Clinical trial NCT01309542: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: major depressive disorder
desvenlafaxine
antidepressant
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-03-07
Enrollment: 1403
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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).

Primary outcomes:
measure: Number (%) of Subjects Reporting Adverse Events during Treatment
timeFrame: 10 months
measure: Number (%) of Subjects With Changes in Vital Signs (Blood Pressure, Pulse Rate, Weight) of Potential Clinical Importance
timeFrame: 10 months
measure: Number (%) of Subjects With Laboratory Test Results (Hematology, Blood Chemistry, Lipid Profile, Urinalysis) of Potential Clinical Importance
timeFrame: 10 months
measure: Number (%) of Subjects With Electrocardiogram Results (Heart Rate, QTc interval) of Potential Clinical Importance
timeFrame: 10 months
Secondary outcomes:
measure: Change in Hamilton Depression Rating scale - 17 items version - (HAM-D17) mean score from baseline
timeFrame: 10 months
measure: Change in Montgomery Asberg Depression Rating Scale (MADRS)mean score from baseline
timeFrame: 10 months
measure: Change in Clinical Global Improvement Scale-Severity (CGI-S)mean score from baseline
timeFrame: 10 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Research Group Inc.
state: Alabama
city: Mesa
country: United States
facility: Pivotal Research Centers 13128 North 94th Drive, Suite 200
state: Arizona
city: Peoria
country: United States
facility: Pivotal Research
state: Arizona
city: Beverly Hills
country: United States
facility: Southwestern Research, Inc.
state: California
city: Chula Vista
country: United States
facility: Feighner Research Institute
state: California
city: Glendale
country: United States
facility: California Clinical Trials Medical Group, Inc.
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: Orange
country: United States
facility: Pacific Clinical Research
state: California
city: San Diego
country: United States
facility: UCSD Department of Psychiatry Psychopharmacology Research
state: California
city: Tustin
country: United States
facility: Southwestern Research, Inc.
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research Center, Inc.
state: Colorado
city: Lakewood
country: United States
facility: Feiger Health Research Center
state: Colorado
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: New Britain
country: United States
facility: New Britain General Hospital
state: Connecticut
city: Washington
country: United States
facility: The George Washington University Medical Center
state: District of Columbia
city: Leesburg
country: United States
facility: CORE Research, Inc.1006 NW 14
state: Florida
city: Leesburg
country: United States
facility: Lifestream Behavioral Center
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates, Inc.
state: Florida
city: St. Petersburg
country: United States
facility: Comprehensive NeuroScience, Inc.
state: Florida
city: Winter Park
country: United States
facility: Kolin Research Group 1065 West Morse Blvd. Suite 202
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Marietta
country: United States
facility: Atlanta Institute of Medicine & Research
state: Georgia
city: Smyrna
country: United States
facility: Carman Research
state: Georgia
city: Chicago
country: United States
facility: Radiant Research - Chicago
state: Illinois
city: Libertyville
country: United States
facility: Ingenium Clinical Research
state: Illinois
city: Rockville
country: United States
facility: Capital Clinical Research Associates, LLP
state: Maryland
city: Rockville
country: United States
facility: DuPont Clinical Research, Inc.
state: Maryland
city: Okemos
country: United States
facility: Institute for Health Studies
state: Michigan
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness
state: New Jersey
city: Clementon
country: United States
facility: CRI Worldwide, LLC
state: New Jersey
city: Bronx
country: United States
facility: Anxiety & Depression Clinic
state: New York
city: New York
country: United States
facility: Social Psychiatry Research Institute
state: New York
city: New York
country: United States
facility: The Medical Research Network
state: New York
city: Charlotte
country: United States
facility: Piedmont Neuropsychiatry
state: North Carolina
city: Cincinatti
country: United States
facility: Hartford Research Group
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center, LLC
state: Ohio
city: Toledo
country: United States
facility: Neurology & Neuroscience Center of Ohio
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network (Oregon), Inc.
