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Risperidone vs. Bupropion ER Augmentation of SSRIs in Treatment-Resistant Depression

This study has been completed.
Study NCT00179244.   Last updated on January 31, 2008.   Information provided by Vanderbilt University

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Descriptive Information Fields
Brief Title  Risperidone vs. Bupropion ER Augmentation of SSRIs in Treatment-Resistant Depression
Official Title  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.

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.

Study Phase Phase III
Study Type  Interventional
Study Design  Other, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Primary Outcome Measure  MADRS (Montgomery Asberg's Depression Rating Scale)
Secondary Outcome Measure  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.
Condition  Unipolar Depression
Intervention  Drug: Rispridone (drug) and Bupropion ER (drug)
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  30
Start Date  July 2004
Completion Date April 2005
Eligibility Criteria 

Inclusion Criteria:

  • Male or female 18 years or older
  • DSM-IV diagnosis of major depressive disorder of at least moderate severity, but without psychotic features
  • Ham-D 17 score of 18 or above
  • Have a documentable history of 2 prior adequate trials of antidepressants including an SSRI without sufficient response. A clinically adequate trial is defined as having taken a minimum effective dose of an antidepressant for at least 3 weeks without a significant change in depressive symptoms.
  • Must be currently on an serotonin uptake inhibitor (to include venlafaxine or duloxetine) at an adequate dose for at least 3 weeks.
  • Ability and willingness to provide consent for participation in the study.

Exclusion Criteria:

  • Any medical condition that would preclude treatment with an SSRI, risperidone, or bupropion ER
  • Any clinically significant unstable medical condition
  • Diagnosis of bipolar disorder or a primary diagnosis of any psychotic disorder
  • Current psychotic symptoms (hallucination or delusions)
  • Alcohol or drug abuse or dependence in the last 3 months (excluding nicotine and caffeine dependence/abuse) or abuse within the last month
  • Documented non-response to the combination of a novel antipsychotic or bupropion ER and a SSRI
  • Concomitant use of any psychotropic other than an SSRI or zolpidem (PRN for sleep)
  • Score of 4 on the suicide item of the Ham-D scale and determination by the investigator of significant suicide risk
  • Known sensitivity to risperidone or bupropion ER
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00179244
Organization ID RIS vs. BUP Augmentation Depr.
Secondary IDs †† 040309
Study Sponsor  Vanderbilt University
Collaborators †† Janssen Pharmaceutica N.V., Belgium
Investigators 
Principal Investigator:     Richard C Shelton, MD     Vanderbilt University    
Information Provided By Vanderbilt University
Verification Date January 2008
First Received Date  September 13, 2005
Last Updated Date January 31, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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