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Trial record 85 of 6154 for:    "Depressive Disorder" [DISEASE]

Long-Term Safety Of DVS-233 SR In Patients With Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01309542
Recruitment Status : Completed
First Posted : March 7, 2011
Last Update Posted : April 26, 2011
Sponsor:
Information provided by:
Pfizer

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).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Desvenlafaxine Succinate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1403 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 10 Month Open-Label Evaluation Of The Long-Term Safety Of DVS-233 SR In Outpatients With Major Depressive Disorder.
Study Start Date : August 2003
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DVS Drug: Desvenlafaxine Succinate
Tablet were taken at a daily dose of 200 to 400 mg/day for a duration up to 10 months
Other Name: DVS-233 SR




Primary Outcome Measures :
  1. Number (%) of Subjects Reporting Adverse Events during Treatment [ Time Frame: 10 months ]
  2. Number (%) of Subjects With Changes in Vital Signs (Blood Pressure, Pulse Rate, Weight) of Potential Clinical Importance [ Time Frame: 10 months ]
  3. Number (%) of Subjects With Laboratory Test Results (Hematology, Blood Chemistry, Lipid Profile, Urinalysis) of Potential Clinical Importance [ Time Frame: 10 months ]
  4. Number (%) of Subjects With Electrocardiogram Results (Heart Rate, QTc interval) of Potential Clinical Importance [ Time Frame: 10 months ]

Secondary Outcome Measures :
  1. Change in Hamilton Depression Rating scale - 17 items version - (HAM-D17) mean score from baseline [ Time Frame: 10 months ]
  2. Change in Montgomery Asberg Depression Rating Scale (MADRS)mean score from baseline [ Time Frame: 10 months ]
  3. Change in Clinical Global Improvement Scale-Severity (CGI-S)mean score from baseline [ Time Frame: 10 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01309542


