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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Desvenlafaxine Succinate
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring major depressive disorder, desvenlafaxine, antidepressant

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Birmingham Research Group Inc.
  • Pivotal Research Centers 13128 North 94th Drive, Suite 200
  • Pivotal Research
  • Southwestern Research, Inc.
  • Feighner Research Institute
  • California Clinical Trials Medical Group, Inc.
  • Pharmacology Research Institute
  • Pacific Clinical Research
  • UCSD Department of Psychiatry Psychopharmacology Research
  • Southwestern Research, Inc.
  • Alpine Clinical Research Center, Inc.
  • Feiger Health Research Center
  • University of Connecticut Health Center
  • New Britain General Hospital
  • The George Washington University Medical Center
  • CORE Research, Inc.1006 NW 14
  • Lifestream Behavioral Center
  • Clinical Neuroscience Solutions, Inc.
  • Miami Research Associates, Inc.
  • Comprehensive NeuroScience, Inc.
  • Kolin Research Group 1065 West Morse Blvd. Suite 202
  • Atlanta Center for Medical Research
  • Atlanta Institute of Medicine & Research
  • Carman Research
  • Radiant Research - Chicago
  • Ingenium Clinical Research
  • Capital Clinical Research Associates, LLP
  • DuPont Clinical Research, Inc.
  • Institute for Health Studies
  • Creighton University
  • Center for Emotional Fitness
  • CRI Worldwide, LLC
  • Anxiety & Depression Clinic
  • Social Psychiatry Research Institute
  • The Medical Research Network
  • Piedmont Neuropsychiatry
  • Hartford Research Group
  • Midwest Clinical Research Center, LLC
  • Neurology & Neuroscience Center of Ohio
  • IPS Research Company
  • Summit Research Network (Oregon), Inc.
  • Southeastern Pennsylvania Medical Institute
  • RI Mood & Memory Research Institute
  • Southeast Health Consultants, LLC
  • Carolina Clinical Research Services
  • FutureSearch Trials
  • University of Texas Southwestern
  • Research Testing, Inc.
  • Radiant Research Salt Lake City
  • Northwest Clinical Research Center
  • Summit Research Network (Seattle) LLC
  • Center for Anxiety and Depression
  • Northbrooke Research Center
  • West Tallinn Central Hospital
  • Jaanson-Lääne Outpatient Clinic
  • Viljandi Hospital Foundation Psychiatric Clinic
  • Psykiatripalvelu AT Oy
  • FF Research
  • Mehilainen clinic
  • Mehiläinen, HUCH
  • Hakaniemen Lääkäriasema
  • Psychiatric Research Clinic of Kupio
  • Satakunnanpsykiatripalvelu
  • MediRoi Oy
  • Psychiatric Research clinic of Salo
  • Psykoforum OY
  • Länsi-Suomen Erikoislaakaripalvelu Oy
  • Turku Psychiatric Services Aurakatu 14 B 3 Krs
  • Klinicko-bolnicki centar Dr Dragisa Misovic - Dedinje
  • Institut za mentalno zdravlje
  • 1, avenue du 6 Juin
  • 88 Rue Emmanuel Liais
  • Centre Médico-Psychologique
  • Résidence St Michel
  • 57 rue Gamard
  • Immeuble Impérial
  • 16 avenue Robert Schuman
  • 3 rue Marceau
  • Office of Dr Marce Zins-Ritter
  • 22 rue de Nemours
  • 7, rue Georges Politzer
  • 13 place Gaston Paillhou
  • emovis GmbH
  • Praxis fuer Psychiatrie, Dr. Franz
  • Praxis für Psychiatrie, Dr. Alexander Schulze
  • Psychiatrische Praxis Dr. Hans-Peter Wunderlich
  • Praxis f. Neurologie u. Psychiatrie Dr. Lutz D. Lohse
  • Dr. D. Backhaus, Hildesheim
  • Psychoneurological hospital of Jelgava, Dept No12
  • Riga Mental Health Care Center, Dept of Psychiatry
  • Strenci Psychiatric Hospital
  • Medical center Neuromeda
  • Klaipeda Psychiatry Hospital
  • Vilnius Mental Health Care
  • Poradnia Zdrowia Psychicznego w Chelmnie
  • Akademii Medycznej w Bialymstoku
  • Wojewodzki Szpital Psychiatryczny
  • Poradnia Zdrowia Psychicznego
  • Specjalistyczny Psychiatryczny ZOZ w Lodzi
  • Wojewodzki Szpital dla Nerwowo i Psychicznie Chorych
  • SP ZOZ Swietokrzyskie Centrum Psychiatrii w Morawicy
  • Wojewodzki Osrodek Lecznictwa Psychiatrycznego w Toruniu
  • Wojewodzki Osrodek Lecznictwa Psychiatrycznego
  • Inventiva Biomedical and Sport Research Sp. z o.o.
  • NZOZ Centrum Zdrowia Psychicznego
  • University Hospital Bratislava
  • Nemocnica s poliklinikou Liptovsky Mikulas
  • General Hospital in Trencín
  • Westville Hospital
  • Vista Clinic
  • Westdene Research Centre
  • Vista Clinic
  • Dey Clinic
  • Paarl Medical Centre
  • Knighton Surgery
  • 2B Tre Mondi Office Park
  • Welkom Mediclinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DVS