state: Oregon
city: Havertown
country: United States
facility: Southeastern Pennsylvania Medical Institute
state: Pennsylvania
city: East Providence
country: United States
facility: RI Mood & Memory Research Institute
state: Rhode Island
city: Charleston
country: United States
facility: Southeast Health Consultants, LLC
state: South Carolina
city: Columbia
country: United States
facility: Carolina Clinical Research Services
state: South Carolina
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Houston
country: United States
facility: Research Testing, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: Radiant Research Salt Lake City
state: Utah
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Summit Research Network (Seattle) LLC
state: Washington
city: Seattle
country: United States
facility: Center for Anxiety and Depression
state: Washington
city: Brown Deer
country: United States
facility: Northbrooke Research Center
state: Wisconsin
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital
city: Tartu
country: Estonia
facility: Jaanson-Lääne Outpatient Clinic
city: Viljandi
country: Estonia
facility: Viljandi Hospital Foundation Psychiatric Clinic
city: Espoo
country: Finland
facility: Psykiatripalvelu AT Oy
city: Helsinki
country: Finland
facility: FF Research
city: Helsinki
country: Finland
facility: Mehilainen clinic
city: Helsinki
country: Finland
facility: Mehiläinen, HUCH
city: Helsinki
country: Finland
facility: Hakaniemen Lääkäriasema
city: Kuopio
country: Finland
facility: Psychiatric Research Clinic of Kupio
city: Rauma
country: Finland
facility: Satakunnanpsykiatripalvelu
city: Rovaniemi
country: Finland
facility: MediRoi Oy
city: Salo
country: Finland
facility: Psychiatric Research clinic of Salo
city: Tampere
country: Finland
facility: Psykoforum OY
city: Turku
country: Finland
facility: Länsi-Suomen Erikoislaakaripalvelu Oy
city: Turku
country: Finland
facility: Turku Psychiatric Services Aurakatu 14 B 3 Krs
city: Belgrade
country: Former Serbia and Montenegro
facility: Klinicko-bolnicki centar Dr Dragisa Misovic - Dedinje
city: Beograd
country: Former Serbia and Montenegro
facility: Institut za mentalno zdravlje
city: Caen
country: France
facility: 1, avenue du 6 Juin
city: Cherbourg
country: France
facility: 88 Rue Emmanuel Liais
city: Dole
country: France
facility: Centre Médico-Psychologique
city: Douai
country: France
facility: Résidence St Michel
city: Joué-Les-Tours
country: France
facility: 57 rue Gamard
city: La Valette du Var
country: France
facility: Immeuble Impérial
city: Mulhouse
country: France
facility: 16 avenue Robert Schuman
city: Nantes
country: France
facility: 3 rue Marceau
city: Orvault
country: France
facility: Office of Dr Marce Zins-Ritter
city: Rennes
country: France
facility: 22 rue de Nemours
city: Saint Cyr l'Ecole
country: France
facility: 7, rue Georges Politzer
city: Tours
country: France
facility: 13 place Gaston Paillhou
city: Berlin
country: Germany
facility: emovis GmbH
city: Berlin
country: Germany
facility: Praxis fuer Psychiatrie, Dr. Franz
city: Berlin
country: Germany
facility: Praxis für Psychiatrie, Dr. Alexander Schulze
city: Dresden
country: Germany
facility: Psychiatrische Praxis Dr. Hans-Peter Wunderlich
city: Dresden
country: Germany
facility: Praxis f. Neurologie u. Psychiatrie Dr. Lutz D. Lohse
city: Hildesheim
country: Germany
facility: Dr. D. Backhaus, Hildesheim
city: Jelgava
country: Latvia
facility: Psychoneurological hospital of Jelgava, Dept No12
city: Riga
country: Latvia
facility: Riga Mental Health Care Center, Dept of Psychiatry
city: Strenci
country: Latvia
facility: Strenci Psychiatric Hospital
city: Kaunas
country: Lithuania
facility: Medical center Neuromeda
city: Klaipeda
country: Lithuania
facility: Klaipeda Psychiatry Hospital
city: Vilnius
country: Lithuania
facility: Vilnius Mental Health Care
city: Chelmno
country: Poland
facility: Poradnia Zdrowia Psychicznego w Chelmnie
city: Choroszcz
country: Poland
facility: Akademii Medycznej w Bialymstoku
city: Gdansk
country: Poland
facility: Wojewodzki Szpital Psychiatryczny
city: Kutno
country: Poland
facility: Poradnia Zdrowia Psychicznego
city: Lodz
country: Poland
facility: Specjalistyczny Psychiatryczny ZOZ w Lodzi
city: Lubiaz
country: Poland
facility: Wojewodzki Szpital dla Nerwowo i Psychicznie Chorych
city: Morawica
country: Poland
facility: SP ZOZ Swietokrzyskie Centrum Psychiatrii w Morawicy
city: Torun
country: Poland
facility: Wojewodzki Osrodek Lecznictwa Psychiatrycznego w Toruniu
city: Torun
country: Poland
facility: Wojewodzki Osrodek Lecznictwa Psychiatrycznego
city: Tuszyn
country: Poland
facility: Inventiva Biomedical and Sport Research Sp. z o.o.
city: Wroclaw
country: Poland
facility: NZOZ Centrum Zdrowia Psychicznego
city: Bratislava
country: Slovakia
facility: University Hospital Bratislava
city: Liptovsky Mikulas
country: Slovakia
facility: Nemocnica s poliklinikou Liptovsky Mikulas
city: Trencin
country: Slovakia
facility: General Hospital in Trencín
city: Westville
country: South Africa
facility: Westville Hospital
state: Durban
city: Pretoria
country: South Africa
facility: Vista Clinic
state: Gauteng
city: Bloemfontein
country: South Africa
facility: Westdene Research Centre
state: Republic of South Africa
city: Pretoria
country: South Africa
facility: Vista Clinic
state: Republic of South Africa
city: Pretoria
country: South Africa
facility: Dey Clinic
state: Republic of South Africa
city: Paarl
country: South Africa
facility: Paarl Medical Centre
state: Western Cape
city: Cape Town
country: South Africa
facility: Knighton Surgery
city: Somerset West
country: South Africa
facility: 2B Tre Mondi Office Park
city: Welkom
country: South Africa
facility: Welkom Mediclinic
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.