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Locations
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United States, Alabama
Birmingham Research Group Inc.
Birmingham, Alabama, United States, 35216
United States, Arizona
Pivotal Research Centers 13128 North 94th Drive, Suite 200
Mesa, Arizona, United States, 85210
Pivotal Research
Peoria, Arizona, United States, 85381
United States, California
Southwestern Research, Inc.
Beverly Hills, California, United States, 90210
Feighner Research Institute
Chula Vista, California, United States, 91910
California Clinical Trials Medical Group, Inc.
Glendale, California, United States, 91206
Pharmacology Research Institute
Newport Beach, California, United States, 92660
Pacific Clinical Research
Orange, California, United States, 92868
UCSD Department of Psychiatry Psychopharmacology Research
San Diego, California, United States, 92103
Southwestern Research, Inc.
Tustin, California, United States, 92780
United States, Colorado
Alpine Clinical Research Center, Inc.
Boulder, Colorado, United States, 80304
Feiger Health Research Center
Lakewood, Colorado, United States, 80401
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030-6415
New Britain General Hospital
New Britain, Connecticut, United States, 06050
United States, District of Columbia
The George Washington University Medical Center
Washington, District of Columbia, United States, 20037
United States, Florida
CORE Research, Inc.1006 NW 14
Leesburg, Florida, United States, 34748
Lifestream Behavioral Center
Leesburg, Florida, United States, 34748
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States, 32819
Miami Research Associates, Inc.
South Miami, Florida, United States, 33143
Comprehensive NeuroScience, Inc.
St. Petersburg, Florida, United States, 33702
Kolin Research Group 1065 West Morse Blvd. Suite 202
Winter Park, Florida, United States, 32789
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
Atlanta Institute of Medicine & Research
Marietta, Georgia, United States, 30060
Carman Research
Smyrna, Georgia, United States, 30080
United States, Illinois
Radiant Research - Chicago
Chicago, Illinois, United States, 60610
Ingenium Clinical Research
Libertyville, Illinois, United States, 60048
United States, Maryland
Capital Clinical Research Associates, LLP
Rockville, Maryland, United States, 20852
DuPont Clinical Research, Inc.
Rockville, Maryland, United States, 20852
United States, Michigan
Institute for Health Studies
Okemos, Michigan, United States, 48864
United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131
United States, New Jersey
Center for Emotional Fitness
Cherry Hill, New Jersey, United States, 08002
CRI Worldwide, LLC
Clementon, New Jersey, United States, 08021
United States, New York
Anxiety & Depression Clinic
Bronx, New York, United States, 10467
Social Psychiatry Research Institute
New York, New York, United States, 10021
The Medical Research Network
New York, New York, United States, 10024
United States, North Carolina
Piedmont Neuropsychiatry
Charlotte, North Carolina, United States, 28226
United States, Ohio
Hartford Research Group
Cincinatti, Ohio, United States, 45242
Midwest Clinical Research Center, LLC
Dayton, Ohio, United States, 45408
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, United States, 43623
United States, Oklahoma
IPS Research Company
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Summit Research Network (Oregon), Inc.
Portland, Oregon, United States, 97210
United States, Pennsylvania
Southeastern Pennsylvania Medical Institute
Havertown, Pennsylvania, United States, 19083
United States, Rhode Island
RI Mood & Memory Research Institute
East Providence, Rhode Island, United States, 02914
United States, South Carolina
Southeast Health Consultants, LLC
Charleston, South Carolina, United States, 29407
Carolina Clinical Research Services
Columbia, South Carolina, United States, 29201
United States, Texas
FutureSearch Trials
Austin, Texas, United States, 78756
University of Texas Southwestern
Dallas, Texas, United States, 75235
Research Testing, Inc.
Houston, Texas, United States, 77004
United States, Utah
Radiant Research Salt Lake City
Salt Lake City, Utah, United States, 84107
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Summit Research Network (Seattle) LLC
Seattle, Washington, United States, 98104
Center for Anxiety and Depression
