Risperidone vs. Bupropion ER Augmentation of SSRIs in Treatment-Resistant Depression
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00179244|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : June 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Unipolar Depression||Drug: Rispridone (drug) and Bupropion ER (drug)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Risperidone vs. Bupropion ER Augmentation of SSRIs in Treatment-Resistant Depression|
|Study Start Date :||July 2004|
|Actual Study Completion Date :||April 2005|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00179244
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37211|
|Principal Investigator:||Richard C Shelton, MD||Vanderbilt University Medical Center|