Clinical trial NCT00406640: Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) vs. Escitalopram in Postmenopausal Women
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Depressive Disorder
Depressive Disorder, Major
Keywords: MDD
Major Depressive Disorder
Depression
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-12-04
Enrollment: 595
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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 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.

Primary outcomes:
measure: Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Percentage of Patients Achieving Response to Treatment at Final On-therapy Evaluation (Acute Phase)
timeFrame: 8 weeks
measure: Percentage of Patients Achieving Remission at Final On-therapy Evaluation (Acute Phase)
timeFrame: 8 weeks
measure: Clinical Global Impression Improvement (CGI-I) Score at 8 Weeks
timeFrame: 8 weeks
measure: Change in Clinical Global Impression Severity (CGI-S) Score From Baseline to Week
timeFrame: Baseline and 8 weeks
measure: Change in Hamilton Psychiatric Rating Scale for Anxiety From Baseline to Week 8 (HAM-A) Score
timeFrame: Baseline and Week 8
measure: Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8
timeFrame: Baseline and week 8
measure: Percentage of Responders Maintaining Response to Treatment at Final On-therapy Evaluation (Double Blind Continuation Phase)
timeFrame: 6 months
measure: Percentage of Responders Achieving Remission at Final On-therapy Evaluation (Double Blind Continuation Phase)
timeFrame: 6 months
measure: Percentage of Responders Improving Response to Remission During 6-month Double Blind Continuation Phase
timeFrame: 6 months
measure: Percentage of Non-Responders Achieving Response at Final Evaluation of 6-month Open-Label (OL)Extension Phase
timeFrame: 6 months
measure: Percentage of Non-Responders Achieving Remission at Final Evaluation of 6-month Open-Label Extension Phase
timeFrame: 6 months
measure: Discontinuation-Emergent Signs and Symptoms (DESS) Total Score
timeFrame: 6 months
Other outcomes:
Locations:
city: Peoria
country: United States
state: Arizona
city: Pasadena
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Cromwell
country: United States
state: Connecticut
city: Farmington
country: United States
state: Connecticut
city: Waterbury
country: United States
state: Connecticut
city: Brooksville
country: United States
state: Florida
city: Coral Springs
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Maitland
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Roswell
country: United States
state: Georgia
city: Northfield
country: United States
state: Illinois
city: Oak Brook
country: United States
state: Illinois
city: Overland Park
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: New Orleans
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Fall River
country: United States
state: Massachusetts
city: Saint Paul
country: United States
state: Minnesota
city: Las Vegas
country: United States
state: Nevada
city: Piscataway
country: United States
state: New Jersey
city: Elmsford
country: United States
state: New York
city: Hollis
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: East Providence
country: United States
state: Rhode Island
city: Lincoln
country: United States
state: Rhode Island
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Mount Pleasant
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Bellaire
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Denton
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Charlottesville
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Morgantown
country: United States
state: West Virginia
city: Middleton
country: United States
state: Wisconsin
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: La Plata
country: Argentina
city: Mendoza
country: Argentina
city: Santiago
country: Chile
city: Barranquilla
country: Colombia
city: Bogota
country: Colombia
city: Bucamaranga
country: Colombia
city: Mexico City
country: Mexico
city: Monterrey
country: Mexico
city: Tobasco
country: Mexico
city: Chiclayo
country: Peru
city: Lima
country: Peru
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Argentina: Scheima@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Chile: scheima@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Mexico: gomezzlj@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soares CN, Thase ME, Clayton A, Guico-Pabia CJ, Focht K, Jiang Q, Kornstein SG, Ninan PT, Kane CP. Open-label treatment with desvenlafaxine in postmenopausal women with major depressive disorder not responding to acute treatment with desvenlafaxine or escitalopram. CNS Drugs. 2011 Mar;25(3):227-38. doi: 10.2165/11586460-000000000-00000.