Seattle, Washington, United States, 98105
United States, Wisconsin
Northbrooke Research Center
Brown Deer, Wisconsin, United States, 53223
Estonia
West Tallinn Central Hospital
Tallinn, Estonia, 126 18
Jaanson-Lääne Outpatient Clinic
Tartu, Estonia, 50407
Viljandi Hospital Foundation Psychiatric Clinic
Viljandi, Estonia, 71024
Finland
Psykiatripalvelu AT Oy
Espoo, Finland, 02600
FF Research
Helsinki, Finland, 00180
Mehilainen clinic
Helsinki, Finland, 00260
Mehiläinen, HUCH
Helsinki, Finland, 00260
Hakaniemen Lääkäriasema
Helsinki, Finland, 00530
Psychiatric Research Clinic of Kupio
Kuopio, Finland, 70110
Satakunnanpsykiatripalvelu
Rauma, Finland, 26100
MediRoi Oy
Rovaniemi, Finland, 96100
Psychiatric Research clinic of Salo
Salo, Finland, 24100
Psykoforum OY
Tampere, Finland, SF-33200
Länsi-Suomen Erikoislaakaripalvelu Oy
Turku, Finland, SF-20100
Turku Psychiatric Services Aurakatu 14 B 3 Krs
Turku, Finland, SF-20100
Former Serbia and Montenegro
Klinicko-bolnicki centar Dr Dragisa Misovic - Dedinje
Belgrade, Former Serbia and Montenegro
Institut za mentalno zdravlje
Beograd, Former Serbia and Montenegro, 11000
France
1, avenue du 6 Juin
Caen, France, 14000
88 Rue Emmanuel Liais
Cherbourg, France, 50100
Centre Médico-Psychologique
Dole, France, 39100
Résidence St Michel
Douai, France, 59500
57 rue Gamard
Joué-Les-Tours, France, 37300
Immeuble Impérial
La Valette du Var, France, 83160
16 avenue Robert Schuman
Mulhouse, France, 68100
3 rue Marceau
Nantes, France, 44000
Office of Dr Marce Zins-Ritter
Orvault, France, 44700
22 rue de Nemours
Rennes, France, 35000
7, rue Georges Politzer
Saint Cyr l'Ecole, France, 78210
13 place Gaston Paillhou
Tours, France, 37000
Germany
emovis GmbH
Berlin, Germany, 10629
Praxis fuer Psychiatrie, Dr. Franz
Berlin, Germany, 13053
Praxis für Psychiatrie, Dr. Alexander Schulze
Berlin, Germany, D-13156
Psychiatrische Praxis Dr. Hans-Peter Wunderlich
Dresden, Germany, 01097
Praxis f. Neurologie u. Psychiatrie Dr. Lutz D. Lohse
Dresden, Germany, 01139
Dr. D. Backhaus, Hildesheim
Hildesheim, Germany, 31134
Latvia
Psychoneurological hospital of Jelgava, Dept No12
Jelgava, Latvia, 3008
Riga Mental Health Care Center, Dept of Psychiatry
Riga, Latvia, 1005
Strenci Psychiatric Hospital
Strenci, Latvia, 4730
Lithuania
Medical center Neuromeda
Kaunas, Lithuania, 3000
Klaipeda Psychiatry Hospital
Klaipeda, Lithuania, 91251
Vilnius Mental Health Care
Vilnius, Lithuania, 10309
Poland
Poradnia Zdrowia Psychicznego w Chelmnie
Chelmno, Poland, 86-200
Akademii Medycznej w Bialymstoku
Choroszcz, Poland, 16-070
Wojewodzki Szpital Psychiatryczny
Gdansk, Poland, 80-282
Poradnia Zdrowia Psychicznego
Kutno, Poland, 99-300
Specjalistyczny Psychiatryczny ZOZ w Lodzi
Lodz, Poland, 91-229
Wojewodzki Szpital dla Nerwowo i Psychicznie Chorych
Lubiaz, Poland, 56-110
SP ZOZ Swietokrzyskie Centrum Psychiatrii w Morawicy
Morawica, Poland, 26-026
Wojewodzki Osrodek Lecznictwa Psychiatrycznego w Toruniu
Torun, Poland, 87-100
Wojewodzki Osrodek Lecznictwa Psychiatrycznego
Torun, Poland, 87-100
Inventiva Biomedical and Sport Research Sp. z o.o.
Tuszyn, Poland, 95-080
NZOZ Centrum Zdrowia Psychicznego
Wroclaw, Poland, 50-541
Slovakia
University Hospital Bratislava
Bratislava, Slovakia, 82606
Nemocnica s poliklinikou Liptovsky Mikulas
Liptovsky Mikulas, Slovakia, 031 23
General Hospital in Trencín
Trencin, Slovakia, 911 71
South Africa
Westville Hospital
Westville, Durban, South Africa, 4058
Vista Clinic
Pretoria, Gauteng, South Africa, 0046
Westdene Research Centre
Bloemfontein, Republic of South Africa, South Africa, 9301
Vista Clinic
Pretoria, Republic of South Africa, South Africa, 0046
Dey Clinic
Pretoria, Republic of South Africa, South Africa
Paarl Medical Centre
Paarl, Western Cape, South Africa, 7646
Knighton Surgery
Cape Town, South Africa, 7700
2B Tre Mondi Office Park
Somerset West, South Africa
Welkom Mediclinic
Welkom, South Africa, 9459
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01309542     History of Changes
Other Study ID Numbers: 3151A1-303
B2061069
First Posted: March 7, 2011    Key Record Dates
Last Update Posted: April 26, 2011
Last Verified: April 2011

Keywords provided by Pfizer:
major depressive disorder
desvenlafaxine
antidepressant

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Disease
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Desvenlafaxine Succinate
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs