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

NCT00698022 Phase 1 COMPLETED Results posted

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.

Details

Lead sponsor	Corcept Therapeutics
Phase	Phase 1
Status	COMPLETED
Enrolment	76
Start date	2008-11
Completion	2009-02

Conditions

• Healthy

Interventions

• Risperidone
• Mifepristone
• Risperidone-matched placebo
• Mifepristone-matched placebo

Primary outcomes

• Change From Baseline in Body Weight — Baseline and 28 days

Countries

India