Overview

This trial is active, not recruiting.

Condition major depression
Treatment risperidone
Phase phase 3
Sponsor Rhode Island Hospital
Collaborator Janssen Pharmaceutica N.V., Belgium
Start date February 2003
End date February 2005
Trial size 84 participants
Trial identifier NCT00174577, RIS-Dep-402

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
Depression symptoms,change score on MADRS scale at 4 weeks
time frame:
Group differences on HRS-D scores
time frame:
Group differences on remission and improvement
time frame:

Secondary Outcomes

Measure
Between group differences on quality-of-life measures
time frame:
Group differences of anxiety and psychosocial factors
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Risperidone Augmentation Therapy in Patients Who Have Failed or Only Partially Responded to an Adequate Trial of Antidepressant
Principal investigator Gabor I Keitner, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2005.
Information provided to ClinicalTrials.gov by Rhode Island Hospital.