Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD)

Completed · Phase 4 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

A multicenter, 8-week study to evaluate the efficacy of 2 doses (50 and 100 mg/day) of desvenlafaxine succinate sustained-release (DVS SR) versus placebo in adult outpatients with major depressive disorder.

Key facts

Study ID

NCT01432457

Run by

Pfizer

People needed

924

Starts

2011-10-01

Expected to finish

2012-08-01

Last updated by the study team

2014-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female outpatients aged 18 years or older who are fluent in written and spoken English.
• A primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode, without psychotic features.
• A HAM-D17 total score ≥20 at the screening and baseline (study day -1) visits and no more than a 4-point improvement from screening to baseline.

You may not qualify if…

• Significant risk of suicide based on clinical judgment.
• Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
• Current generalized anxiety disorder, panic disorder, or social anxiety disorder.
• History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs.
• Any unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.

Where it is running

• Deidcated Clinical Research — Phoenix, Arizona, United States
• Arkansas Psychiatric Clinic Clinical Research Trials, P.A. — Little Rock, Arkansas, United States
• Pacific Clinical Research Medical Group — Arcadia, California, United States
• Southwestern Research, Incorporated — Beverly Hills, California, United States
• Clinical Innovations, Inc. — Costa Mesa, California, United States
• Synergy Clinical Research of Escondido — Escondido, California, United States
• Synergy Clinical Research Center — National City, California, United States
• Pacific Research Partners — Oakland, California, United States
• Pasadena Research Institute, LLC — Pasadena, California, United States
• Clinical Innovations, Inc. — Riverside, California, United States
• Affiliated Research Institute — San Diego, California, United States
• Clinical Innovations, Inc. — San Diego, California, United States
• California Neuroscience Research Medical Group, Inc — Sherman Oaks, California, United States
• Viking Clinical Research Center — Temecula, California, United States
• Collaborative Neuroscience Network, Inc. South Bay — Torrance, California, United States
• Pacific Clinical Research Medical Group — Upland, California, United States
• Clinical Neuroscience Solutions Incorporated — Jacksonville, Florida, United States
• Accurate Clinical Trials, Inc. — Kissimmee, Florida, United States
• Florida Clinical Research Center, LLC — Maitland, Florida, United States
• Comprehensive NeuroScience, Inc. — St. Petersburg, Florida, United States
• Janus Center for Psychiatric Research — West Palm Beach, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Comprehensive NeuroScience, Incorporated — Atlanta, Georgia, United States
• Carman Research — Smyrna, Georgia, United States
• Dedicated Clinical Research — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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