Back to resultsRisperidone Augmentation Therapy in Patients Who Have Failed or Only Partially Responded to a Trial of Antidepressant
Primary Purpose
Major Depression
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Risperidone
Sponsored by
About this trial
This is an interventional treatment trial for Major Depression
Eligibility Criteria
Inclusion Criteria: patients with major depression or partially remitted depression currently receiving an adequate trial of an antidepressant Exclusion Criteria: diagnosis of bipolar I or bipolar II disorder psychotic features substance dependence or abuse in the past three months
Sites / Locations
- Emory University School of Medicine
- Mood Disorders Program - Rhode Island Hospital
Outcomes
Primary Outcome Measures
Depression symptoms,change score on MADRS scale at 4 weeks
Group differences on HRS-D scores
Group differences on remission and improvement
Secondary Outcome Measures
Between group differences on quality-of-life measures
Group differences of anxiety and psychosocial factors
Full Information
NCT ID
NCT00174577
First Posted
September 9, 2005
Last Updated
September 9, 2005
Sponsor
Rhode Island Hospital
Collaborators
Janssen Pharmaceutica N.V., Belgium, Emory University
1. Study Identification
Unique Protocol Identification Number
NCT00174577
Brief Title
Risperidone Augmentation Therapy in Patients Who Have Failed or Only Partially Responded to a Trial of Antidepressant
Official Title
Risperidone Augmentation Therapy in Patients Who Have Failed or Only Partially Responded to an Adequate Trial of Antidepressant
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rhode Island Hospital
Collaborators
Janssen Pharmaceutica N.V., Belgium, Emory University
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the safety and efficacy of risperidone augmentation in patients who have failed to respond or only partially responded to an adequate trial of an antidepressant.
Detailed Description
Specific Aims: The goal of this study was to assess the safety and efficacy of risperidone augmentation in patients with major depression who failed to respond, or only partially responded, to an adequate trial of an antidepressant medication. Patients who met this criteria received adjunctive risperidone (1- 3 mg.) for an additional four-week treatment trial.
Subject Population: A total sample of 84 patients completed the study at two sites (Rhode Island Hospital/Brown University, n=42, Emory University, n=42).
Methods/Design: Patients who met criteria for unipolar depression and failed to respond, or partially responded, to an adequate trial of antidepressant medication were randomized to risperidone or a placebo for an additional 4 week treatment trial while continuing on the same dose of their antidepressant medication. Randomization was at a 2:1 ratio of risperidone to placebo.
Data Analysis: Patient outcome (recovery status) of the two treatment conditions were compared using a MADRS rating < 10 to denote remission while improvement was defined as a 50% decrease from baseline to end of study. Odds ratio were examined to see if risperidone augmentation significantly affected the chance of recovery from depression at the end of 4 weeks of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
84 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Risperidone
Primary Outcome Measure Information:
Title
Depression symptoms,change score on MADRS scale at 4 weeks
Title
Group differences on HRS-D scores
Title
Group differences on remission and improvement
Secondary Outcome Measure Information:
Title
Between group differences on quality-of-life measures
Title
Group differences of anxiety and psychosocial factors
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with major depression or partially remitted depression
currently receiving an adequate trial of an antidepressant
Exclusion Criteria:
diagnosis of bipolar I or bipolar II disorder
psychotic features
substance dependence or abuse in the past three months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabor I Keitner, M.D.
Organizational Affiliation
Rhode Island Hospital/Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Mood Disorders Program - Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
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Risperidone Augmentation Therapy in Patients Who Have Failed or Only Partially Responded to a Trial of Antidepressant
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