NCT00698022

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Risperidone	risperidone daily for 28 days
DRUG	Mifepristone	mifepristone daily for 28 days
DRUG	Risperidone-matched placebo	risperidone-matched placebo daily for 28 days
DRUG	Mifepristone-matched placebo	mifepristone-matched placebo daily for 28 days

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-06-16
• Last updated: 2022-02-08
• Results posted: 2012-05-04

Locations

1 site across 1 country: India