Conditions: Healthy
Keywords: healthy weight gain anti-psychotic risperidone mifepristone mitigation weight loss
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 76
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: risperidone plus mifepristone daily for 28 days arm 2: risperidone plus mifepristone-matched placebo daily for 28 days arm 3: risperidone-matched placebo plus mifepristone daily for 28 days

Interventions: intervention 1: Risperidone intervention 2: Mifepristone intervention 3: Risperidone-matched placebo intervention 4: Mifepristone-matched placebo
Intervention descriptions: intervention 1: risperidone daily for 28 days intervention 2: mifepristone daily for 28 days intervention 3: risperidone-matched placebo daily for 28 days intervention 4: mifepristone-matched placebo daily for 28 days

Protocol document: