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Study Evaluating Venlafaxine ER in Recurrent Depression

This study is ongoing, but not recruiting participants.

Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00046020
  Purpose

The purpose of this study is to review the long-term comparative efficacy of venlafaxine ER in achieving and sustaining remission (wellness) in patients with recurrent major depression


Condition Intervention Phase
Depressive Disorder, Major
Recurrence
Drug: Venlafaxine ER
Phase IV

MedlinePlus related topics:   Depression   

ChemIDplus related topics:   Fluoxetine    Venlafaxine    Venlafaxine hydrochloride    Fluoxetine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   An Acute and Continuation Phase Study of the Comparative Efficacy Study of Venlafaxine ER (Effexor® XR) and Fluoxetine (Prozac®) in Achieving and Sustaining Remission (Wellness) in Patients With Recurrent Unipolar Major Depression; Followed by a Long Term Randomized, Placebo-Controlled Maintenance Treatment Study in Patients Treated Initially With Venlafaxine ER
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

  • Clinical diagnosis for recurrent major depression

Exclusion Criteria

  • The patient has failed on an adequate trial of fluoxetine, venlafaxine or venlafaxine ER during the current episode of major depression or the patient is treatment-resistant
  • Known hypersensitivity to venlafaxine or fluoxetine
  • History or presence of clinically significant hepatic, cardiovascular or renal disease, or other serious medical disease, including history of seizure disorder
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046020

Sponsors and Collaborators
Wyeth

Investigators
Study Director:     Medical Monitor, MD     Wyeth    
  More Information

Publications indexed to this study:

Study ID Numbers:   0600B-100469
First Received:   September 18, 2002
Last Updated:   May 18, 2006
ClinicalTrials.gov Identifier:   NCT00046020
Health Authority:   United States: Food and Drug Administration

Keywords provided by Wyeth:
Depression  

Study placed in the following topic categories:
Fluoxetine
Depression
Mental Disorders
Venlafaxine
Mood Disorders
Depressive Disorder, Major
Depressive Disorder
Serotonin
Recurrence
Behavioral Symptoms

Additional relevant MeSH terms:
Disease Attributes
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on September 05, 2008




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