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”

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.

Study Type: Interventional

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

Study Primary Completion Date: February 2008

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
• Active Comparator: B

Primary Measures

• 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.
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• To compare DVS SR to escitalopram with respect to remission and response rates, anxiety scores, quality of life, safety, and tolerability.
  • Time Frame: 6 months
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Wyeth

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth  

Information obtained from ClinicalTrials.gov on January 08, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00406640

Study ID Number: 3151A1-402

ClinicalTrials.gov Identifier: NCT00406640

Health Authority: United States: Food and Drug Administration