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

NCT00179244 | Completed Phase 3

• 2 other identifiers: RIS vs. BUP Augmentation Depr.040309
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Unipolar Depression

Keywords

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

• MADRS (Montgomery Asberg's Depression Rating Scale)

Secondary Outcomes (4)

• 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.

Interventions

Rispridone (drug) and Bupropion ER (drug) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Vanderbilt University: lead
• Janssen Pharmaceutica: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37211, United States

Location

MeSH Terms

Conditions

Depressive Disorder; Depressive Disorder, Treatment-Resistant

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• Richard C Shelton, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Mood Disorder Clinic

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: July 1, 2004
• Study Completion: April 1, 2005
• Last Updated: June 2, 2015

Record last verified: 2015-06

Locations

US (1)