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Completed

NCT Number: NCT00546494

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Effexor® (Venlafaxine)

Drug

Primary outcomes

  1. 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 outcomes

  1. 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®.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2005
First posted
Oct 19, 2007
Registry last updated
Oct 19, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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