVEDThase 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.
PMID: 25758058DERIVEDClayton 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.
PMID: 25375652DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2011
First Posted
September 13, 2011
Study Start
October 1, 2011
Primary Completion
July 1, 2012
Study Completion
August 1, 2012
Last Updated
January 20, 2014
Results First Posted
January 20, 2014
Record last verified: 2013-12