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

Completed · Phase 3

Conditions studied: Unipolar Depression

In brief

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.

Key facts

Study ID

NCT00179244

Run by

Vanderbilt University

People needed

30

Starts

2004-07-01

Expected to finish

2005-04-01

Last updated by the study team

2015-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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