Risperidone Augmentation Therapy in Patients Who Have Failed or Only Partially Responded to a Trial of Antidepressant
Recruitment status was: Active, not recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Risperidone Augmentation Therapy in Patients Who Have Failed or Only Partially Responded to an Adequate Trial of Antidepressant|
- Depression symptoms,change score on MADRS scale at 4 weeks
- Group differences on HRS-D scores
- Group differences on remission and improvement
- Between group differences on quality-of-life measures
- Group differences of anxiety and psychosocial factors
|Study Start Date:||February 2003|
|Estimated Study Completion Date:||February 2005|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00174577
|United States, Georgia|
|Emory University School of Medicine|
|Atlanta, Georgia, United States, 30329|
|United States, Rhode Island|
|Mood Disorders Program - Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Gabor I Keitner, M.D.||Rhode Island Hospital/Brown University|