This is a study to determine the utility of Effexor® (venlafaxine) in achieving response, including time to response, maintaining remission, and time to remission as measured by the 17-item Hamilton Rating Scale for Depression (HAM-D) and to determine the utility of Effexor® (venlafxine) on the various cluster of symptom scales in the 17-item HAM-D...
Date First Received: October 18, 2007
Last Updated: October 18, 2007
Verified by: Wyeth, October 2007
Clinical Trial Phase: Phase 4 | Start Date: February 2004
Overall Status: Completed
Estimated Enrollment: 350
Brief Summary
Official Title: “A Study Of The Utility Of Effexor® (Venlafaxine) In Achieving Response And Maintaining Remission Among Taiwanese 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:
This is a study to determine the utility of Effexor® (venlafaxine) in achieving response, including time to response, maintaining remission, and time to remission as measured by the 17-item Hamilton Rating Scale for Depression (HAM-D) and to determine the utility of Effexor® (venlafxine) on the various cluster of symptom scales in the 17-item HAM-D.
Study Type: Interventional
Study Design: Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Effexor® (Venlafaxine)
Outcome Measures for this Clinical Trial
Primary Measures
- Primary efficacy variable will be the proportion of patients with remission defined as a HAM-D score of less than or equal to 7 at 8 weeks of treatment.
Secondary Measures
- Safety and tolerability will be assessed based on adverse events that occurred during the survey for all patients who received at least one dose of Effexor®.
Criteria for Participation in this Clinical Trial
INCLUSION CRITERIA:
- Patients meeting criteria for a diagnosis of major depression, single or recurrent episode as described by the DSM-IV manual (appendix 1).
- A HAM-D 17 total score of at least 16 at baseline (DSM-IV manual, appendix 2).
- Patients above 18 years of age who meet the eligibility requirements.
EXCLUSION CRITERIA:
- Patients taking MAOI's within 2 weeks prior to the survey.
- Patients known to be suffering from bipolar disorder or schizophrenia.
- Patients who are treatment-resistant, i.e., in the past 3 years have failed (a) three previous adequate trials of greater than or equal to 2 classes of antidepressant medication, or (b) electroconvulsive therapy.
- Drug or alcohol dependence or abuse in the past 6 months per DSM IV criteria.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
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 02, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00546494
Study ID Number: 0600B-101547
ClinicalTrials.gov Identifier: NCT00546494
Health Authority: Taiwan: Department of Health
Clinical Trials Authorship and Review
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