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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00179244
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : June 2, 2015
Janssen Pharmaceutica
Information provided by (Responsible Party):
Richard C. Shelton, Vanderbilt University

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
Unipolar Depression 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 Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
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 : July 2004
Actual Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00179244

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37211
Sponsors and Collaborators
Vanderbilt University
Janssen Pharmaceutica
Principal Investigator: Richard C Shelton, MD Vanderbilt University Medical Center

Responsible Party: Richard C. Shelton, Director of Mood Disorder Clinic, Vanderbilt University Identifier: NCT00179244     History of Changes
Other Study ID Numbers: RIS vs. BUP Augmentation Depr.
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: June 2015

Keywords provided by Richard C. Shelton, Vanderbilt University:
Treatment Resistant Depression

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors