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

June 1, 2015 updated by: Richard C. Shelton, Vanderbilt University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37211
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
MADRS (Montgomery Asberg's Depression Rating Scale)

Secondary Outcome Measures

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

Janssen Pharmaceutica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

June 2, 2015

Last Update Submitted That Met QC Criteria

June 1, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIS vs. BUP Augmentation Depr.
  • 040309

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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