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Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) vs. Escitalopram in Postmenopausal Women

CompletedPhase 3

Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Conditions: Depression, Depressive Disorder, Depressive Disorder, Major

Interventions: Desvenlafaxine succinate sustained-release (DVS SR), Escitalopram

Countries: United States, Argentina, Chile, Colombia, Mexico, Peru

Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). This study will investigate the safety, efficacy, and tolerability of DVS SR versus escitalopram in women with major depressive disorder (MDD) who are postmenopausal.

Eligibility overview

Sex: FEMALE

Age: 40 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Postmenopausal women between the ages of 40 and 70 years, inclusive.
* A primary diagnosis of MDD, single or recurrent episode, without psychotic features using the modified MINI International Neuropsychiatric Interview (MINI).
* Montgomery-Asberg Depression Rating Scale (MADRS) total score \> or = 22 at the screening and baseline visit.

Exclusion Criteria:

* Use of oral estrogen-, progestin-, androgen-, or Selective Estrogen Receptor Modulator (SERM)-containing drug products 8 weeks before baseline.
* Current (within 12 months) psychoactive substance abuse or dependence (including alcohol), manic episode, post-traumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
* A history or active presence of clinically important medical disease.

Additional criteria apply.

Locations (70)

Peoria, Arizona, United States
Pasadena, California, United States
San Diego, California, United States
San Diego, California, United States
Denver, Colorado, United States
Cromwell, Connecticut, United States
Farmington, Connecticut, United States
Waterbury, Connecticut, United States
Brooksville, Florida, United States
Coral Springs, Florida, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Maitland, Florida, United States
Atlanta, Georgia, United States
Roswell, Georgia, United States
Northfield, Illinois, United States
Oak Brook, Illinois, United States
Overland Park, Kansas, United States
Wichita, Kansas, United States
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Fall River, Massachusetts, United States
Saint Paul, Minnesota, United States
Las Vegas, Nevada, United States
Piscataway, New Jersey, United States
Elmsford, New York, United States
Hollis, New York, United States
New York, New York, United States
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