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A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers

Healthy Clinical Trial

Official title:
A 4-week, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers

Clinical Trial Summary

This is a 28-day, single-center, double-blind, placebo-controlled inpatient study of the administration of risperidone alone or in combination with mifepristone in healthy adult male volunteers to determine the average change in absolute weight at Day 28 compared to baseline.

Clinical Trial Description

This is a 28-day, single-center, double-blind, placebo-controlled inpatient study of the administration of risperidone alone or in combination with mifepristone in healthy adult male volunteers. The primary study objective is to determine the mean change in absolute weight at Day 28 compared to baseline in normal healthy male volunteers treated with risperidone plus mifepristone or risperidone alone. The secondary study objectives are to determine the mean percent change in baseline body weight; and the proportion of subjects that gain less than 5% and less than 7% of their baseline body in the treatment groups. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00698022
Study type Interventional
Source Corcept Therapeutics
Contact
Status Completed
Phase Phase 1
Start date November 2008
Completion date February 2009
View Details
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