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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01309542
Collaborator
(none)
1,403
Enrollment
117
Locations
1
Arm
31
Duration (Months)
12
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Desvenlafaxine Succinate
 Phase 3

Study Design

Study Type:
Interventional
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 :
Aug 1, 2003
Actual Primary Completion Date :
Mar 1, 2006
Actual Study Completion Date :
Mar 1, 2006

Arms and Interventions

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 Names:
  • DVS-233 SR

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number (%) of Subjects Reporting Adverse Events during Treatment [10 months]

    2. Number (%) of Subjects With Changes in Vital Signs (Blood Pressure, Pulse Rate, Weight) of Potential Clinical Importance [10 months]

    3. Number (%) of Subjects With Laboratory Test Results (Hematology, Blood Chemistry, Lipid Profile, Urinalysis) of Potential Clinical Importance [10 months]

    4. Number (%) of Subjects With Electrocardiogram Results (Heart Rate, QTc interval) of Potential Clinical Importance [10 months]

    Secondary Outcome Measures

    1. Change in Hamilton Depression Rating scale - 17 items version - (HAM-D17) mean score from baseline [10 months]

    2. Change in Montgomery Asberg Depression Rating Scale (MADRS)mean score from baseline [10 months]

    3. Change in Clinical Global Improvement Scale-Severity (CGI-S)mean score from baseline [10 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Research Group Inc. Birmingham Alabama United States 35216
    2 Pivotal Research Centers 13128 North 94th Drive, Suite 200 Mesa Arizona United States 85210
    3 Pivotal Research Peoria Arizona United States 85381
    4 Southwestern Research, Inc. Beverly Hills California United States 90210
    5 Feighner Research Institute Chula Vista California United States 91910
    6 California Clinical Trials Medical Group, Inc. Glendale California United States 91206
    7 Pharmacology Research Institute Newport Beach California United States 92660
    8 Pacific Clinical Research Orange California United States 92868
    9 UCSD Department of Psychiatry Psychopharmacology Research San Diego California United States 92103
    10 Southwestern Research, Inc. Tustin California United States 92780
    11 Alpine Clinical Research Center, Inc. Boulder Colorado United States 80304
    12 Feiger Health Research Center Lakewood Colorado United States 80401
    13 University of Connecticut Health Center Farmington Connecticut United States 06030-6415
    14 New Britain General Hospital New Britain Connecticut United States 06050
    15 The George Washington University Medical Center Washington District of Columbia United States 20037
    16 CORE Research, Inc.1006 NW 14 Leesburg Florida United States 34748
    17 Lifestream Behavioral Center Leesburg Florida United States 34748
    18 Clinical Neuroscience Solutions, Inc. Orlando Florida United States 32819
    19 Miami Research Associates, Inc. South Miami Florida United States 33143
    20 Comprehensive NeuroScience, Inc. St. Petersburg Florida United States 33702
    21 Kolin Research Group 1065 West Morse Blvd. Suite 202 Winter Park Florida United States 32789
    22 Atlanta Center for Medical Research Atlanta Georgia United States 30308
    23 Atlanta Institute of Medicine & Research Marietta Georgia United States 30060
    24 Carman Research Smyrna Georgia United States 30080
    25 Radiant Research - Chicago Chicago Illinois United States 60610
    26 Ingenium Clinical Research Libertyville Illinois United States 60048
    27 Capital Clinical Research Associates, LLP Rockville Maryland United States 20852
    28 DuPont Clinical Research, Inc. Rockville Maryland United States 20852
    29 Institute for Health Studies Okemos Michigan United States 48864
    30 Creighton University Omaha Nebraska United States 68131
    31 Center for Emotional Fitness Cherry Hill New Jersey United States 08002
    32 CRI Worldwide, LLC Clementon New Jersey United States 08021
    33 Anxiety & Depression Clinic Bronx New York United States 10467
    34 Social Psychiatry Research Institute New York New York United States 10021
    35 The Medical Research Network New York New York United States 10024
    36 Piedmont Neuropsychiatry Charlotte North Carolina United States 28226
    37 Hartford Research Group Cincinatti Ohio United States 45242
    38 Midwest Clinical Research Center, LLC Dayton Ohio United States 45408
    39 Neurology & Neuroscience Center of Ohio Toledo Ohio United States 43623
    40 IPS Research Company Oklahoma City Oklahoma United States 73103
    41 Summit Research Network (Oregon), Inc. Portland Oregon United States 97210
    42 Southeastern Pennsylvania Medical Institute Havertown Pennsylvania United States 19083
    43 RI Mood & Memory Research Institute East Providence Rhode Island United States 02914
    44 Southeast Health Consultants, LLC Charleston South Carolina United States 29407
    45 Carolina Clinical Research Services Columbia South Carolina United States 29201
