Long-Term Safety Of DVS-233 SR In Patients With Major Depressive Disorder
A 10 Month Open-Label Evaluation Of The Long-Term Safety Of DVS-233 SR In Outpatients With Major Depressive Disorder.
2 other identifiers
interventional
1,403
11 countries
117
Brief Summary
The study evaluated the long-term safety of Desvenlafaxine Succinate (DVS) Slow Release (SR) during open-label treatment in adult outpatients who had a primary diagnosis of major depressive disorder (MDD). The study also evaluated the long-term response of subjects receiving DVS SR for clinical global evaluation, functionality, general well-being, pain, and absence of depressive symptoms (remission).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 major-depressive-disorder
Started Aug 2003
Typical duration for phase_3 major-depressive-disorder
117 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
Study Start
First participant enrolled
August 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 24, 2011
CompletedFirst Posted
Study publicly available on registry
March 7, 2011
CompletedApril 26, 2011
April 1, 2011
2.6 years
February 24, 2011
April 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number (%) of Subjects Reporting Adverse Events during Treatment
10 months
Number (%) of Subjects With Changes in Vital Signs (Blood Pressure, Pulse Rate, Weight) of Potential Clinical Importance
10 months
Number (%) of Subjects With Laboratory Test Results (Hematology, Blood Chemistry, Lipid Profile, Urinalysis) of Potential Clinical Importance
10 months
Number (%) of Subjects With Electrocardiogram Results (Heart Rate, QTc interval) of Potential Clinical Importance
10 months
Secondary Outcomes (3)
Change in Hamilton Depression Rating scale - 17 items version - (HAM-D17) mean score from baseline
10 months
Change in Montgomery Asberg Depression Rating Scale (MADRS)mean score from baseline
10 months
Change in Clinical Global Improvement Scale-Severity (CGI-S)mean score from baseline
10 months
Study Arms (1)
DVS
EXPERIMENTALInterventions
Tablet were taken at a daily dose of 200 to 400 mg/day for a duration up to 10 months
Eligibility Criteria
You may qualify if:
- Outpatients who have completed double-blind therapy in a phase 3 DVS-233 SR short-term study for the indication of MDD, including scheduled evaluations, with no major protocol violations and no study events that, in the opinion of the investigator, would preclude the subject's entry into the long-term, open-label study.
- Sexually active individuals participating in the study must use a medically acceptable form of contraception during the trial and for at least 15 days after the last dose of study drug.
You may not qualify if:
- Clinically important abnormalities on baseline physical examination, or any unresolved clinically significant abnormalities on ECG, laboratory test results, or vital signs recorded in a previous phase 3 DVS-233 SR short-term study for the indication of MDD. Any exception must be discussed with and granted by the sponsor.
- Significant risk of suicide based on clinical judgment, including common suicidal thoughts, and suicide being considered as a possible solution, even without specific plans or intention.
- Presence of clinically important hepatic or renal disease or other medical disease that might compromise the study or be detrimental to the subject (eg, clinically important cardiac arrhythmia, uncontrolled diabetes, uncontrolled hypertension, seizure disorder, myocardial infarction, neurologic disorder, acute illness, neoplastic disorder).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (117)
Birmingham Research Group Inc.
Birmingham, Alabama, 35216, United States
Pivotal Research Centers 13128 North 94th Drive, Suite 200
Mesa, Arizona, 85210, United States
Pivotal Research
Peoria, Arizona, 85381, United States
Southwestern Research, Inc.
Beverly Hills, California, 90210, United States
Feighner Research Institute
Chula Vista, California, 91910, United States
California Clinical Trials Medical Group, Inc.
Glendale, California, 91206, United States
Pharmacology Research Institute
Newport Beach, California, 92660, United States
Pacific Clinical Research
Orange, California, 92868, United States
UCSD Department of Psychiatry Psychopharmacology Research
San Diego, California, 92103, United States
Southwestern Research, Inc.
Tustin, California, 92780, United States
Alpine Clinical Research Center, Inc.
