Unipolar Depression Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label
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