Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD)
NCT ID: NCT01432457
Last Updated: 2014-01-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
924 participants
INTERVENTIONAL
2011-10-31
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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desvenlafaxine succinate sustained-release 50 mg/day
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
desvenlafaxine succinate sustained-release 100 mg/day
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
Placebo
placebo
50 mg and 100 mg placebo matching tablets taken orally once daily for 8 weeks; 1 week of placebo taper
Interventions
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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
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
placebo
50 mg and 100 mg placebo matching tablets taken orally once daily for 8 weeks; 1 week of placebo taper
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Dedicated Clinical Research
Phoenix, Arizona, United States
Deidcated Clinical Research
Phoenix, Arizona, United States
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
Little Rock, Arkansas, United States
Pacific Clinical Research Medical Group
Arcadia, California, United States
Southwestern Research, Incorporated
Beverly Hills, California, United States
Clinical Innovations, Inc.
Costa Mesa, California, United States
Synergy Clinical Research of Escondido
Escondido, California, United States
Synergy Clinical Research Center
National City, California, United States
Pacific Research Partners
Oakland, California, United States
Pasadena Research Institute, LLC
Pasadena, California, United States
Clinical Innovations, Inc.
Riverside, California, United States
Affiliated Research Institute
San Diego, California, United States
Clinical Innovations, Inc.
San Diego, California, United States
California Neuroscience Research Medical Group, Inc
Sherman Oaks, California, United States
Viking Clinical Research Center
Temecula, California, United States
Collaborative Neuroscience Network, Inc. South Bay
Torrance, California, United States
Pacific Clinical Research Medical Group
Upland, California, United States
Clinical Neuroscience Solutions Incorporated
Jacksonville, Florida, United States
Accurate Clinical Trials, Inc.
Kissimmee, Florida, United States
Florida Clinical Research Center, LLC
Maitland, Florida, United States
Comprehensive NeuroScience, Inc.
St. Petersburg, Florida, United States
Janus Center for Psychiatric Research
West Palm Beach, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Comprehensive NeuroScience, Incorporated
Atlanta, Georgia, United States
Carman Research
Smyrna, Georgia, United States
Joliet Center for Clinical Research
Joliet, Illinois, United States
Capstone Clinical Research
Libertyville, Illinois, United States
AMR-Baber Research Inc.
Naperville, Illinois, United States
American Medical Research, Inc.
Oak Brook, Illinois, United States
Psychiatric Associates
Overland Park, Kansas, United States
Via Christi Research
Wichita, Kansas, United States
Pharmasite Research Inc
Baltimore, Maryland, United States
Midwest Research Group
Saint Charles, Missouri, United States
Heartland Pharma Development
North Platte, Nebraska, United States
CRI Worldwide, LLC
Marlton, New Jersey, United States
Social Psychiatry Research Institute
Brooklyn, New York, United States
Neurobehavioral Research, Inc
Cedarhurst, New York, United States
Eastside Comprehensive Medical Center, LLC
New York, New York, United States
Medical and Behavioral Health Research Pc
New York, New York, United States
Prairie St. Johns Clinic - Fargo
Fargo, North Dakota, United States
Odyssey Research
Fargo, North Dakota, United States
Plains Medical Clinic
Fargo, North Dakota, United States
NorthCoast Clinical Trials Inc.
Beachwood, Ohio, United States
Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio, United States
Patient Priority Clinical Sites, LLC
Cincinnati, Ohio, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States
Oregon Center for Clinical Investigations, Inc.
Portland, Oregon, United States
Summit Research Network (Oregon), Inc.
Portland, Oregon, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States
Suburban Research Associates
Media, Pennsylvania, United States
CRI Worldwide, LLC
Philadelphia, Pennsylvania, United States
Lincoln Research
Lincoln, Rhode Island, United States
Carolina Clinical Research Services
Columbia, South Carolina, United States
FutureSearch Trials
Austin, Texas, United States
KRK Medical Research
Dallas, Texas, United States
FutureSearch Trials of Dallas
Dallas, Texas, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, United States
Radiant Research, Inc.
Murray, Utah, United States
Eastside Therapeutic Resource
Kirkland, Washington, United States
Summit Research Network (Seattle) LLC
Seattle, Washington, United States
Countries
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References
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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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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3151A1-4420
Identifier Type: -
Identifier Source: secondary_id
B2061028
Identifier Type: -
Identifier Source: org_study_id
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