Boulder, Colorado, 80304, United States
Feiger Health Research Center
Lakewood, Colorado, 80401, United States
University of Connecticut Health Center
Farmington, Connecticut, 06030-6415, United States
New Britain General Hospital
New Britain, Connecticut, 06050, United States
The George Washington University Medical Center
Washington D.C., District of Columbia, 20037, United States
CORE Research, Inc.1006 NW 14
Leesburg, Florida, 34748, United States
Lifestream Behavioral Center
Leesburg, Florida, 34748, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32819, United States
Miami Research Associates, Inc.
South Miami, Florida, 33143, United States
Comprehensive NeuroScience, Inc.
St. Petersburg, Florida, 33702, United States
Kolin Research Group 1065 West Morse Blvd. Suite 202
Winter Park, Florida, 32789, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30308, United States
Atlanta Institute of Medicine & Research
Marietta, Georgia, 30060, United States
Carman Research
Smyrna, Georgia, 30080, United States
Radiant Research - Chicago
Chicago, Illinois, 60610, United States
Ingenium Clinical Research
Libertyville, Illinois, 60048, United States
Capital Clinical Research Associates, LLP
Rockville, Maryland, 20852, United States
DuPont Clinical Research, Inc.
Rockville, Maryland, 20852, United States
Institute for Health Studies
Okemos, Michigan, 48864, United States
Creighton University
Omaha, Nebraska, 68131, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002, United States
CRI Worldwide, LLC
Clementon, New Jersey, 08021, United States
Social Psychiatry Research Institute
New York, New York, 10021, United States
The Medical Research Network
New York, New York, 10024, United States
Anxiety & Depression Clinic
The Bronx, New York, 10467, United States
Piedmont Neuropsychiatry
Charlotte, North Carolina, 28226, United States
Hartford Research Group
Cincinnati, Ohio, 45242, United States
Midwest Clinical Research Center, LLC
Dayton, Ohio, 45408, United States
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, 43623, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Summit Research Network (Oregon), Inc.
Portland, Oregon, 97210, United States
Southeastern Pennsylvania Medical Institute
Havertown, Pennsylvania, 19083, United States
RI Mood & Memory Research Institute
East Providence, Rhode Island, 02914, United States
Southeast Health Consultants, LLC
Charleston, South Carolina, 29407, United States
Carolina Clinical Research Services
Columbia, South Carolina, 29201, United States
FutureSearch Trials
Austin, Texas, 78756, United States
University of Texas Southwestern
Dallas, Texas, 75235, United States
Research Testing, Inc.
Houston, Texas, 77004, United States
Radiant Research Salt Lake City
Salt Lake City, Utah, 84107, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Summit Research Network (Seattle) LLC
Seattle, Washington, 98104, United States
Center for Anxiety and Depression
Seattle, Washington, 98105, United States
Northbrooke Research Center
Brown Deer, Wisconsin, 53223, United States
West Tallinn Central Hospital
Tallinn, Estonia, 126 18, Estonia
Jaanson-Lääne Outpatient Clinic
Tartu, Estonia, 50407, Estonia
Viljandi Hospital Foundation Psychiatric Clinic
Viljandi, Estonia, 71024, Estonia
Psychiatric Research Clinic of Kupio
Kuopio, Finland, 70110, Finland
Psykoforum OY
Tampere, Finland, SF-33200, Finland
Psykiatripalvelu AT Oy
Espoo, 02600, Finland
FF Research
Helsinki, 00180, Finland
Mehilainen clinic
Helsinki, 00260, Finland
Mehiläinen, HUCH
Helsinki, 00260, Finland
Hakaniemen Lääkäriasema
Helsinki, 00530, Finland
Satakunnanpsykiatripalvelu
Rauma, 26100, Finland
MediRoi Oy
