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

Condition(s) targeted: Depression; Depressive Disorder; Depressive Disorder, Major

Intervention: Desvenlafaxine succinate sustained-release (DVS SR) (Drug); Escitalopram (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Trial Manager, Principal Investigator, Affiliation: For Argentina: Scheima@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Chile: scheima@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Mexico: gomezzlj@wyeth.com

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.

Official title: A Multicenter, Randomized, 8-Week Double-Blind Acute Phase Followed By a 6-Month Continuation Phase (Open-Label Or Double-Blind) Study to Evaluate the Efficacy, Safety, and Tolerability of DVS SR Versus Escitalopram in Postmenopausal Women With Major Depressive Disorder

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: To assess efficacy measured by the change from baseline on the Hamilton Rating Scale for Depression total score over 8 weeks of treatment with DVS SR compared to treatment with escitalopram in postmenopausal women with MDD.

Secondary outcome: To compare DVS SR to escitalopram with respect to remission and response rates, anxiety scores, quality of life, safety, and tolerability.

Minimum age: 40 Years. Maximum age: 70 Years. Gender(s): Female.

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.

Buenos Aires 1221, Argentina

Buenos Aires 1062, Argentina

Buenos Aires 1119, Argentina

Buenos Aires 1425, Argentina

Buenos Aires 1414, Argentina

Buenos Aires 1126, Argentina

Mendoza 5500, Argentina

Buenos Aires 1205, Argentina

La Plata 1900, Argentina

Santiago, Chile

Bogota, Colombia

Barranquilla, Colombia

Bucamaranga, Colombia

Mexico City, Mexico

Monterrey, Mexico

Tobasco, Mexico

Chiclayo, Peru

Lima, Peru

Peoria, Arizona 85381, United States

San Diego, California 92108, United States

San Diego, California 92103, United States

Pasadena, California 91107, United States

Denver, Colorado 80212, United States

Waterbury, Connecticut 06708, United States

Farmington, Connecticut 06030, United States

Cromwell, Connecticut 06416, United States

Brooksville, Florida 34613, United States

Coral Springs, Florida 33065, United States

Fort Meyers, Florida 33912, United States

Gainesville, Florida 32607, United States

Maitland, Florida 32751, United States

Roswell, Georgia 30076, United States

Atlanta, Georgia 30328, United States

Atlanta, Georgia 30328, United States

Northfield, Illinois 60093, United States

Oak Brook, Illinois 60523, United States

Overland Park, Kansas 66211, United States

Witchita, Kansas 67214, United States

New Orleans, Louisiana 70115, United States

Shreveport, Louisiana 71130, United States

Baltimore, Maryland 21208, United States

Boston, Massachusetts 02114, United States

Fall River, Massachusetts 02721, United States

St. Paul, Minnesota 55101, United States

Las Vegas, Nevada 89106, United States

Piscataway, New Jersey 08854, United States

New York, New York 10128, United States

New York, New York 10032, United States

Syracuse, New York 13210, United States

Holliswood, New York 11423, United States

Elmsford, New York 10523, United States

Raleigh, North Carolina 27612, United States

Oklahoma City, Oklahoma 73103, United States

Pittsburgh, Pennsylvania 15206, United States

Philadelphia, Pennsylvania 19104, United States

Pittsburgh, Pennsylvania 15213, United States

Lincoln, Rhode Island 02865, United States

East Providence, Rhode Island 02914, United States

Mt. Pleasant, South Carolina 29464, United States

Columbia, South Carolina 29201, United States

Charleston, South Carolina 29407, United States

Memphis, Tennessee 38117, United States

Houston, Texas 77090, United States

Bellaire, Texas 77401, United States

Dallas, Texas 75235, United States

Denton, Texas 76201, United States

Burlington, Vermont 05401, United States

Charlottesville, Virginia 22903, United States

Richmond, Virginia 23230, United States

Morgantown, West Virginia 26506, United States

Middleton, Wisconsin 53562, United States

Starting date: December 2006
Ending date: October 2008
Last updated: December 19, 2007