Phase III study evaluating Effexor XR in elderly patients with major depression.
..Date First Received: September 12, 2005
Last Updated: May 25, 2007
Verified by: Wyeth, May 2007
Clinical Trial Phase: Phase 3 | Start Date: December 2003
Overall Status: Completed
Estimated Enrollment: 100
Brief Summary
Official Title: “Phase III Study of Effexor XR for the Treatment of Elderly Patients With Depression”
Condition Keyword(s):
Additional Keyword(s) Provided by Sponsor:
Intervention(s):
Condition MeSH Term(s), Assigned with an Experimental Algorithm:
Intervention MeSH Term(s), Assigned with an Experimental Algorithm:
Phase III study evaluating Effexor XR in elderly patients with major depression.
Study Type: Interventional
Study Design: Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Intervention(s) in this Clinical Trial
- Drug: Effexor XR
Outcome Measures for this Clinical Trial
Primary Measures
- Response rate of HAM-D17 (Hamilton Rating Scale for Depression) at the final-on-therapy
Secondary Measures
- Difference of total score of HAM-D17 between baseline and final-on-therapy
- Remission rate of HAM-D17 at the final-on-therapy
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patients diagnosed with major depression based on DSM-IV-TR
- Patients having minimal total score of 18 on the HAM-D17 and minimal score of 2 on the item of "depressed mood" of HAM-D at baseline
Exclusion Criteria:
- Patients with schizophrenia or any other psychotic disorder
- Patients with history or presence of bipolar disorder
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 65 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Wyeth
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Wyeth
Additional Information
Information obtained from ClinicalTrials.gov on September 07, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00225485
Study ID Number: 0600B1-817
ClinicalTrials.gov Identifier: NCT00225485
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
Clinical Trials Authorship and Review
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