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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 18, 2007 | ||||
| Last Updated Date | October 18, 2007 | ||||
| Start Date ICMJE | February 2004 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Primary efficacy variable will be the proportion of patients with remission defined as a HAM-D score of less than or equal to 7 at 8 weeks of treatment. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Safety and tolerability will be assessed based on adverse events that occurred during the survey for all patients who received at least one dose of Effexor®. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study Evaluating Effexor® (Venlafaxine) in Achieving Response and Maintaining Remission | ||||
| Official Title ICMJE | A Study Of The Utility Of Effexor® (Venlafaxine) In Achieving Response And Maintaining Remission Among Taiwanese Patients With Depression | ||||
| Brief Summary | This is a study to determine the utility of Effexor® (venlafaxine) in achieving response, including time to response, maintaining remission, and time to remission as measured by the 17-item Hamilton Rating Scale for Depression (HAM-D) and to determine the utility of Effexor® (venlafxine) on the various cluster of symptom scales in the 17-item HAM-D. |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Depression | ||||
| Intervention ICMJE | Drug: Effexor® (Venlafaxine) | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 350 | ||||
| Completion Date | March 2005 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00546494 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 0600B-101547 | ||||
| Study Sponsor ICMJE | Wyeth | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Wyeth | ||||
| Verification Date | October 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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