Study Evaluating Effexor XR in Chinese Subjects With Major Depressive Disorder

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00878748
First received: April 8, 2009
Last updated: September 21, 2010
Last verified: September 2010

April 8, 2009
September 21, 2010
April 2009
October 2011   (final data collection date for primary outcome measure)
time from entering maintenance phase to recurrence of major depression [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00878748 on ClinicalTrials.gov Archive Site
Patient Health Questionnaire(PHQ-15),Clinical Global Impressions(CGI),Visual Analogue Scale(VAS),Short Form Health Survey(SF-36) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Patient Health Questionnaire (PHQ-15) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Clinical Global Impressions (CGI) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Visual Analogue Scale (VAS) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Short Form Health Survey (SF-36) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
 
 
 
Study Evaluating Effexor XR in Chinese Subjects With Major Depressive Disorder
An Open Label, Prospective and Multi-center Recurrence Prevention Study With Effexor XR in MDD Patients in China

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.

 
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: Effexor XR
  • Other: Effexor XR discontinue
  • Experimental: A
    Effexor XR
    Intervention: Drug: Effexor XR
  • B
    Effexor XR discontinue
    Intervention: Other: Effexor XR discontinue
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2011
October 2011   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00878748
0600X1-4434
Yes
Director, Clinical Trial Disclosure Group, Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
 
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP