Long-Term Safety Of DVS-233 SR In Patients With Major Depressive Disorder
- Registration Number
- NCT01309542
- Lead Sponsor
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1403
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DVS Desvenlafaxine Succinate -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (115)
Neurology & Neuroscience Center of Ohio
🇺🇸Toledo, Ohio, United States
Turku Psychiatric Services Aurakatu 14 B 3 Krs
🇫🇮Turku, Finland
The Medical Research Network
🇺🇸New York, New York, United States
Welkom Mediclinic
🇿🇦Welkom, South Africa
Vista Clinic
🇿🇦Pretoria, Republic of South Africa, South Africa
Riga Mental Health Care Center, Dept of Psychiatry
🇱🇻Riga, Latvia
Westville Hospital
🇿🇦Westville, Durban, South Africa
Knighton Surgery
🇿🇦Cape Town, South Africa
University Hospital Bratislava
🇸🇰Bratislava, Slovakia
Feighner Research Institute
🇺🇸Chula Vista, California, United States
California Clinical Trials Medical Group, Inc.
🇺🇸Glendale, California, United States
Pacific Clinical Research
🇺🇸Orange, California, United States
Carman Research
🇺🇸Smyrna, Georgia, United States
Ingenium Clinical Research
🇺🇸Libertyville, Illinois, United States
Midwest Clinical Research Center, LLC
🇺🇸Dayton, Ohio, United States
Hartford Research Group
🇺🇸Cincinatti, Ohio, United States
Social Psychiatry Research Institute
🇺🇸New York, New York, United States
FutureSearch Trials
🇺🇸Austin, Texas, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Southeastern Pennsylvania Medical Institute
🇺🇸Havertown, Pennsylvania, United States
RI Mood & Memory Research Institute
🇺🇸East Providence, Rhode Island, United States
Alpine Clinical Research Center, Inc.
🇺🇸Boulder, Colorado, United States
Feiger Health Research Center
🇺🇸Lakewood, Colorado, United States
Medical center Neuromeda
🇱🇹Kaunas, Lithuania
Akademii Medycznej w Bialymstoku
🇵🇱Choroszcz, Poland
Wojewodzki Szpital dla Nerwowo i Psychicznie Chorych
🇵🇱Lubiaz, Poland
NZOZ Centrum Zdrowia Psychicznego
🇵🇱Wroclaw, Poland
Birmingham Research Group Inc.
🇺🇸Birmingham, Alabama, United States
Pivotal Research Centers 13128 North 94th Drive, Suite 200
🇺🇸Mesa, Arizona, United States
UCSD Department of Psychiatry Psychopharmacology Research
🇺🇸San Diego, California, United States
Southwestern Research, Inc.
🇺🇸Tustin, California, United States
Atlanta Institute of Medicine & Research
🇺🇸Marietta, Georgia, United States
Radiant Research - Chicago
🇺🇸Chicago, Illinois, United States
Pharmacology Research Institute
🇺🇸Newport Beach, California, United States
New Britain General Hospital
🇺🇸New Britain, Connecticut, United States
Kolin Research Group 1065 West Morse Blvd. Suite 202
🇺🇸Winter Park, Florida, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Research Testing, Inc.
🇺🇸Houston, Texas, United States
Carolina Clinical Research Services
🇺🇸Columbia, South Carolina, United States
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
Radiant Research Salt Lake City
🇺🇸Salt Lake City, Utah, United States
Summit Research Network (Seattle) LLC
🇺🇸Seattle, Washington, United States
Center for Anxiety and Depression
🇺🇸Seattle, Washington, United States
Dey Clinic
🇿🇦Pretoria, Republic of South Africa, South Africa
2B Tre Mondi Office Park
🇿🇦Somerset West, South Africa
Lifestream Behavioral Center
🇺🇸Leesburg, Florida, United States
The George Washington University Medical Center
🇺🇸Washington, District of Columbia, United States
Anxiety & Depression Clinic
🇺🇸Bronx, New York, United States
Piedmont Neuropsychiatry
🇺🇸Charlotte, North Carolina, United States
CRI Worldwide, LLC
🇺🇸Clementon, New Jersey, United States
Klinicko-bolnicki centar Dr Dragisa Misovic - Dedinje
Belgrade, Former Serbia and Montenegro
Institut za mentalno zdravlje
Beograd, Former Serbia and Montenegro
57 rue Gamard
🇫🇷Joué-Les-Tours, France
SP ZOZ Swietokrzyskie Centrum Psychiatrii w Morawicy
🇵🇱Morawica, Poland
Poradnia Zdrowia Psychicznego w Chelmnie
🇵🇱Chelmno, Poland
Inventiva Biomedical and Sport Research Sp. z o.o.
