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Major Depressive DisorderPhase 3NCT01309542

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

A Phase 3 study testing Desvenlafaxine Succinate in people with Major Depressive Disorder, run by Pfizer at 117 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Major Depressive Disorder
What is being tested?
Desvenlafaxine Succinate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,403 participants
Where
117 sitesin 11 countries
Study dates
Aug 2003to Mar 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

117 sites in 11 countries.

117 sites in 11 countries

United States53 sites

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30308

  • FutureSearch Trials

    Austin, Texas, 78756

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Southwestern Research, Inc.

    Beverly Hills, California, 90210

  • Birmingham Research Group Inc.

    Birmingham, Alabama, 35216

  • Alpine Clinical Research Center, Inc.

    Boulder, Colorado, 80304

  • Northbrooke Research Center

    Brown Deer, Wisconsin, 53223

  • Southeast Health Consultants, LLC

    Charleston, South Carolina, 29407

  • Piedmont Neuropsychiatry

    Charlotte, North Carolina, 28226

  • Center for Emotional Fitness

    Cherry Hill, New Jersey, 08002

  • Radiant Research - Chicago

    Chicago, Illinois, 60610

  • Feighner Research Institute

    Chula Vista, California, 91910

  • Hartford Research Group

    Cincinnati, Ohio, 45242

  • CRI Worldwide, LLC

    Clementon, New Jersey, 08021

  • Carolina Clinical Research Services

    Columbia, South Carolina, 29201

  • University of Texas Southwestern

    Dallas, Texas, 75235

  • Midwest Clinical Research Center, LLC

    Dayton, Ohio, 45408

  • RI Mood & Memory Research Institute

    East Providence, Rhode Island, 02914

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030-6415

  • California Clinical Trials Medical Group, Inc.

    Glendale, California, 91206

  • Southeastern Pennsylvania Medical Institute

    Havertown, Pennsylvania, 19083

  • Research Testing, Inc.

    Houston, Texas, 77004

  • Feiger Health Research Center

    Lakewood, Colorado, 80401

  • CORE Research, Inc.1006 NW 14

    Leesburg, Florida, 34748

  • Lifestream Behavioral Center

    Leesburg, Florida, 34748

  • Ingenium Clinical Research

    Libertyville, Illinois, 60048

  • Atlanta Institute of Medicine & Research

    Marietta, Georgia, 30060

  • Pivotal Research Centers 13128 North 94th Drive, Suite 200

    Mesa, Arizona, 85210

  • New Britain General Hospital

    New Britain, Connecticut, 06050

  • Social Psychiatry Research Institute

    New York, New York, 10021

  • The Medical Research Network

    New York, New York, 10024

  • Pharmacology Research Institute

    Newport Beach, California, 92660

  • Institute for Health Studies

    Okemos, Michigan, 48864

  • IPS Research Company

    Oklahoma City, Oklahoma, 73103

  • Creighton University

    Omaha, Nebraska, 68131

  • Pacific Clinical Research

    Orange, California, 92868

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32819

  • Pivotal Research

    Peoria, Arizona, 85381

  • Summit Research Network (Oregon), Inc.

    Portland, Oregon, 97210

  • Capital Clinical Research Associates, LLP

    Rockville, Maryland, 20852

  • DuPont Clinical Research, Inc.

    Rockville, Maryland, 20852

  • Radiant Research Salt Lake City

    Salt Lake City, Utah, 84107

  • UCSD Department of Psychiatry Psychopharmacology Research

    San Diego, California, 92103

  • Summit Research Network (Seattle) LLC

    Seattle, Washington, 98104

  • Center for Anxiety and Depression

    Seattle, Washington, 98105

  • Carman Research

    Smyrna, Georgia, 30080

  • Miami Research Associates, Inc.

    South Miami, Florida, 33143

  • Comprehensive NeuroScience, Inc.

    St. Petersburg, Florida, 33702

  • Anxiety & Depression Clinic

    The Bronx, New York, 10467

  • Neurology & Neuroscience Center of Ohio

    Toledo, Ohio, 43623

  • Southwestern Research, Inc.

