Study Evaluating Venlafaxine ER in Recurrent Depression - Full Text View

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:

Keller MB, Trivedi MH, Thase ME, Shelton RC, Kornstein SG, Nemeroff CB, Friedman ES, Gelenberg AJ, Kocsis JH, Dunner DL, Hirschfeld RM, Rothschild AJ, Ferguson JM, Schatzberg AF, Zajecka JM, Pedersen RD, Yan B, Ahmed S, Musgnung J, Ninan PT. The Prevention of Recurrent Episodes of Depression with Venlafaxine for Two Years (PREVENT) Study: Outcomes from the 2-year and combined maintenance phases. J Clin Psychiatry. 2007 Aug;68(8):1246-56.

Kocsis JH, Thase ME, Trivedi MH, Shelton RC, Kornstein SG, Nemeroff CB, Friedman ES, Gelenberg AJ, Dunner DL, Hirschfeld RM, Rothschild AJ, Ferguson JM, Schatzberg AF, Zajecka JM, Pedersen RD, Yan B, Ahmed S, Musgnung J, Ninan PT, Keller MB. Prevention of recurrent episodes of depression with venlafaxine ER in a 1-year maintenance phase from the PREVENT Study. J Clin Psychiatry. 2007 Jul;68(7):1014-23.

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

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