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

Completed · Phase 3

Conditions studied: Major Depressive Disorder

In brief

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).

Key facts

Study ID

NCT01309542

Run by

Pfizer

People needed

1403

Starts

2003-08-01

Expected to finish

2006-03-01

Last updated by the study team

2011-04-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Pivotal Research Centers 13128 North 94th Drive, Suite 200 — Mesa, Arizona, United States
• Pivotal Research — Peoria, Arizona, United States
• Southwestern Research, Inc. — Beverly Hills, California, United States
• Feighner Research Institute — Chula Vista, California, United States
• California Clinical Trials Medical Group, Inc. — Glendale, California, United States
• Pharmacology Research Institute — Newport Beach, California, United States
• Pacific Clinical Research — Orange, California, United States
• UCSD Department of Psychiatry Psychopharmacology Research — San Diego, California, United States
• Southwestern Research, Inc. — Tustin, California, United States
• Alpine Clinical Research Center, Inc. — Boulder, Colorado, United States
• Feiger Health Research Center — Lakewood, Colorado, United States
• University of Connecticut Health Center — Farmington, Connecticut, United States
• New Britain General Hospital — New Britain, Connecticut, United States
• The George Washington University Medical Center — Washington D.C., District of Columbia, United States
• CORE Research, Inc.1006 NW 14 — Leesburg, Florida, United States
• Lifestream Behavioral Center — Leesburg, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
• Miami Research Associates, Inc. — South Miami, Florida, United States
• Comprehensive NeuroScience, Inc. — St. Petersburg, Florida, United States
• Kolin Research Group 1065 West Morse Blvd. Suite 202 — Winter Park, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Atlanta Institute of Medicine & Research — Marietta, Georgia, United States
• Carman Research — Smyrna, Georgia, United States
• Radiant Research - Chicago — Chicago, Illinois, United States
• Birmingham Research Group Inc. — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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