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Study Evaluating Effexor® (Venlafaxine) in Achieving Response and Maintaining Remission

Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression

Intervention: Effexor® (Venlafaxine) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer

Summary

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.

Clinical Details

Official title: A Study Of The Utility Of Effexor (Venlafaxine) In Achieving Response And Maintaining Remission Among Taiwanese Patients With Depression

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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 outcome: 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®.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Additional Information

Starting date: February 2004
Last updated: October 18, 2007

Page last updated: August 23, 2015

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