At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 76 enrolled
Drug / intervention
Risperidone +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Risperidone, Mifepristone, and 2 other interventions for Healthy. Completed, enrolled 76 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesIndia
Collaborators--
Timeline
Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2008
Enrollment StartNov 2008
Primary CompletionFeb 2009
TodayJul 2026
First PostedJun 16, 2008
Enrollment StartNov 1, 2008
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 18.0 years ago
Interventions
Risperidonedrug
risperidone daily for 28 days
Mifepristonedrug
mifepristone daily for 28 days
Risperidone-matched placebodrug
risperidone-matched placebo daily for 28 days
Mifepristone-matched placebodrug
mifepristone-matched placebo daily for 28 days