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

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NCT00406640

Last updated on May 10, 2018
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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

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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

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