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| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | January 31, 2008 | ||||
| Start Date ICMJE | July 2004 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
MADRS (Montgomery Asberg's Depression Rating Scale) | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00179244 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Risperidone vs. Bupropion ER Augmentation of SSRIs in Treatment-Resistant Depression | ||||
| Official Title ICMJE | Risperidone vs. Bupropion ER Augmentation of SSRIs in Treatment-Resistant Depression | ||||
| Brief Summary | The purpose of this study is to evaluate the comparative effectiveness of Risperdal (risperidone) or bupropion ER (extended release) combined with a SSRI medication and to test the relative safety of the combinations. |
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| Detailed Description | Major depression is a severe disorder with serious consequences. Effective treatments are available; however, in clinical trials 30-40% of patients do not experience even a 50% reduction in depression severity scores, while 50-70% fail to achieve a full therapeutic response. Futhermore, impairment from the disorder continues essentially unabated in patients who are treated but do not fully remit. If anything, the situation is at least as bad or not worse in clinical practice. Clearly, alternatives are needed to manage this common clinical condition. The addition of bupropion ER (extended release) to an SSRI has empirical support, and has become the most common augmentation strategy in the US. A comparative trial of the combination of risperidone or bupropion ER added to an SSRI in treatment resistant deperssion could help support risperidone for this condition; such a trial seems warranted at this time. Patients who are currently on a SSRI at an adequate dosage for at least 3 weeks with no response, will be randomly assigned (open-label) to either risperidone or bupropion ER augmentation for a period of 6 weeks. Patients will be followed weekly at the beginning and bi-weekly towards the end of the trial to compare the response of each group. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Other, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Unipolar Depression | ||||
| Intervention ICMJE | Drug: Rispridone (drug) and Bupropion ER (drug) | ||||
| 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 | 30 | ||||
| Completion Date | April 2005 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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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 | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00179244 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | RIS vs. BUP Augmentation Depr., 040309 | ||||
| Study Sponsor ICMJE | Vanderbilt University | ||||
| Collaborators ICMJE | Janssen Pharmaceutica N.V., Belgium | ||||
| Investigators ICMJE |
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| Information Provided By | Vanderbilt University | ||||
| Verification Date | January 2008 | ||||
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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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