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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00406640 |
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Date of registration:
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29/11/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) vs. Escitalopram in Postmenopausal Women
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Scientific title:
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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 |
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Date of first enrolment:
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December 2006 |
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Target sample size:
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595 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00406640 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Chile
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Colombia
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Mexico
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Peru
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United States
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Contacts
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Mexico: gomezzlj@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Chile: scheima@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Argentina: Scheima@wyeth.com |
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Key inclusion & exclusion criteria
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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.
Age minimum:
40 Years
Age maximum:
70 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Depressive Disorder
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Depression
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Depressive Disorder, Major
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Intervention(s)
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Drug: Desvenlafaxine succinate sustained-release (DVS SR)
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Drug: Escitalopram
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Primary Outcome(s)
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Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8
[Time Frame: Baseline and 8 weeks]
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Secondary Outcome(s)
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Clinical Global Impression Improvement (CGI-I) Score at 8 Weeks
[Time Frame: 8 weeks]
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Percentage of Patients Achieving Remission at Final On-therapy Evaluation (Acute Phase)
[Time Frame: 8 weeks]
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Change in Clinical Global Impression Severity (CGI-S) Score From Baseline to Week
[Time Frame: Baseline and 8 weeks]
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Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8
[Time Frame: Baseline and week 8]
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Percentage of Responders Maintaining Response to Treatment at Final On-therapy Evaluation (Double Blind Continuation Phase)
[Time Frame: 6 months]
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Change in Hamilton Psychiatric Rating Scale for Anxiety From Baseline to Week 8 (HAM-A) Score
[Time Frame: Baseline and Week 8]
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Discontinuation-Emergent Signs and Symptoms (DESS) Total Score
[Time Frame: 6 months]
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Percentage of Non-Responders Achieving Remission at Final Evaluation of 6-month Open-Label Extension Phase
[Time Frame: 6 months]
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Percentage of Patients Achieving Response to Treatment at Final On-therapy Evaluation (Acute Phase)
[Time Frame: 8 weeks]
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Percentage of Responders Improving Response to Remission During 6-month Double Blind Continuation Phase
[Time Frame: 6 months]
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Percentage of Non-Responders Achieving Response at Final Evaluation of 6-month Open-Label (OL)Extension Phase
[Time Frame: 6 months]
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Percentage of Responders Achieving Remission at Final On-therapy Evaluation (Double Blind Continuation Phase)
[Time Frame: 6 months]
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Secondary ID(s)
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3151A1-402
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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