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.

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).

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Desvenlafaxine Succinate

• Study Type: Interventional
• Enrollment (Actual): 1403
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: August 1, 2003
• Primary Completion (Actual): March 1, 2006
• Study Completion (Actual): March 1, 2006

Study Registration Dates

• First Submitted: February 24, 2011
• First Submitted That Met QC Criteria: March 3, 2011
• First Posted (Estimate): March 7, 2011

Study Record Updates

• Last Update Posted (Estimate): April 26, 2011
• Last Update Submitted That Met QC Criteria: April 22, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: major depressive disorder; antidepressant; desvenlafaxine
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Desvenlafaxine Succinate
• Other Study ID Numbers: 3151A1-303; B2061069