Study Evaluating Effexor XR in Chinese Subjects With Major Depressive Disorder
Tracking Information | |||||
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First Received Date ICMJE | April 8, 2009 | ||||
Last Updated Date | September 21, 2010 | ||||
Start Date ICMJE | April 2009 | ||||
Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
time from entering maintenance phase to recurrence of major depression [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00878748 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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 ] | ||||
Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Study Evaluating Effexor XR in Chinese Subjects With Major Depressive Disorder | ||||
Official Title ICMJE | An Open Label, Prospective and Multi-center Recurrence Prevention Study With Effexor XR in MDD Patients in China | ||||
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. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Major Depressive Disorder | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Withdrawn | ||||
Estimated Enrollment ICMJE | 0 | ||||
Estimated Completion Date | October 2011 | ||||
Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | 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. |
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00878748 | ||||
Other Study ID Numbers ICMJE | 0600X1-4434 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer | ||||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Wyeth is now a wholly owned subsidiary of Pfizer | ||||
Verification Date | September 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |