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

NCT00698022 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2022-02-08

Study results available
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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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Corcept Therapeutics

    lead INDUSTRY

Principal Investigators

  • Coleman Gross, MD · Corcept Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00698022 on ClinicalTrials.gov