Study Evaluating Effexor XR in Chinese Subjects With Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00878748
Recruitment Status : Withdrawn
First Posted : April 9, 2009
Last Update Posted : September 22, 2010
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
This primary purpose of this study is to assess the efficacy and safety of Effexor XR in preventing recurrence in Chinese patients with recurrent major depressive disorder (MDD) following a 1-year maintenance treatment after an 8-week acute treatment and a 6-month continuation treatment phases. The study will also collect data on the prevalence and pattern of co-morbid anxiety and somatic symptoms and their impact on the recurrence of depression.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Effexor XR Other: Effexor XR discontinue Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Prospective and Multi-center Recurrence Prevention Study With Effexor XR in MDD Patients in China
Study Start Date : April 2009
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Effexor XR
Drug: Effexor XR
Effexor XR discontinue
Other: Effexor XR discontinue

Primary Outcome Measures :
  1. time from entering maintenance phase to recurrence of major depression [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Patient Health Questionnaire(PHQ-15),Clinical Global Impressions(CGI),Visual Analogue Scale(VAS),Short Form Health Survey(SF-36) [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria: 1. Males or females, 18 years of age or more; 2. Outpatients; 3. Major depressive disorder based on DSM-IV criteria, with/without current co-morbid anxiety disorder; 4. Has two or more episodes of depression (including the current episode) in the past 5 years, with an interval of at lease 2 months between the end of the previous episode and the beginning of the current episode. 5. The baseline score of 17-item Hamilton Rating Scale for Depression (HAM-D)>=17; 6 If female of childbearing potential, have a negative urine pregnancy test at baseline, if appropriate, and use a medically acceptable method of contraception throughout the study.

Exclusion criteria:1.Hypersensitivity to venlafaxine;2.Received venlafaxine treatment before;3.Clinically significant renal or hepatic disease or any other medical disease that, in the opinion of the investigator, might compromise the study, including seizure disorder (with the exception of a single childhood febrile seizure); 4.Alcohol or drug abuse within the last year;5.A recent history of myocardial infarction or unstable heart disease (within 6 months of baseline);6.Bipolar disorder;7.For female, known or suspected pregnancy or breast feeding;8.Use of a monoamine oxidize inhibitor (MAOI) within 14 days of baseline; use of any investigational drug within 30 days of baseline.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00878748

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Pfizer Call Center Pfizer

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Identifier: NCT00878748     History of Changes
Other Study ID Numbers: 0600X1-4434
First Posted: April 9, 2009    Key Record Dates
Last Update Posted: September 22, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Venlafaxine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs