Study Evaluating Effexor XR in Elderly Patients With Major Depression.

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Phase III study evaluating Effexor XR in elderly patients with major depression...

Brief Summary

Official Title: “Phase III Study of Effexor XR for the Treatment of Elderly Patients With Depression”

Phase III study evaluating Effexor XR in elderly patients with major depression.

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, 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 Investigator Information

Lead Investigator: Wyeth is now a wholly owned subsidiary of Pfizer Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth is now a wholly owned subsidiary of Pfizer  

Additional Information

Information obtained from ClinicalTrials.gov on February 08, 2012

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

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00225485