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

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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

This Tabular View shows the required WHO registration data elements as marked by ^†

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 ^†

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

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.