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
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