Status:
COMPLETED
Risperidone vs. Bupropion ER Augmentation of SSRIs in Treatment-Resistant Depression
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
Janssen Pharmaceutica
Conditions:
Unipolar Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00179244
Start Date
July 1 2004
End Date
April 1 2005
Last Update
June 2 2015
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37211