Study Evaluating Effexor XR for Major Depression.

Study Evaluating Effexor XR for Major Depression.

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Date First Received: September 12, 2005

Last Updated: May 22, 2007

Verified by: Wyeth, May 2007

Clinical Trial Phase: Phase 3 | Start Date: June 2004

Overall Status: Completed

Estimated Enrollment: 590

Brief Summary

Official Title: “Phase III Multi-Center, Double-Blind, Comparative Study of Effexor XR for the Treatment of Depression”

Condition Keyword(s):

Additional Keyword(s) Provided by Sponsor:

Condition MeSH Term(s), Assigned with an Experimental Algorithm:

Intervention MeSH Term(s), Assigned with an Experimental Algorithm:

Study Evaluating Effexor XR for Major Depression.

Study Type: Interventional

Study Design: Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Intervention(s) in this Clinical Trial

  • Drug: Effexor XR
  • Drug: Milnacipran

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" at the 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: 20 Years

Maximum Age for this Clinical Trial: 64 Years

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/NCT00225511

Study ID Number: 0600B1-816

ClinicalTrials.gov Identifier: NCT00225511

Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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