    46 FutureSearch Trials Austin Texas United States 78756
    47 University of Texas Southwestern Dallas Texas United States 75235
    48 Research Testing, Inc. Houston Texas United States 77004
    49 Radiant Research Salt Lake City Salt Lake City Utah United States 84107
    50 Northwest Clinical Research Center Bellevue Washington United States 98007
    51 Summit Research Network (Seattle) LLC Seattle Washington United States 98104
    52 Center for Anxiety and Depression Seattle Washington United States 98105
    53 Northbrooke Research Center Brown Deer Wisconsin United States 53223
    54 West Tallinn Central Hospital Tallinn Estonia 126 18
    55 Jaanson-Lääne Outpatient Clinic Tartu Estonia 50407
    56 Viljandi Hospital Foundation Psychiatric Clinic Viljandi Estonia 71024
    57 Psykiatripalvelu AT Oy Espoo Finland 02600
    58 FF Research Helsinki Finland 00180
    59 Mehilainen clinic Helsinki Finland 00260
    60 Mehiläinen, HUCH Helsinki Finland 00260
    61 Hakaniemen Lääkäriasema Helsinki Finland 00530
    62 Psychiatric Research Clinic of Kupio Kuopio Finland 70110
    63 Satakunnanpsykiatripalvelu Rauma Finland 26100
    64 MediRoi Oy Rovaniemi Finland 96100
    65 Psychiatric Research clinic of Salo Salo Finland 24100
    66 Psykoforum OY Tampere Finland SF-33200
    67 Länsi-Suomen Erikoislaakaripalvelu Oy Turku Finland SF-20100
    68 Turku Psychiatric Services Aurakatu 14 B 3 Krs Turku Finland SF-20100
    69 Klinicko-bolnicki centar Dr Dragisa Misovic - Dedinje Belgrade Former Serbia and Montenegro
    70 Institut za mentalno zdravlje Beograd Former Serbia and Montenegro 11000
    71 1, avenue du 6 Juin Caen France 14000
    72 88 Rue Emmanuel Liais Cherbourg France 50100
    73 Centre Médico-Psychologique Dole France 39100
    74 Résidence St Michel Douai France 59500
    75 57 rue Gamard Joué-Les-Tours France 37300
    76 Immeuble Impérial La Valette du Var France 83160
    77 16 avenue Robert Schuman Mulhouse France 68100
    78 3 rue Marceau Nantes France 44000
    79 Office of Dr Marce Zins-Ritter Orvault France 44700
    80 22 rue de Nemours Rennes France 35000
    81 7, rue Georges Politzer Saint Cyr l'Ecole France 78210
    82 13 place Gaston Paillhou Tours France 37000
    83 emovis GmbH Berlin Germany 10629
    84 Praxis fuer Psychiatrie, Dr. Franz Berlin Germany 13053
    85 Praxis für Psychiatrie, Dr. Alexander Schulze Berlin Germany D-13156
    86 Psychiatrische Praxis Dr. Hans-Peter Wunderlich Dresden Germany 01097
    87 Praxis f. Neurologie u. Psychiatrie Dr. Lutz D. Lohse Dresden Germany 01139
    88 Dr. D. Backhaus, Hildesheim Hildesheim Germany 31134
    89 Psychoneurological hospital of Jelgava, Dept No12 Jelgava Latvia 3008
    90 Riga Mental Health Care Center, Dept of Psychiatry Riga Latvia 1005
    91 Strenci Psychiatric Hospital Strenci Latvia 4730
    92 Medical center Neuromeda Kaunas Lithuania 3000
    93 Klaipeda Psychiatry Hospital Klaipeda Lithuania 91251
    94 Vilnius Mental Health Care Vilnius Lithuania 10309
    95 Poradnia Zdrowia Psychicznego w Chelmnie Chelmno Poland 86-200
    96 Akademii Medycznej w Bialymstoku Choroszcz Poland 16-070
    97 Wojewodzki Szpital Psychiatryczny Gdansk Poland 80-282
    98 Poradnia Zdrowia Psychicznego Kutno Poland 99-300
    99 Specjalistyczny Psychiatryczny ZOZ w Lodzi Lodz Poland 91-229
    100 Wojewodzki Szpital dla Nerwowo i Psychicznie Chorych Lubiaz Poland 56-110
    101 SP ZOZ Swietokrzyskie Centrum Psychiatrii w Morawicy Morawica Poland 26-026
    102 Wojewodzki Osrodek Lecznictwa Psychiatrycznego w Toruniu Torun Poland 87-100
    103 Wojewodzki Osrodek Lecznictwa Psychiatrycznego Torun Poland 87-100
    104 Inventiva Biomedical and Sport Research Sp. z o.o. Tuszyn Poland 95-080
    105 NZOZ Centrum Zdrowia Psychicznego Wroclaw Poland 50-541
    106 University Hospital Bratislava Bratislava Slovakia 82606
    107 Nemocnica s poliklinikou Liptovsky Mikulas Liptovsky Mikulas Slovakia 031 23
    108 General Hospital in Trencín Trencin Slovakia 911 71
    109 Westville Hospital Westville Durban South Africa 4058
    110 Vista Clinic Pretoria Gauteng South Africa 0046
    111 Westdene Research Centre Bloemfontein Republic of South Africa South Africa 9301
    112 Vista Clinic Pretoria Republic of South Africa South Africa 0046
    113 Dey Clinic Pretoria Republic of South Africa South Africa
    114 Paarl Medical Centre Paarl Western Cape South Africa 7646
    115 Knighton Surgery Cape Town South Africa 7700
    116 2B Tre Mondi Office Park Somerset West South Africa
    117 Welkom Mediclinic Welkom South Africa 9459

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01309542
    Other Study ID Numbers:
    • 3151A1-303
    • B2061069
    First Posted:
    Mar 7, 2011
    Last Update Posted:
    Apr 26, 2011
    Last Verified:
    Apr 1, 2011
    Keywords provided by , ,
    major depressive disorder
    desvenlafaxine
    antidepressant
    Additional relevant MeSH terms:
    Disease
    Depressive Disorder
    Depression
    Depressive Disorder, Major
    Desvenlafaxine Succinate

    Study Results

    No Results Posted as of Apr 26, 2011