Rovaniemi, 96100, Finland
Psychiatric Research clinic of Salo
Salo, 24100, Finland
Länsi-Suomen Erikoislaakaripalvelu Oy
Turku, SF-20100, Finland
Turku Psychiatric Services Aurakatu 14 B 3 Krs
Turku, SF-20100, Finland
57 rue Gamard
Joué-Les-Tours, France, 37300, France
1, avenue du 6 Juin
Caen, 14000, France
88 Rue Emmanuel Liais
Cherbourg, 50100, France
Centre Médico-Psychologique
Dole, 39100, France
Résidence St Michel
Douai, 59500, France
Immeuble Impérial
La Valette-du-Var, 83160, France
16 avenue Robert Schuman
Mulhouse, 68100, France
3 rue Marceau
Nantes, 44000, France
Office of Dr Marce Zins-Ritter
Orvault, 44700, France
22 rue de Nemours
Rennes, 35000, France
7, rue Georges Politzer
Saint-Cyr-l'École, 78210, France
13 place Gaston Paillhou
Tours, 37000, France
emovis GmbH
Berlin, 10629, Germany
Praxis fuer Psychiatrie, Dr. Franz
Berlin, 13053, Germany
Praxis für Psychiatrie, Dr. Alexander Schulze
Berlin, D-13156, Germany
Psychiatrische Praxis Dr. Hans-Peter Wunderlich
Dresden, 01097, Germany
Praxis f. Neurologie u. Psychiatrie Dr. Lutz D. Lohse
Dresden, 01139, Germany
Dr. D. Backhaus, Hildesheim
Hildesheim, 31134, Germany
Psychoneurological hospital of Jelgava, Dept No12
Jelgava, Latvia, 3008, Latvia
Riga Mental Health Care Center, Dept of Psychiatry
Riga, Latvia, 1005, Latvia
Strenci Psychiatric Hospital
Strenči, Latvia, 4730, Latvia
Medical center Neuromeda
Kaunas, Lithuania, 3000, Lithuania
Klaipeda Psychiatry Hospital
Klaipėda, Lithuania, 91251, Lithuania
Vilnius Mental Health Care
Vilnius, Lithuania, 10309, Lithuania
SP ZOZ Swietokrzyskie Centrum Psychiatrii w Morawicy
Gmina Morawica, Poland, 26-026, Poland
Poradnia Zdrowia Psychicznego w Chelmnie
Chełmno, 86-200, Poland
Akademii Medycznej w Bialymstoku
Choroszcz, 16-070, Poland
Wojewodzki Szpital Psychiatryczny
Gdansk, 80-282, Poland
Poradnia Zdrowia Psychicznego
Kutno, 99-300, Poland
Specjalistyczny Psychiatryczny ZOZ w Lodzi
Lodz, 91-229, Poland
Wojewodzki Szpital dla Nerwowo i Psychicznie Chorych
Lubiąż, 56-110, Poland
Wojewodzki Osrodek Lecznictwa Psychiatrycznego w Toruniu
Torun, 87-100, Poland
Wojewodzki Osrodek Lecznictwa Psychiatrycznego
Torun, 87-100, Poland
Inventiva Biomedical and Sport Research Sp. z o.o.
Tuszyn, 95-080, Poland
NZOZ Centrum Zdrowia Psychicznego
Wroclaw, 50-541, Poland
Klinicko-bolnicki centar Dr Dragisa Misovic - Dedinje
Belgrade, Serbia and Montenegro
Institut za mentalno zdravlje
Beograd, 11000, Serbia and Montenegro
University Hospital Bratislava
Bratislava, 82606, Slovakia
Nemocnica s poliklinikou Liptovsky Mikulas
Liptovský Mikuláš, 031 23, Slovakia
General Hospital in Trencín
Trenčín, 911 71, Slovakia
Westville Hospital
Westville, Durban, 4058, South Africa
Vista Clinic
Pretoria, Gauteng, 0046, South Africa
Westdene Research Centre
Bloemfontein, Republic of South Africa, 9301, South Africa
Vista Clinic
Pretoria, Republic of South Africa, 0046, South Africa
Dey Clinic
Pretoria, Republic of South Africa, South Africa
Paarl Medical Centre
Paarl, Western Cape, 7646, South Africa
Knighton Surgery
Cape Town, 7700, South Africa
2B Tre Mondi Office Park
Somerset West, South Africa
Welkom Mediclinic
Welkom, 9459, South Africa
Related Publications (1)
Tourian KA, Pitrosky B, Padmanabhan SK, Rosas GR. A 10-month, open-label evaluation of desvenlafaxine in outpatients with major depressive disorder. Prim Care Companion CNS Disord. 2011;13(2):PCC.10m00977. doi: 10.4088/PCC.10m00977blu.
PMID: 21977353DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 24, 2011
First Posted
March 7, 2011
Study Start
August 1, 2003
Primary Completion
March 1, 2006
Study Completion
March 1, 2006
Last Updated
April 26, 2011
Record last verified: 2011-04