You are here

Our science / Clinical Trials / Find a Trial / NCT00406640

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

Back to Search Print Save as PDF Bookmark Trial

NCT00406640

Last updated on May 10, 2018
Back to Search Print Save as PDF Bookmark Trial

FOR MORE INFORMATION
Study Location
Peoria, Arizona, 85381 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Depression, Depressive Disorder, Major Depressive Disorder
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00406640
Pfizer
Completed
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) vs. Escitalopram in Postmenopausal Women

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
Advanced Search

Similar Trials

Bipolar Disorder
Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder
NCT02075047
All Genders
10+
Years
Multiple Sites
Sickle Cell Anemia, Sickle Cell Disease, Sickle Cell Disorders, Pain Crisis, Vaso-occlusive Crisis
Safety Of Rivipansel (GMI-1070) In The Treatment Of One or More Vaso-occlusive Crises In Hospitalized Subjects With Sickle Cell Disease
NCT02433158
All Genders
6+
Years
Multiple Sites
Obsessive Compulsive Disorder
Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)
NCT01302080
All Genders
6+
Years
Multiple Sites
Major Depressive Disorder
Korean Post Marketing Surveillance to Observe Effectiveness and Safety of PRISTIQ
NCT02548949
All Genders
19+
Years
Multiple Sites
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) vs. Escitalopram in Postmenopausal Women
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Depression
  • Depressive Disorder
  • Depressive Disorder, Major
  • Drug: Desvenlafaxine succinate sustained-release (DVS SR)
    flexible dose of DVS 50-100 or 200 mg every day during 56 days. Extension until 6 months.
  • Drug: Escitalopram
    Flexible dose of Escitalopram 10 or 20 mg every day during 56 days. Extension until 6 months.
  • Active Comparator: A
    Intervention: Drug: Desvenlafaxine succinate sustained-release (DVS SR)
  • Active Comparator: B
    Intervention: Drug: Escitalopram
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
595
October 2008
February 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
40 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Chile,   Colombia,   Mexico,   Peru,   United States
 
 
NCT00406640
3151A1-402
Not Provided
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Argentina: [email protected]
Principal Investigator: Trial Manager For Chile: [email protected]
Principal Investigator: Trial Manager For Mexico: [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
May 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now