🇵🇱Tuszyn, Poland
Westdene Research Centre
🇿🇦Bloemfontein, Republic of South Africa, South Africa
Strenci Psychiatric Hospital
🇱🇻Strenci, Latvia
1, avenue du 6 Juin
🇫🇷Caen, France
22 rue de Nemours
🇫🇷Rennes, France
13 place Gaston Paillhou
🇫🇷Tours, France
Vilnius Mental Health Care
🇱🇹Vilnius, Lithuania
Clinical Neuroscience Solutions, Inc.
🇺🇸Orlando, Florida, United States
CORE Research, Inc.1006 NW 14
🇺🇸Leesburg, Florida, United States
Institute for Health Studies
🇺🇸Okemos, Michigan, United States
Pivotal Research
🇺🇸Peoria, Arizona, United States
Creighton University
🇺🇸Omaha, Nebraska, United States
Psykoforum OY
🇫🇮Tampere, Finland
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Hakaniemen Lääkäriasema
🇫🇮Helsinki, Finland
Psychiatric Research clinic of Salo
🇫🇮Salo, Finland
Résidence St Michel
🇫🇷Douai, France
16 avenue Robert Schuman
🇫🇷Mulhouse, France
3 rue Marceau
🇫🇷Nantes, France
7, rue Georges Politzer
🇫🇷Saint Cyr l'Ecole, France
Praxis f. Neurologie u. Psychiatrie Dr. Lutz D. Lohse
🇩🇪Dresden, Germany
Dr. D. Backhaus, Hildesheim
🇩🇪Hildesheim, Germany
Southeast Health Consultants, LLC
🇺🇸Charleston, South Carolina, United States
West Tallinn Central Hospital
🇪🇪Tallinn, Estonia
MediRoi Oy
🇫🇮Rovaniemi, Finland
Länsi-Suomen Erikoislaakaripalvelu Oy
🇫🇮Turku, Finland
Psychiatrische Praxis Dr. Hans-Peter Wunderlich
🇩🇪Dresden, Germany
Poradnia Zdrowia Psychicznego
🇵🇱Kutno, Poland
Nemocnica s poliklinikou Liptovsky Mikulas
🇸🇰Liptovsky Mikulas, Slovakia
Comprehensive NeuroScience, Inc.
🇺🇸St. Petersburg, Florida, United States
Summit Research Network (Oregon), Inc.
🇺🇸Portland, Oregon, United States
emovis GmbH
🇩🇪Berlin, Germany
Praxis fuer Psychiatrie, Dr. Franz
🇩🇪Berlin, Germany
Psykiatripalvelu AT Oy
🇫🇮Espoo, Finland
Mehilainen clinic
🇫🇮Helsinki, Finland
Mehiläinen, HUCH
🇫🇮Helsinki, Finland
Psychiatric Research Clinic of Kupio
🇫🇮Kuopio, Finland
Satakunnanpsykiatripalvelu
🇫🇮Rauma, Finland
Centre Médico-Psychologique
🇫🇷Dole, France
Immeuble Impérial
🇫🇷La Valette du Var, France
Office of Dr Marce Zins-Ritter
🇫🇷Orvault, France
Wojewodzki Szpital Psychiatryczny
🇵🇱Gdansk, Poland
Wojewodzki Osrodek Lecznictwa Psychiatrycznego w Toruniu
🇵🇱Torun, Poland
Wojewodzki Osrodek Lecznictwa Psychiatrycznego
🇵🇱Torun, Poland
Miami Research Associates, Inc.
🇺🇸South Miami, Florida, United States
Jaanson-Lääne Outpatient Clinic
🇪🇪Tartu, Estonia
Viljandi Hospital Foundation Psychiatric Clinic
🇪🇪Viljandi, Estonia
FF Research
🇫🇮Helsinki, Finland
88 Rue Emmanuel Liais
🇫🇷Cherbourg, France
Psychoneurological hospital of Jelgava, Dept No12
🇱🇻Jelgava, Latvia
Klaipeda Psychiatry Hospital
🇱🇹Klaipeda, Lithuania
Specjalistyczny Psychiatryczny ZOZ w Lodzi
🇵🇱Lodz, Poland
General Hospital in TrencÃn
🇸🇰Trencin, Slovakia
Center for Emotional Fitness
🇺🇸Cherry Hill, New Jersey, United States
Northbrooke Research Center
🇺🇸Brown Deer, Wisconsin, United States
Paarl Medical Centre
🇿🇦Paarl, Western Cape, South Africa
Capital Clinical Research Associates, LLP
🇺🇸Rockville, Maryland, United States
DuPont Clinical Research, Inc.
🇺🇸Rockville, Maryland, United States
Praxis für Psychiatrie, Dr. Alexander Schulze
🇩🇪Berlin, Germany