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

Major Depressive Disorder Clinical Trial

Official title:

A 10 Month Open-Label Evaluation Of The Long-Term Safety Of DVS-233 SR In Outpatients With Major Depressive Disorder.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01309542
• Other study ID #: 3151A1-303
• Secondary ID: B2061069
• Status: Completed
• Phase: Phase 3
• First received: February 24, 2011
• Last updated: April 22, 2011
• Start date: August 2003
• Est. completion date: March 2006

Study information

• Verified date: April 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1403
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Desvenlafaxine Succinate
Tablet were taken at a daily dose of 200 to 400 mg/day for a duration up to 10 months

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Estonia,  Finland,  Former Serbia and Montenegro,  France,  Germany,  Latvia,  Lithuania,  Poland,  Slovakia,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number (%) of Subjects Reporting Adverse Events during Treatment		10 months	Yes
Primary	Number (%) of Subjects With Changes in Vital Signs (Blood Pressure, Pulse Rate, Weight) of Potential Clinical Importance		10 months	Yes
Primary	Number (%) of Subjects With Laboratory Test Results (Hematology, Blood Chemistry, Lipid Profile, Urinalysis) of Potential Clinical Importance		10 months	Yes
Primary	Number (%) of Subjects With Electrocardiogram Results (Heart Rate, QTc interval) of Potential Clinical Importance		10 months	Yes
Secondary	Change in Hamilton Depression Rating scale - 17 items version - (HAM-D17) mean score from baseline		10 months	No
Secondary	Change in Montgomery Asberg Depression Rating Scale (MADRS)mean score from baseline		10 months	No
Secondary	Change in Clinical Global Improvement Scale-Severity (CGI-S)mean score from baseline		10 months	No

External Links

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