Risperidone vs. Bupropion ER Augmentation of SSRIs in Treatment-Resistant Depression
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.
Drug: Rispridone (drug) and Bupropion ER (drug)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
|Official Title:||Risperidone vs. Bupropion ER Augmentation of SSRIs in Treatment-Resistant Depression|
- MADRS (Montgomery Asberg's Depression Rating Scale)
- HAM-D(Hamilton Rating Scale for Depression ) 17-item
- BDI (Beck Depression Inventory)
- HAM-A (Hamilton Rating Scale for Anxiety)
- Clinical Global Impression Scale and Severity and Improvement.
|Study Start Date:||July 2004|
|Study Completion Date:||April 2005|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179244
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37211|
|Principal Investigator:||Richard C Shelton, MD||Vanderbilt University|