A 4-Week Study of Mifepristone in the Prevention of Risperidone-Induced Weight Gain in Healthy Male Volunteers

Official Title: “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”

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.

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.

Intervention(s) in this Clinical Trial

• Drug: risperidone plus mifepristone
  • daily risperidone plus mifepristone for 28 days
• Drug: risperidone plus placebo
  • daily risperidone plus placebo for 28 days
• Drug: risperidone-matched placebo plus mifepristone
  • daily risperidone-matched placebo plus mifepristone for 28 days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2
  • risperidone plus mifepristone-matched placebo
• Placebo Comparator: 3
  • risperidone-matched placebo plus mifepristone

Primary Measures

• 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.
  • Time Frame: 28 days
    Safety Issue?: No

Secondary Measures

• 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.
  • Time Frame: 28 days
    Safety Issue?: No
• The safety objective is to evaluate the safety and tolerability of mifepristone in combination with risperidone in healthy male volunteers.
  • Time Frame: 28 days
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Corcept Therapeutics Industry

Overall Clinical Trial Officials and Contacts

Coleman Gross, MD Study Director Corcept Therapeutics  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00698022

Study ID Number: C-1073-205

ClinicalTrials.gov Identifier: NCT00698022

Health Authority: United States: Food and Drug Administration

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