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Sponsors and Collaborators: |
Rhode Island Hospital Janssen Pharmaceutica N.V., Belgium Emory University |
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Information provided by: | Rhode Island Hospital |
ClinicalTrials.gov Identifier: | NCT00174577 |
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.
Condition | Intervention | Phase |
---|---|---|
Major Depression |
Drug: Risperidone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Risperidone Augmentation Therapy in Patients Who Have Failed or Only Partially Responded to an Adequate Trial of Antidepressant |
Estimated Enrollment: | 84 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | RIS-Dep-402 |
Study First Received: | September 9, 2005 |
Last Updated: | September 9, 2005 |
ClinicalTrials.gov Identifier: | NCT00174577 |
Health Authority: | United States: Food and Drug Administration |
Dopamine Depression Mental Disorders Risperidone Mood Disorders |
Depressive Disorder, Major Depressive Disorder Serotonin Behavioral Symptoms |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |