Risperidone Augmentation Therapy in Patients Who Have Failed or Only Partially Responded to a Trial of Antidepressant

Study Overview
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Brief Summary
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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
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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.

Official Title
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Risperidone Augmentation Therapy in Patients Who Have Failed or Only Partially Responded to an Adequate Trial of Antidepressant

Conditions
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Major Depression

Intervention / Treatment
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* Drug: Risperidone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Risperidone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between group differences on quality-of-life measures |  |  | 
| Group differences of anxiety and psychosocial factors |  |  |