Arm Description

Outcomes

Primary Outcome Measures

Number (%) of Subjects Reporting Adverse Events during Treatment
Number (%) of Subjects With Changes in Vital Signs (Blood Pressure, Pulse Rate, Weight) of Potential Clinical Importance
Number (%) of Subjects With Laboratory Test Results (Hematology, Blood Chemistry, Lipid Profile, Urinalysis) of Potential Clinical Importance
Number (%) of Subjects With Electrocardiogram Results (Heart Rate, QTc interval) of Potential Clinical Importance

Secondary Outcome Measures

Change in Hamilton Depression Rating scale - 17 items version - (HAM-D17) mean score from baseline
Change in Montgomery Asberg Depression Rating Scale (MADRS)mean score from baseline
Change in Clinical Global Improvement Scale-Severity (CGI-S)mean score from baseline

Full Information

First Posted
February 24, 2011
Last Updated
April 22, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01309542
Brief Title
Long-Term Safety Of DVS-233 SR In Patients With Major Depressive Disorder
Official Title
A 10 Month Open-Label Evaluation Of The Long-Term Safety Of DVS-233 SR In Outpatients With Major Depressive Disorder.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
major depressive disorder, desvenlafaxine, antidepressant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1403 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DVS
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Desvenlafaxine Succinate
Other Intervention Name(s)
DVS-233 SR
Intervention Description
Tablet were taken at a daily dose of 200 to 400 mg/day for a duration up to 10 months
Primary Outcome Measure Information:
Title
Number (%) of Subjects Reporting Adverse Events during Treatment
Time Frame
10 months
Title
Number (%) of Subjects With Changes in Vital Signs (Blood Pressure, Pulse Rate, Weight) of Potential Clinical Importance
Time Frame
10 months
Title
Number (%) of Subjects With Laboratory Test Results (Hematology, Blood Chemistry, Lipid Profile, Urinalysis) of Potential Clinical Importance
Time Frame
10 months
Title
Number (%) of Subjects With Electrocardiogram Results (Heart Rate, QTc interval) of Potential Clinical Importance
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Change in Hamilton Depression Rating scale - 17 items version - (HAM-D17) mean score from baseline
Time Frame
10 months
Title
Change in Montgomery Asberg Depression Rating Scale (MADRS)mean score from baseline
Time Frame
10 months
Title
Change in Clinical Global Improvement Scale-Severity (CGI-S)mean score from baseline
Time Frame
10 months

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
21977353
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3151A1-303&StudyName=Long-Term%20Safety%20Of%20DVS-233%20SR%20In%20Patients%20With%20Major%20Depressive%20Disorder
Description
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Learn more about this trial

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

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