NCT00174577

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 84 (planned)
• Sponsor: Rhode Island Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depression

Interventions

Type	Name	Description
DRUG	Risperidone

Timeline

• Start date: 2003-02-01
• Completion: 2005-02-01
• First posted: 2005-09-15
• Last updated: 2005-09-15

Locations

2 sites across 1 country: United States