    Tustin, California, 92780

  • The George Washington University Medical Center

    Washington D.C., District of Columbia, 20037

  • Kolin Research Group 1065 West Morse Blvd. Suite 202

    Winter Park, Florida, 32789

Other trials in United States

Finland12 sites

  • Psykiatripalvelu AT Oy

    Espoo, 02600

  • FF Research

    Helsinki, 00180

  • Mehilainen clinic

    Helsinki, 00260

  • Mehiläinen, HUCH

    Helsinki, 00260

  • Hakaniemen Lääkäriasema

    Helsinki, 00530

  • Psychiatric Research Clinic of Kupio

    Kuopio, Finland, 70110

  • Satakunnanpsykiatripalvelu

    Rauma, 26100

  • MediRoi Oy

    Rovaniemi, 96100

  • Psychiatric Research clinic of Salo

    Salo, 24100

  • Psykoforum OY

    Tampere, Finland, SF-33200

  • Länsi-Suomen Erikoislaakaripalvelu Oy

    Turku, SF-20100

  • Turku Psychiatric Services Aurakatu 14 B 3 Krs

    Turku, SF-20100

Other trials in Finland

France12 sites

  • 1, avenue du 6 Juin

    Caen, 14000

  • 88 Rue Emmanuel Liais

    Cherbourg, 50100

  • Centre Médico-Psychologique

    Dole, 39100

  • Résidence St Michel

    Douai, 59500

  • 57 rue Gamard

    Joué-Les-Tours, France, 37300

  • Immeuble Impérial

    La Valette-du-Var, 83160

  • 16 avenue Robert Schuman

    Mulhouse, 68100

  • 3 rue Marceau

    Nantes, 44000

  • Office of Dr Marce Zins-Ritter

    Orvault, 44700

  • 22 rue de Nemours

    Rennes, 35000

  • 7, rue Georges Politzer

    Saint-Cyr-l'École, 78210

  • 13 place Gaston Paillhou

    Tours, 37000

Other trials in France

Poland11 sites

  • Poradnia Zdrowia Psychicznego w Chelmnie

    Chełmno, 86-200

  • Akademii Medycznej w Bialymstoku

    Choroszcz, 16-070

  • Wojewodzki Szpital Psychiatryczny

    Gdansk, 80-282

  • SP ZOZ Swietokrzyskie Centrum Psychiatrii w Morawicy

    Gmina Morawica, Poland, 26-026

  • Poradnia Zdrowia Psychicznego

    Kutno, 99-300

  • Specjalistyczny Psychiatryczny ZOZ w Lodzi

    Lodz, 91-229

  • Wojewodzki Szpital dla Nerwowo i Psychicznie Chorych

    Lubiąż, 56-110

  • Wojewodzki Osrodek Lecznictwa Psychiatrycznego w Toruniu

    Torun, 87-100

  • Wojewodzki Osrodek Lecznictwa Psychiatrycznego

    Torun, 87-100

  • Inventiva Biomedical and Sport Research Sp. z o.o.

    Tuszyn, 95-080

  • NZOZ Centrum Zdrowia Psychicznego

    Wroclaw, 50-541

Other trials in Poland

South Africa9 sites

  • Westdene Research Centre

    Bloemfontein, Republic of South Africa, 9301

  • Knighton Surgery

    Cape Town, 7700

  • Paarl Medical Centre

    Paarl, Western Cape, 7646

  • Vista Clinic

    Pretoria, Gauteng, 0046

  • Vista Clinic

    Pretoria, Republic of South Africa, 0046

  • Dey Clinic

    Pretoria, Republic of South Africa

  • 2B Tre Mondi Office Park

    Somerset West

  • Welkom Mediclinic

    Welkom, 9459

  • Westville Hospital

    Westville, Durban, 4058

Other trials in South Africa

Germany6 sites

  • emovis GmbH

    Berlin, 10629

  • Praxis fuer Psychiatrie, Dr. Franz

    Berlin, 13053

  • Praxis für Psychiatrie, Dr. Alexander Schulze

    Berlin, D-13156

  • Psychiatrische Praxis Dr. Hans-Peter Wunderlich

    Dresden, 01097

  • Praxis f. Neurologie u. Psychiatrie Dr. Lutz D. Lohse

    Dresden, 01139

  • Dr. D. Backhaus, Hildesheim

    Hildesheim, 31134

Other trials in Germany

Estonia3 sites

  • West Tallinn Central Hospital

    Tallinn, Estonia, 126 18

  • Jaanson-Lääne Outpatient Clinic

    Tartu, Estonia, 50407

  • Viljandi Hospital Foundation Psychiatric Clinic

    Viljandi, Estonia, 71024

Other trials in Estonia

Latvia3 sites

  • Psychoneurological hospital of Jelgava, Dept No12

    Jelgava, Latvia, 3008

  • Riga Mental Health Care Center, Dept of Psychiatry

    Riga, Latvia, 1005

  • Strenci Psychiatric Hospital

    Strenči, Latvia, 4730

Other trials in Latvia

Lithuania3 sites

  • Medical center Neuromeda

    Kaunas, Lithuania, 3000

  • Klaipeda Psychiatry Hospital

    Klaipėda, Lithuania, 91251

  • Vilnius Mental Health Care

    Vilnius, Lithuania, 10309

Other trials in Lithuania

Slovakia3 sites

  • University Hospital Bratislava

    Bratislava, 82606

  • Nemocnica s poliklinikou Liptovsky Mikulas

    Liptovský Mikuláš, 031 23

  • General Hospital in Trencín

    Trenčín, 911 71

Other trials in Slovakia

Serbia and Montenegro2 sites

  • Klinicko-bolnicki centar Dr Dragisa Misovic - Dedinje

    Belgrade

  • Institut za mentalno zdravlje

    Beograd, 11000

Other trials in Serbia and Montenegro

About this study

Official title: 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).

Being tested
Desvenlafaxine Succinate
Keywords
major depressive disorder, desvenlafaxine, antidepressant
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Desvenlafaxine SuccinateDrug

    Also called DVS-233 SR

    Tablet were taken at a daily dose of 200 to 400 mg/day for a duration up to 10 months

Study groups in NCT01309542
Study groupRoleWhat they receive
DVSExperimentalNot described
Receives: Drug: Desvenlafaxine Succinate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number (%) of Subjects Reporting Adverse Events during Treatment

    Measured: 10 months

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

    Measured: 10 months

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

    Measured: 10 months

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

    Measured: 10 months

Secondary outcomes (3)

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

    Measured: 10 months

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

    Measured: 10 months

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

    Measured: 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2011 (estimated)
  2. Study startAug 2003
  3. Primary completionMar 2006
  4. Study completionMar 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1,403 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01309542
Sponsor's protocol ID
3151A1-303
Other IDs
B2061069
Status last verified
Apr 2011
First submitted
24 Feb 2011
Last updated
26 Apr 2011
Results posted
No
Data monitoring committee
No

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.

    PubMed 21977353

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Desvenlafaxine Succinate in people with Major Depressive Disorder, run by Pfizer at 117 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in United States, Finland, France, Poland, South Africa and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number (%) of Subjects Reporting Adverse Events during Treatment (time frame: 10 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01309542, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2011.

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