Study Evaluating Effexor® (Venlafaxine) in Achieving Response and Maintaining Remission - Full Text View

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00546494

Purpose

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.

Condition	Intervention	Phase
Depression	Drug: Effexor® (Venlafaxine)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Study Of The Utility Of Effexor® (Venlafaxine) In Achieving Response And Maintaining Remission Among Taiwanese Patients With Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Venlafaxine Venlafaxine hydrochloride

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome 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 Outcome 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®.

Estimated Enrollment:	350
Study Start Date:	February 2004
Study Completion Date:	March 2005

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546494

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	0600B-101547
Study First Received:	October 18, 2007
Last Updated:	October 18, 2007
ClinicalTrials.gov Identifier:	NCT00546494 History of Changes
Health Authority:	Taiwan: Department of Health

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Depression
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder
Serotonin Uptake Inhibitors
Pharmacologic Actions

Behavioral Symptoms
Serotonin Agents
Mental Disorders
Therapeutic Uses
Venlafaxine
Mood Disorders
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 27, 2009