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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Risperidone
* Drug: Mifepristone
* Drug: Risperidone-matched placebo
* Drug: Mifepristone-matched placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI ≥ 18 and ≤ 23 kg/m2 Able to provide written informed consent Routine clinical laboratory tests either within normal limits or not clinically meaningful if outside of normal limits AST, ALT, Tbili within normal limits at screening Medical and psychiatric history and physical examination devoid of any significant findings that would interfere with participation or interpretation of results in this study Agree to use a barrier method of birth control for 28 days following the last dose of study medication Have maintained a stable weight for at least 6 months prior to Screening Exclusion Criteria: Prior or current history of any psychiatric disorder, including eating disorders such as anorexia nervosa, bulimia nervosa, or binge-eating disorder Positive urine drug screen for any drug of abuse (including amphetamines, cannabinoids, barbiturates, cocaine, opiates, benzodiazepines) unless prescribed by a physician Participation in a clinical investigation of any drug, biological or other investigational therapy within 30 days prior to dosing Have a history of an allergic reaction to either mifepristone or risperidone Any other clinically significant abnormality on screening laboratory tests QTc Bazzett's ≥ 450 msec History of or current major medical condition, which in the opinion of the Investigator would place the patient at undue risk. Receiving any prescription or over-the-counter medications that could potentially affect appetite or weight Any history of a movement disorder such as Tardive Dyskinesia, Parkinsonism Any personal or family history of Neuroleptic Malignant Syndrome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Risperidone plus mifepristone<br>risperidone plus mifepristone daily for 28 days | Drug: Risperidone<br>* risperidone daily for 28 days<br>* Other names: Risperdal;Drug: Mifepristone<br>* mifepristone daily for 28 days<br>* Other names: Corlux;|
| Placebo Comparator: Risperidone plus mifepristone-matched placebo<br>risperidone plus mifepristone-matched placebo daily for 28 days | Drug: Risperidone<br>* risperidone daily for 28 days<br>* Other names: Risperdal;Drug: Mifepristone-matched placebo<br>* mifepristone-matched placebo daily for 28 days<br>|
| Placebo Comparator: Risperidone-matched placebo plus mifepristone<br>risperidone-matched placebo plus mifepristone daily for 28 days | Drug: Mifepristone<br>* mifepristone daily for 28 days<br>* Other names: Corlux;Drug: Risperidone-matched placebo<br>* risperidone-matched placebo daily for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Body Weight |  | Baseline and 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With <5% and <7% Increase From Baseline in Body Weight |  | Baseline and 28 days | 
| Percentage of Participants With One or More Adverse Events |  | Up to 28 days | 
| Percentage of Participants Discontinued From the Study Due to an Adverse Event |  | Up to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy, weight gain, anti-psychotic, risperidone, mifepristone, mitigation, weight loss