Clincosm LogoSign in Get a demo

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

Sponsor
Vanderbilt University (Other)
Overall Status
Completed
CT.gov ID
NCT00179244
Collaborator
Janssen Pharmaceutica (Industry)
30
Enrollment
1
Location
9
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Rispridone (drug) and Bupropion ER (drug)
 Phase 3

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 Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Official Title:
Risperidone vs. Bupropion ER Augmentation of SSRIs in Treatment-Resistant Depression
Study Start Date :
Jul 1, 2004
Actual Study Completion Date :
Apr 1, 2005

Outcome Measures

Primary Outcome Measures

  1. MADRS (Montgomery Asberg's Depression Rating Scale) []

Secondary Outcome Measures

  1. HAM-D(Hamilton Rating Scale for Depression ) 17-item []

  2. BDI (Beck Depression Inventory) []

  3. HAM-A (Hamilton Rating Scale for Anxiety) []

  4. Clinical Global Impression Scale and Severity and Improvement. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vanderbilt University Medical Center Nashville Tennessee United States 37211

Sponsors and Collaborators

  • Vanderbilt University
  • Janssen Pharmaceutica

Investigators

  • Principal Investigator: Richard C Shelton, MD, Vanderbilt University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Richard C. Shelton, Director of Mood Disorder Clinic, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00179244
Other Study ID Numbers:
  • RIS vs. BUP Augmentation Depr.
  • 040309
First Posted:
Sep 15, 2005
Last Update Posted:
Jun 2, 2015
Last Verified:
Jun 1, 2015
Keywords provided by Richard C. Shelton, Director of Mood Disorder Clinic, Vanderbilt University
Treatment Resistant Depression
Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Bupropion

Study Results

No Results Posted as of Jun 2, 2015